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These links take users to additional information, announcements, and government documents mentioned in BioCentury's publications.

Allergic diseases (PDF files) (December 22, 2008)
CHMP guideline on developing allergen products for specific immunotherapy of allergic diseases, and an overview of comments received on the guidance.

Antiepileptic drugs (December 22, 2008)
FDA notice requiring that the labels of antiepileptic drugs be updated to warn of increased risk of suicidality (see BioCentury Extra, Tuesday, Dec. 16).

Biologics (PDF file) (December 22, 2008)
Work plan for the EMEA biologics working program (BWP) for 2009.

CHMP (PDF file) (December 22, 2008)
Summary of actions taken at the Dec. 15-18 meeting of EMEA's Committee for Medicinal Products for Human Use (CHMP).

Healthcare reform (PDF files) (December 22, 2008)
Report from the Congressional Budget Office presenting 115 specific options for changing the way healthcare is financed and delivered, including estimated costs and/or savings, and a CBO estimate of the effect of rising health insurance costs on federal healthcare spending and insurance coverage for Americans (see BioCentury Extra, Thursday, Dec. 18).

Influenza (PDF files)
FDA draft guidance on postmarketing adverse event reporting for therapeutics, medical devices and dietary supplements during an influenza pandemic.
U.S. Department of Health and Human Services (HHS) guidance for the use and stockpiling of antiviral drugs during an influenza pandemic.

Orphan drugs (PDF file) (December 22, 2008)
FDA notice for Orphan Product Development (OPD) grants to support the clinical development of orphan drugs.

Pediatric drugs (PDF file) (December 22, 2008)
Summary of actions taken at the Dec. 10-12 meeting of EMEA's Pediatric Committee (PDCO).

Safety (PDF file) (December 22, 2008)
FDA draft guidance on evaluating safety of genotoxic and carcinogenic impurities in drug substances and drug products.

Product documentation (PDF files) (December 22, 2008)
Adenuric: NICE final guidance recommending use of Adenuric febuxostat to manage chronic hyperuricemia in gout for patients who are intolerant to or contraindicated for allopurinol, from Ipsen Group (Euronext:IPN) (see BioCentury Extra, Wednesday Dec. 17).
Aflunov: EMEA withdrawal assessment report for Aflunov H5N1 pre-pandemic influenza vaccine to prevent H5N1 influenza infection, from Novartis AG (NYSE:NVS; SWX:NOVN).
Norvir: CHMP revised EPAR updating the SPC to include information on the potential for Norvir ritonavir to induce QTc and PR interval prolongation to treat HIV-1 infection, from Abbott Laboratories (NYSE:ABT).
Remicade: NICE final guidance recommending use of Remicade infliximab to treat acute exacerbations of severely active ulcerative colitis (UC) in patients for whom cyclosporin is contraindicated or clinically inappropriate, from Johnson & Johnson (NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP) (see BioCentury Extra, Wednesday, Dec. 17).
Rozerem: EMEA withdrawal assessment report for Rozerem ramelteon to treat primary insomnia, from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
Vancocin: FDA draft guidance on the design of bioequivalence studies to support ANDAs for vancomycin to treat enterocolitis caused by Staphylococcus aureus and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. Vancocin vancomycin is from ViroPharma Inc. (NASDAQ:VPHM) (see BioCentury Extra, Monday, Dec. 15).

Biosimilars (PDF file) (December 15, 2008)
Work plan for the EMEA biosimilar medicinal products working program (BMWP) for 2009.

Gene therapy (PDF file) (December 15, 2008)
Work plan for the EMEA gene therapy products working program (GTWP) for 2009.

ICH (December 15, 2008)
Presentations from the first European regional meeting of the International Conference on Harmonisation on Nov. 14 in Brussels.

K-Ras (December 15, 2008)
Briefing documents for the Dec. 16 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to discuss retrospective biomarker analyses intended to support the addition of information regarding wild-type K-Ras to product labeling for marketed colorectal cancer drugs, Vectibix panitumumab from Amgen Inc. (NASDAQ:AMGN), and Erbitux cetuximab from Bristol-Myers Squibb Co. (NYSE:BMY), Eli Lilly and Co. (NYSE:LLY) and Merck KGaA (Xetra:MRK) (see BioCentury Extra, Friday, Dec. 12).

LABAs (December 15, 2008)
Briefing documents for the Dec. 10-11 joint meeting of FDA's Pulmonary-Allergy Drugs, Drug Safety & Risk Management, and the Pediatric advisory committees to review the risk-benefit of long-acting adrenergic receptor beta 2 agonists (LABAs) for the maintenance treatment of asthma patients (see "The LABArinth of risk").

Medical devices (PDF file) (December 15, 2008)
FDA guidance to determine the type of regulatory submission that may be required when a device subject to PMA is modified.

Oncolytic viruses (PDF file) (December 15, 2008)
International Conference on Harmonisation (ICH) considerations for developing oncolytic viruses.

Safety (December 15, 2008)
European Commission initiative for the pharmaceutical sector that includes legislative measures seeking to improve patient access to information, strengthen safety monitoring and address counterfeit medicines (see BioCentury Extra, Wednesday, Dec. 10).

Product documentation (December 15, 2008)
Evicel: New CHMP EPAR on Evicel for use as a supportive treatment in surgery where standard surgical techniques are insufficient for improvement of hemostasis, and as suture support for hemostasis in vascular surgery, from Omrix Biopharmaceuticals Inc. (NASDAQ:OMRI) and Johnson & Johnson (NYSE:JNJ).
Imagify: Briefing documents for the Dec. 10 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 16-1, with one abstention, that the benefits of Imagify perflubutane do not justify the risks associated with its use to detect coronary artery disease (CAD), from Acusphere Inc. (NASDAQ:ACUS) (see BioCentury Extra, Wednesday, Dec. 10).
MabThera: CHMP revised EPAR updating the SPC to include cases of progressive multifocal leukoencephalopathy (PML) in patients taking MabThera (Rituxan - U.S.) rituximab to treat rheumatoid arthritis (RA), from Roche (SWX:ROG). (PDF file)
Xyrem: CHMP revised EPAR updating the SPC and package leaflet to warn of weight decrease, suicidal ideation, suicidal attempt, insomnia, initial insomnia and restless legs syndrome in patients receiving Xyrem sodium oxybate to treat narcolepsy with cataplexy, from Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ). (PDF file)

Advanced therapies (PDF file) (December 8, 2008)
CHMP guidelines relating to post-authorization follow-up of efficacy and adverse reactions, and risk management for advanced therapy medicinal products (ATMPs).

Allergen products (PDF file) (December 8, 2008)
CHMP guideline on the manufacturing and quality control of allergen products of biological origin.

Antipsychotics (PDF files) (December 8, 2008)
CHMP opinion, assessment report and Q&A on the use of conventional antipsychotics to treat dementia in the elderly.

Asthma (December 8, 2008)
Briefing documents for the Dec. 10-11 joint meeting of FDA's Pulmonary-Allergy Drugs, the Drug Safety and Risk Management and the Pediatric advisory committees to discuss the risk-benefit assessment of long-acting adrenergic receptor beta 2 agonists (LABAs) to treat asthma (see BioCentury Extra, Friday, Dec. 5).

Clinical trials (PDF file) (December 8, 2008)
FDA guidance for sponsors, investigators and institutional review boards (IRBs) on data retention when subjects withdraw from clinical trials.

CMS (PDF file) (December 8, 2008)
Centers for Medicare & Medicaid Services Issues Paper regarding a plan to transition to a value-based purchasing (VBP) program for services from healthcare professionals.

Competition (PDF file) (December 8, 2008)
EC preliminary report on its inquiry into competition in the pharma sector (see BioCentury Extra, Monday, Dec. 1).

Labeling (PDF file) (December 8, 2008)
FDA draft guidance on the contents of a complete submission for the evaluation of proprietary names.

Manufacturing (PDF file) (December 8, 2008)
FDA guidance on sharing or contracting parts of manufacturing of biological products.

NHS (December 8, 2008)
U.K.'s NHS briefing document for NHS Evidence, a web-based service that will consolidate information from a range of sources including clinical data, clinical experience, prescribing and safety information and NICE technology appraisals (see BioCentury Extra, Tuesday, Dec. 2).

Radiopharmaceuticals (December 8, 2008)
CHMP revised guideline on specific additional information that needs to be submitted with marketing authorization applications for radiopharmaceuticals.

Safety (December 8, 2008)
Online resource on WebMD's website that will feature FDA consumer health information, including alerts for emerging safety issues and product recalls (see BioCentury Extra, Wednesday, Dec. 3).

TNF alpha inhibitors (PDF file) (December 8, 2008)
NICE decision upholding an appeal of a final appraisal determination for TNF alpha inhibitors, concluding that the appraisal process for sequential use of TNF alpha inhibitors to treat rheumatoid arthritis should be restarted (see BioCentury Extra, Monday, Nov. 24).

Product documentation (December 8, 2008)
Coartem: Briefing documents for the Dec. 3 meeting of FDA's Anti-Infective Drugs Advisory Committee to review Coartem artemether/lumefantrine to treat uncomplicated malaria infection due to Plasmodium falciparum, from Novartis AG (NYSE:NVS; SWX:NOVN) (see "Vouching for Coartem").
� Diractin: EMEA withdrawal assessment report and Q&A for Diractin ketoprofen 22.9 mg gel to treat inflammation and pain associated with osteoarthritis, from Idea AG. (PDF files)
Pegasys: CHMP revised EPAR updating the SPC to include data that showed long-term therapy with Pegasys peginterferon alfa-2a to treat chronic HCV did not reduce the rate of disease progression in patients with advanced fibrosis or cirrhosis, from Roche (SWX:ROG). (PDF file)
PegIntron: CHMP revised EPAR updating the SPC and package leaflet to include pericarditis, bipolar disorders and mania as adverse reactions for PegIntron pegylated interferon alfa-2b to treat chronic HCV, from Enzon Pharmaceuticals Inc. (NASDAQ:ENZN) and Schering-Plough Corp. (NYSE:SGP). (PDF file)
Rebetol: CHMP revised EPAR updating the SPC and package leaflet to include postmarketing reports of adverse events for Rebetol ribavirin when combined with interferon alfa-2b to treat chronic HCV, from Enzon Pharmaceuticals Inc. (NASDAQ:ENZN) and Schering-Plough Corp. (NYSE:SGP). (PDF file)
Tarceva: NICE final guidance recommending Tarceva erlotinib as an alternative to docetaxel as a second-line treatment for non-small cell lung cancer (NSCLC) only when overall treatment costs of Tarceva are the same as those of docetaxel, from Roche (SWX:ROG) (see BioCentury Extra, Wednesday, Nov. 26). (PDF file)
Taxotere: CHMP Q&A on the withdrawal of a marketing application to extend the label for Taxotere docetaxel to include the treatment of operable HER2-positive breast cancer when used in combination with trastuzumab, with or without carboplatin, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Vibativ: EMEA Q&A on the withdrawal of an MAA for Vibativ telavancin to treat complicated skin and soft tissue infections (cSSTI), from Astellas Pharma Inc. (Tokyo:4503) and Theravance Inc. (NASDAQ:THRX). (PDF file)

CHMP (PDF file) (November 24, 2008)
Summary of actions taken at the Nov. 17-20 meeting of EMEA's Committee for Medicinal Products for Human Use (CHMP).

Medicare (PDF file) (November 24, 2008)
Discussion draft of legislation by Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Mont.) that would establish a value-based purchasing program for in-patient hospital care in the Medicare program (see BioCentury Extra, Friday, Nov. 21).

Priority review (November 24, 2008)
Website launched by the non-profit BIO Ventures for Global Health (BVGH) with information on FDA's Priority Review Voucher program to promote investment in drugs and vaccines for neglected tropical diseases.

Product documentation (November 24, 2008)
Forcaltonin: EMEA public statement on the withdrawal of marketing authorization for Forcaltonin injectable calcitonin to treat Paget's disease and hypercalcemia and to prevent bone loss associated with osteoporotic fractures, from Unigene Laboratories Inc. (OTCBB:UGNE). (PDF file)
Hycamtin: CHMP revised EPAR updating the SPC and package leaflet to include a warning on the frequency of interstitial lung disease in patients receiving Hycamtin topotecan to treat relapsed small cell lung cancer (SCLC), second-line treatment of metastatic carcinoma of the ovary and for use with cisplatin to treat Stage IVb recurrent or persistent carcinoma of the cervix that cannot be treated with surgery and/or radiation therapy, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Iclaprim: Briefing documents for the Nov. 20 meeting of FDA's Anti-Infective Drugs Advisory Committee, which voted 17-2 that safety and efficacy had not been demonstrated for iclaprim to treat complicated skin and skin structure infections (cSSSIs), from Arpida Ltd. (SWX:ARPN) (see Cover Story).
Ixempra: CHMP Q&A on its negative opinion for an MAA for Ixempra ixabepilone to treat advanced or metastatic breast cancer, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Oritavancin: Briefing documents for the Nov. 19 meeting of FDA's Anti-Infective Drugs Advisory Committee, which voted 10-8 that the safety and efficacy had not been demonstrated for oritavancin to treat complicated skin and skin structure infections (cSSSIs), from Targanta Therapeutics Corp. (NASDAQ:TARG) (see Cover Story).
Raptiva: Dear Healthcare Professional letter warning of a second case of progressive multifocal leukoencephalopathy (PML) in a patient receiving Raptiva efalizumab to treat chronic plaque psoriasis, from Genentech Inc. (NYSE:DNA) (see BioCentury Extra, Monday, Nov. 17).
Sovrima: CHMP Q&A on its negative opinion for an MAA for Sovrima idebenone to treat Friedreich's ataxia, from Santhera Pharmaceuticals Holding AG (SWX:SANN).
Telavancin: Briefing documents for the Nov. 19 meeting of FDA's Anti-Infective Drugs Advisory Committee, which voted 21-5 in favor of telavancin to treat complicated skin and skin structure infections (cSSSIs) and said its label should include strong cautions against exposing pregnant women to the compound, from Theravance Inc. (NASDAQ:THRX) (see Cover Story).
Uloric: Briefing documents for the Nov. 24 meeting of FDA's Arthritis Advisory Committee to discuss an NDA for Uloric febuxostat to treat hyperuricemia in patients with gout, from Ipsen Group (Euronext:IPN), Teijin Pharma Ltd. and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Thursday, Nov. 20).

Anti-infective drugs (PDF files) (November 17, 2008)
Briefing documents from FDA and Targanta Therapeutics Corp. (NASDAQ:TARG) for the Nov. 18 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss the justification of the non-inferiority margin for studies involving complicated skin and skin structure infections (cSSSIs) (see BioCentury Extra, Monday, Nov. 10).

Healthcare reform (PDF file) (November 17, 2008)
Proposals from Sen. Max Baucus (D-Mont.) calling for the creation of a nationwide health insurance pool and temporarily lowering the eligibility age for Medicare by a decade to 55 (see BioCentury Extra, Wednesday, Nov. 12).

Orphan drugs (PDF files) (November 17, 2008)
� Updated EMEA list of approved medicines with Orphan Drug status.
Summary of actions taken at the Nov. 4-5 plenary meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Product documentation (November 17, 2008)
Byetta: CHMP revised EPAR updating the SPC to include reports of altered renal function and acute pancreatitis in patients receiving Byetta exenatide to treat Type II diabetes, from Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) and Eli Lilly and Co. (NYSE:LLY). (PDF file)
Ceplene: CHMP EPAR for Ceplene histamine dihydrochloride for use in combination with interleukin-2 (IL-2) to maintain remission and prevent relapse in patients with acute myelogenous leukemia (AML) in first remission, from EpiCept Corp. (NASDAQ:EPCT; SSE:EPCT)
Cialis: CHMP revised EPAR updating the SPC to include data from four clinical studies evaluating the interaction between various adrenergic receptor alpha (ADRA) blocking agents and Cialis tadalafil to treat erectile dysfunction (ED), from Eli Lilly and Co. (NYSE:LLY). (PDF file)
Ellefore: EMEA Q&A on the withdrawl of an MAA for Ellefore desvenlafaxine to treat major depressive disorder (MDD), from Wyeth (NYSE:WYE). (PDF file)
Embeda: Briefing documents for the Nov. 14 joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety & Risk Management advisory committees to discuss the ability of Embeda morphine capsules to reduce abuse, from Alpharma Inc. (NYSE:ALO) (see Cover Story).
Januvia: CHMP revised EPAR updating the SPC and package leaflet to include postmarketing reports of hypersensitivity reactions in patients treated with Januvia sitagliptin to treat Type II diabetes, from Merck & Co. Inc. (NYSE:MRK). (PDF file)
Orplatna: EMEA withdrawal assessment report for Orplatna satraplatin to treat hormone-refractory prostate cancer (HRPC), from GPC Biotech AG (Xetra:GPC; NASDAQ:GPCB) and Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI). (PDF file)
Remoxy: Briefing documents for the Nov. 13 joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety & Risk Management advisory committees to discuss the ability of Remoxy oxycodone to reduce abuse, from Pain Therapeutics Inc. (NASDAQ:PTIE) (see Cover Story).
RotaTeq: CHMP revised EPAR updating the SPC and package leaflet to include data from an extension of the REST trial of RotaTeq rotavirus vaccine to prevent gastroenteritis due to rotavirus infection in infants from the age of 6 weeks, from Merck & Co. Inc. (NYSE:MRK). (PDF file)
Sebivo: CHMP revised EPAR updating the SPC and package leaflet to include safety and efficacy data from two studies at 104 weeks and data on resistance for Sebivo telbivudine to treat chronic HBV, from Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) and Novartis AG (NYSE:NVS; SWX:NOVN). (PDF file)
Tamiflu: CHMP revised EPAR updating the SPC to include data on neuropsychiatric adverse events in children and adolescents taking Tamiflu oseltamivir to treat and prevent influenza, from Roche (SWX:ROG) and Gilead Sciences Inc. (NASDAQ:GILD).
Vimpat: EMEA Q&A on the withdrawal of an MAA for Vimpat lacosamide to treat diabetic neuropathic pain in adults, from UCB Group (Euronext:UCB).
Xarelto: CHMP EPAR for Xarelto rivaroxaban to prevent venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery, from Bayer AG (Xetra:BAY) and Johnson & Johnson (NYSE:JNJ).

HIV (PDF file) (November 10, 2008)
Updated U.S. Department of Health and Human Services (HHS) guidelines on the use of antiretroviral agents for HIV in adults and adolescents, including naming Truvada emtricitabine/tenofovir from Gilead Sciences Inc. (NASDAQ:GILD) as the sole preferred dual nucleoside reverse transcriptase inhibitor (NRTI) treatment for patients naive to antiretroviral therapy and relegating Epzicom abacavir/lamivudine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to an "alternative" treatment from a "preferred" treatment (see BioCentury Extra, Monday, Nov. 3).

Lung cancer (PDF file) (November 10, 2008)
NICE draft scope for consultation to update clinical guidelines for diagnosing and treating lung cancer.

NICE (November 10, 2008)
Recommendations by U.K. National Cancer Director Mike Richards for improving access to medicines for National Health Service (NHS) patients, supporting a NICE proposal for greater flexibility in appraising more expensive drugs for terminally ill patients; and working closely with the pharmaceutical industry on new and more flexible pricing arrangements to increase access to new drugs (see BioCentury Extra, Tuesday, Nov. 4).
— U.K.'s Department of Health draft guidance to NHS trusts for patients who wish to pay for additional private care (see BioCentury Extra, Tuesday, Nov. 4).
— Conservative Party proposals for reforming NICE to improve patient access to new drugs.

Preemption (PDF file) (November 10, 2008)
U.S. Supreme Court transcript of the oral arguments in Wyeth (NYSE:WYE) v. Levine, a case involving FDA preemption of state product liability law in pharmaceutical tort actions (see BioCentury, Nov. 10).

Renal cell carcinoma (PDF file) (November 10, 2008)
NICE letter to consultees and commentators informing them of the need for an additional meeting before the issuance of a final appraisal for the treatment of renal cell carcinoma (RCC).

Tropical diseases (PDF file) (November 10, 2008)
FDA notice of a Dec. 12 public hearing to discuss adding diseases to the list of tropical diseases recognized under the FDA Amendments Act of 2007 (FDAAA) (see BioCentury Extra, Wednesday, Nov. 5).

Venture capital (PDF files) (November 10, 2008)
— University of Virginia Management Co. third quarter investment report.

Biological threats (PDF file) (November 3, 2008)
FDA and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) memorandum of understanding (MOU) agreeing to share information related to biological threat agents and diagnostic tests for the agents to assist in preparing for emergencies in which the tests may be used.

Biosimilars (PDF file) (November 3, 2008)
EMEA Q&A on biosimilar medications.

CMS (PDF files) (November 3, 2008)
— The Centers for Medicare & Medicaid Services statement of policy clarifying how it will make coverage decisions about off-label uses of cancer therapies using four compendia: American Hospital Formulary Service-Drug Information; National Comprehensive Cancer Network (NCCN) Drugs & Biologics; Thomson Micromedex DrugDex; and Elsevier Gold Standard's Clinical Pharmacology (see BioCentury Extra, Monday, Oct. 27).
— CMS final rule for the outpatient prospective payment system (OPPS) updating payment policies and rates for drugs, biologics and radiopharmaceuticals for 2009 (see BioCentury Extra, Friday, Oct. 31).

EMEA (PDF file) (November 3, 2008)
Summary of actions taken at the Oct. 20-23 plenary meeting of EMEA's CHMP.

Healthcare reform (November 3, 2008)
Website of the Lewin Group, containing coverage and cost comparisons for the U.S. presidential candidates (see BioCentury, Nov. 3).

Osteoporosis (November 3, 2008)
— NICE final guidance for primary prevention of fractures in postmenopausal women with osteoporosis recommending the use of Fosamax alendronate from Merck & Co. Inc. (NYSE:MRK) in women 70 years or older and for women younger than 70 years old with certain risk factors; Actonel risedronate or Didronel etidronate from Procter & Gamble Co. (NYSE:PG) as first alternative treatment options; and Protelos strontium ranelate from Les Laboratoires Servier as an alternative to Fosamax, Actonel and Didronel (see BioCentury Extra, Monday, Oct. 27).
— NICE final guidance for secondary prevention of fractures in postmenopausal women with osteoporosis recommending the use of Fosamax alendronate from Merck & Co. Inc. (NYSE:MRK) in women of all ages; Actonel risedronate or Didronel etidronate from Procter & Gamble Co. (NYSE:PG) as first alternative treatment options; and Evista raloxifene and Forteo teriparatide from Eli Lilly and Co. (NYSE:LLY) as an alternative treatment option (see BioCentury Extra, Monday, Oct. 27).

Stem cells (PDF file) (November 3, 2008)
Text of the Human Fertilisation and Embryology Bill, which seeks to allow scientists to use hybrid animal-human embryos for stem cell research in the U.K., as passed in the U.K. House of Lords (see BioCentury Extra, Thursday, Oct. 30).

Product documentation (November 3, 2008)
Ketek: CHMP revised EPAR updating the SPC on monitoring rhabdomyolysis with statins, to warn about potential confusion and hallucination, and to add anosmia, agueusia, hypersensitivity, arthralgia, myalgia, confusion and hallucination as adverse reactions for Ketek telithromycin to treat community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis caused by Streptococcus pyogenes, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Lucentis: CHMP revised EPAR updating the SPC and package leaflet to include updated safety, efficacy and pharmacokinetic information for Lucentis ranibizumab to treat neovascular (wet) age-related macular degeneration (AMD), from Novartis AG (NYSE:NVS; SWX:NOVN) and Genentech Inc. (NYSE:DNA). (PDF file)
Revlimid: NICE preliminary appraisal recommending against the use of Revlimid lenalidomide in combination with dexamethasone to treat multiple myeloma (MM) in patients who have received at least one prior therapy, from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Tuesday, Oct. 28).

CBER (PDF file) (October 27, 2008)
Fiscal year 2007 annual report from FDA's Center for Biologics Evaluation and Research.

Drug imports (PDF file) (October 27, 2008)
U.S. Government Accountability Office (GAO) report on the need to improve FDA's foreign drug inspection program.

Pediatric Drugs (PDF file) (October 27, 2008)
Summary of actions taken at the Oct. 15-17 meeting of EMEA's Pediatric Committee (PDCO).

Product documentation (October 27, 2008)
Acomplia: CHMP Q&A on the suspension of the marketing authorization for Acomplia rimonabant to treat obesity, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Opgenra: CHMP Q&A on its marketing authorization for Opgenra eptoermin alfa for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or who must undergo the procedure, from Stryker Biotech. (PDF file)
Prepandemic influenza vaccine (H5N1): CHMP EPAR for prepandemic influenza vaccine (H5N1) for vaccination against H5N1 subtype of influenza A virus, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

Cardiovascular disease (PDF files) (October 20, 2008)
CHMP guideline on the evaluation of medicinal products to prevent cardiovascular disease and an overview of comments received on the draft guidance.

Crohn's disease (PDF file) (October 20, 2008)
Overview of comments received on EMEA draft guideline on developing medicinal products to treat Crohn's disease.

Drug safety (October 20, 2008)
FDA drug safety website as required by Food and Drug Administration Amendments Act (FDAAA) of 2007 (see BioCentury Extra, Wednesday, Oct. 15).

Patents (October 20, 2008)
U.S. Patent & Trademark Office (PTO) reply brief submitted to U.S. Court of Appeals for the Federal Circuit (CAFC) arguing why the court should overturn a district court decision that voided new rules aimed at limiting the number of continuing applications, requests for continued examination and claims allowed for patent applications.

Pharmacoepidemiology/pharmacovigilance (PDF files) (October 20, 2008)
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) report of its April 18 meeting, including minutes of working groups related to research standards and guidances, transparency and independence; EU inventory of data sources for research; and inventory of EU research centers in ENCePP.

Virus safety (PDF file) (October 20, 2008)
Overview of comments received on EMEA's draft guideline on virus safety evaluation of investigational biologics.

Product documentation (October 20, 2008)
Myozyme: Briefing documents for the Oct. 21 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss a BLA for Myozyme alglucosidase alfa produced at a 2,000-liter bioreactor scale to treat late-onset Pompe's disease, from Genzyme Corp. (NASDAQ:GENZ) (see BioCentury, Friday, Oct. 17).
Orplatna: EMEA Q&A on the withdrawal of an MAA for Orplatna satraplatin plus prednisone to treat hormone-refractor prostate cancer (HRPC) in patients who have failed prior chemotherapy, from Celgene Corp. (NASDAQ:CELG) and GPC Biotech AG (Xetra:GPC; NASDAQ:GPCB). (PDF file)
Tyverb: NICE's second preliminary appraisal recommending against the use of Tyverb lapatinib in combination with capecitabine to treat advanced or metastatic breast cancer patients whose tumors overexpress HER2, except in clinical trials, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Tuesday, Oct. 14).

Cell/Gene therapy (PDF file) (October 13, 2008)
Draft FDA guidance on the development of potency tests for cellular and gene therapy products (see BioCentury Extra, Thursday, Oct. 9).

Conflict of interest (PDF file) (October 13, 2008)
U.S. Government Accountability Office (GAO) report on FDA's process for recruiting members of advisory committees and the evaluation of potential conflicts of interest.

Contrast Imaging (PDF file) (October 13, 2008)
Draft FDA guidance on new contrast imaging indication considerations for devices and approved drug and biological products.

Diabetes (PDF file) (October 13, 2008)
Draft NICE guidance on the use of newer agents for blood glucose control in adults with Type II diabetes.

Orphan drugs(PDF file) (October 13, 2008)
Summary of actions taken at the Oct. 6-7 plenary meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Regulatory cooperation (PDF file) (October 13, 2008)
Joint statement by EC, EMEA and FDA confirming the planned expansion of cooperation in the areas of advanced-therapy and nanotechnology-derived medical products, as well as the exchange of pharmacovigilance information.

Radiopharmaceuticals (PDF file) (October 6, 2008)
EMEA public statement on the shortage of radiopharmaceuticals.

Product documentation (October 6, 2008)
Biograstim: CHMP EPAR for Biograstim filgrastim to treat neutropenia, from CT Arzneimittel GmbH. The biologic is a biosimilar of Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN).
Bridion: CHMP EPAR for Bridion sugammadex for the reversal of neuromuscular blockade induced by rocuronium or vecuronium, from Schering-Plough Corp. (NYSE:SGP).
Copaxone: Citizen's Petition submitted to FDA by Teva Pharmaceuticals Industries Ltd. (NASDAQ:TEVA) seeking to halt approval of a generic version of the company's Copaxone glatiramer to treat multiple sclerosis (MS). Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) and the Sandoz unit of Novartis AG (NYSE:NVS; SWX:NOVN) have submitted an ANDA for a generic glatiramer (see BioCentury Extra, Thursday, Oct. 2). (PDF file)
Erbitux: NICE preliminary appraisal recommending against the use of Erbitux cetuximab for first-line treatment of colorectal cancer, from Merck KGaA (Xetra:MRK). ImClone Systems Inc. (NASDAQ:IMCL) and Bristol-Myers Squibb Co. (NYSE:BMY) market the drug in North America (see BioCentury Extra, Friday, Sept. 26).
Filgrastim ratiopharm: CHMP EPAR for Filgrastim ratiopharm to treat neutropenia, from ratiopharm GmbH. The biologic is a biosimilar of Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN).
Ratiograstim: CHMP EPAR for Ratiograstim filgrastim to treat neutropenia, from ratiopharm GmbH. The biologic is a biosimilar of Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN).
Raptiva: Dear Healthcare Professional letter warning of progressive multifocal leukoencephalopathy (PML) in a patient receiving Raptiva efalizumab to treat moderate to severe chronic plaque psoriasis, from Genentech Inc. (NYSE:DNA) (see BioCentury Extra, Thursday, Oct. 2). (PDF file)
Sutent: CHMP updated EPAR to include nephrotic syndrome and proteinuria, thrombotic microangiopathy and hyperthyroidism as adverse reactions, and added information regarding QT interval prolongation for Sutent sunitinib to treat unresectable and/or metastatic malignant gastrointestinal stromal tumor (GIST) after failure of imatinib mesylate, and to treat advanced and/or metastatic renal cell carcinoma (RCC), from Pfizer Inc. (NYSE:PFE). (PDF file)
Tamiflu: CHMP revised EPAR updating the SPC and package leaflet to include visual disturbances and cardiac arrhythmia as undesirable effects of Tamiflu oseltamivir to treat and prevent influenza, from Roche (SWX:ROG) and Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)
Tarceva: NICE final appraisal determination recommending use of Tarceva erlotinib as second-line treatment of non-small cell lung cancer (NSCLC) when overall treatment costs of the drug is the same as those of docetaxel, from Roche (SWX:ROG) (see BioCentury Extra, Monday, Sept. 29). (PDF file)
Tevagrastim: CHMP EPAR for Tevagrastim filgrastim to treat neutropenia, from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). The biologic is a biosimilar of Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN).
Viread: CHMP updated EPAR to indicate that bone abnormalities associated with proximal renal tubulopathy may infrequently contribute to fractures and to include reported cases of hypokalemia and hepatic steatosis in patients receiving Viread tenofovir disoproxil fumarate to treat HIV-1 in combination with other antiretrovirals and HBV, from Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)

ADHD (PDF file) (September 29, 2008)
NICE clinical guideline for diagnosing and managing attention deficit hyperactivity disorder (ADHD).

Chronic kidney disease (PDF file) (September 29, 2008)
NICE clinical guideline on early identification and management of CKD in adults in primary and secondary care.

FDAAA (September 29, 2008)
� FDA action deadlines for implementing the Food and Drug Administration Amendments Act of 2007 (see " FDA Triages its New Powers").
� The list of 16 drugs identified by FDA as requiring a proposed risk evaluation and mitigation strategy (REMS) for drugs now marketed under voluntary RiskMaps. (PDF file)

Influenza (PDF file) (September 29, 2008)
NICE's final guidance recommending use of Tamiflu oseltamivir from Roche (SWX:ROG) and Gilead Sciences Inc. (NASDAQ:GILD) and Relenza zanamivir from Biota Holdings Ltd. (ASX:BTA) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for post-exposure prophylaxis of influenza under defined conditions.

Net operating losses (PDF file) (September 29, 2008)
Text of California Assembly Bill No. 1452, which includes provisions allowing unprofitable companies to carry over NOLs forward for 20 years, instead of for 10 years (see "NOL Juggling").Pediatric drugs (PDF file) (September 29, 2008)
Summary of actions taken at the Sept. 17-19 meeting of EMEA's Pediatric Committee (PDCO).

Product Documentation (PDF files) (September 29, 2008)
Adrovance/Fosavance: CHMP revised EPAR updating the SPC and package leaflet to include alopecia as a possible side effect for Adrovance/Fosavance alendronate to treat postmenopausal osteoporosis in patients at risk of vitamin D deficiency, from Merck & Co. Inc. (NYSE:MRK) and Ipsen Group (Euronext:IPN).
Cancidas: CHMP summary of a positive opinion to expand the label of Cancidas caspofungin to include the treatment of indicated fungal infections in pediatric patients, from Merck & Co. Inc. (NYSE:MRK).
Lantus: CHMP revised EPAR updating the SPC with data on the effects of Lantus insulin glargine on progression of diabetic retinopathy in Type II diabetics, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Pradaxa: NICE's final guidance recommending Pradaxa dabigatran etexilate for preventing venous thromboembolism in adults who have undergone elective total hip or total knee replacement surgery, from Boehringer Ingelheim GmbH.
Tysabri: EMEA recommendation to update product information to increase awareness about the risk of progressive multifocal leukoencephalopathy (PML) from use of Tysabri natalizumab to treat relapsing-remitting multiple sclerosis (RRMS), from Biogen Idec Inc. (NASDAQ:BIIB) and Elan Corp. plc (NYSE:ELN).
Zostavax: CHMP revised EPAR updating the SPC and package leaflet to include pyrexia and hypersensitivity reactions including anaphylactic reactions and rashes as side effects for patients taking Zostavax to prevent herpes zoster and related post-herpetic neuralgia, from Merck & Co. Inc. (NYSE:MRK) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY).

Crohn’s disease (September 22, 2008)
NICE preliminary appraisal recommending against the use of Humira adalimumab from Abbott Laboratories (NYSE:ABT) and Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP) as regular maintenance treatment to prevent relapse of Crohn's disease (see BioCentury Extra, Wednesday, Sept. 17).

Genetic engineering (PDF file) (September 22, 2008)
FDA draft guidance on the regulation of genetically engineered animals containing heritable rDNA constructs.

Pediatrics (PDF file) (September 22, 2008)
EMEA decision to grant a waiver to the class of peroxisome proliferation activated receptor (PPAR) gamma modulators to treat Type II diabetes mellitus in all pediatric groups.

Short selling (September 22, 2008)
New U.S. Securities and Exchange Commission (SEC) rules to eliminate "naked" short selling (see BioCentury, September 22).

Product documentation (September 22, 2008)
Diractin: EMEA Q&A on the withdrawal of an MAA for Diractin ketoprofen to treat inflammation and pain associated with osteoarthritis, from Idea AG and Alpharma Inc. (NYSE:ALO). (PDF file)
Velcade: CHMP revised EPAR to add the new indication for Velcade bortezomib in combination with melphalan and prednisone to treat previously untreated multiple myeloma (MM) in patients who are not eligible for high-dose chemotherapy with bone marrow transplant, from Johnson & Johnson (NYSE:JNJ) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). (PDF file)
Vimpat: CHMP EPAR on Vimpat lacosamide an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in epilepsy patients aged 16 or older, from UCB Group (Euronext:UCB) (see BioCentury Extra, Wednesday, Sept. 3).

EU research funds (PDF file) (September 15, 2008)
EC guide to EU funding opportunities for research and innovation.

Manufacturing (PDF file) (September 15, 2008)
FDA final rule amending certain regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals.

NICE (PDF file) (September 15, 2008)
NICE 2007-08 annual report (see BioCentury Extra, Wednesday, Sept. 10).

Orphan drugs (PDF file) (September 15, 2008)
Summary of actions taken at the Sept. 9-10 plenary meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Vaccines (September 15, 2008)
Notice of a Sept. 25 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss the use of Madin-Darby canine kidney (MDCK) cells for manufacture of live attenuated influenza virus vaccines.

Product documentation (PDF files) (September 15, 2008)
Actemra: Transcripts from the July 29 meeting of FDA's Arthritis Drugs Advisory Committee to discuss a BLA for Actemra tocilizumab to treat moderate-to-severe rheumatoid arthritis (RA), from Roche (SWX:ROG) (see BioCentury, Aug. 4).
Champix: CHMP revised EPAR updating the SPC and package leaflet to strengthen wording regarding suicide-related events for patients taking Champix varenicline for smoking cessation, from Pfizer Inc. (NYSE:PFE).
Gardasil/Silgard: CHMP revised EPAR updating the SPC and package leaflet to include cross protection data against HPV types not specifically targeted by Gardasil/Silgard to prevent cervical cancer, precancerous or dysplastic lesions and genital warts caused by HPV types 6, 11, 16 and 18, from Merck & Co. Inc. (NYSE:MRK) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Friday, Sept. 12).
Kivexa: CHMP revised EPAR updating the SPC and package leaflet to warn that patients carrying the HLA-B*5701 allele should not use Kivexa abacavir/lamivudine to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
ProQuad: CHMP revised EPAR updating the SPC and package leaflet to add epididymitis as an adverse event for ProQuad for vaccination against measles, mumps, rubella and varicella viruses, from Merck & Co. Inc. (NYSE:MRK) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Tequin: FDA determination that Tequin gatifloxacin for bacterial infections was withdrawn from sale for reasons of safety or effectiveness, from Bristol-Myers Squibb Co. (NYSE:BMY).
Viramune: CHMP revised EPAR updating the SPC to state that there is no evidence of teratogenic effects for Viramune nevirapine to treat HIV infection, from Boehringer Ingelheim GmbH.

Alzheimer's disease (PDF file) (September 8, 2008)
EMEA guideline on developing medicinal products to treat AD and other dementias (see BioCentury Extra, Friday, Sept. 5).

Anti-arrhythmics (PDF file) (September 8, 2008)
EMEA draft addendum on atrial fibrillation for a note for guidance on anti-arrhythmics.

Bioequivalence (PDF file) (September 8, 2008)
FDA draft guidance on bioequivalence recommendations for certain products to support an ANDA.

Crohn's disease (PDf file) (September 8, 2008)
EMEA guideline for developing medicinal products to treat Crohn's disease.

Immunosuppressants (PDF file) (September 8, 2008)
EMEA guideline for developing immunosuppressants to prevent and treat allograft rejection in solid organ transplantation.

Parkinson's disease (PDF file) (September 8, 2008)
EMEA guideline for developing medicinal products to treat Parkinson's disease (see BioCentury Extra, Friday, Sept. 5).

Pediatrics (PDF file) (September 8, 2008)
EMEA updated FAQ regarding pediatric regulations for MAA submissions.

Tuberculosis (September 8, 2008)
Special issue of Tuberculosis Reviews on TB drug research and development, as commissioned by TB Alliance (see Cover Story).

Weight control (PDF file) (September 8, 2008)
EMEA addendum on weight control in children to the guideline for developing medicinal products for weight control.

Product documentation (September 8, 2008)
Abilify: CHMP revised EPAR updating the SPC to include information on risk of suicidality in patients with bipolar disorder receiving Abilify aripiprazole to treat schizophrenia and manic episodes in bipolar I disorder, from Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768) and Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Intelence: CHMP EPAR for Intelence etravirine to treat HIV-1 infection in antiretroviral treatment-experienced adults when used in combination with other antiretroviral agents, from Johnson & Johnson (NYSE:JNJ).
Fablyn: Briefing documents for the Sept. 8 meeting of FDA's Reproductive Health Drugs Advisory Committee to discuss an NDA for Fablyn lasofoxifene to treat osteoporosis in postmenopausal women, from Pfizer Inc. (NYSE:PFE) and Ligand Pharmaceuticals Inc. (NASDAQ:LGND) (see BioCentury Extra, Thursday, Sept. 4).
Spanidin: EMEA withdrawal assessment report for Spanidin gusperimus to treat refractory Wegener's granulomatosis, from Nippon Kayaku Co. Ltd. (PDF file)

Hypercholesterolemia (September 1, 2008)
NICE clinical guideline covering the identification and management of familial hypercholesterolemia (see BioCentury Extra, Friday, Aug. 29).

Regulatory submissions (PDF file) (September 1, 2008)
FDA draft guidance on preparation of an integrated summary of effectiveness for NDAs and BLAs.

Product documentation (September 1, 2008)
Baraclude: NICE's final guidance recommending Baraclude entecavir to treat chronic HBV patients who are hepatitis B e antigen (HbeAG)-positive and HbeAG-negative, from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Wednesday Aug. 27). (PDF file)
Cervarix: CHMP revised EPAR updating the SPC to include long-term follow-up data showing duration of persistence of the immune response to infections with types HPV-16 and HPV-18 for Cervarix to prevent precancerous lesions and cervical cancer caused by HPV-16 and HPV-18, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Cholestagel: CHMP revised EPAR updating the SPC to include data from a study of Cholestagel colesevelam co-administered with fenofibrate to treat hyperlipidemia, from Genzyme Corp. (NASDAQ:GENZ) and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568). (PDF file)
Lucentis: NICE's final guidance recommending the use of Lucentis ranibizumab for eligible patients to treat wet age-related macular degeneration (AMD), from Novartis AG (NYSE:NVS; SWX:NOVN) and Genentech Inc. (NYSE:DNA) (see BioCentury Extra, Wednesday Aug. 27). (PDF file)
Macugen: NICE's final guidance recommending against the use of Macugen pegaptanib to treat wet age-related macular degeneration (AMD), from OSI Pharmaceuticals Inc. (NASDAQ:OSIP) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Wednesday Aug. 27). (PDF file)
Mimpara: CHMP revised EPAR updating the SPC and package leaflet to expand the label to include reduction of hypercalcemia in patients with primary hyperparathyroidism (HPT) for Mimpara cinacalcet, from Amgen Inc. (NASDAQ:AMGN) and NPS Pharmaceuticals Inc. (NASDAQ:NPSP). (PDF file)
Sebivo: NICE's final guidance recommending against the use of Sebivo telbivudine to treat chronic HBV, from Novartis AG (NYSE:NVS; SWX:NOVN) and Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) (see BioCentury Extra, Wednesday Aug. 27). (PDF file)

Conflict of interest (August 25, 2008)
Journal of the American Medical Association (JAMA) "Principles Governing Advertising in Publications of the American Medical Association." (see "Sacred vs. Profane").

Labeling (PDF file) (August 25, 2008)
FDA final rule that would permit sponsors to amend labels in advance of the agency's review and approval to include a safety signal "only if there is sufficient evidence of a causal association with the drug, biologic, or medical device" (see BioCentury Extra, Friday, Aug. 22).

Product documentation (PDF files) (August 25, 2008)
Acomplia: CHMP revised EPAR updating the SPC and package leaflet to add depression, hypoglycemia, tremor, psychotic disorders, rash, convulsions, disturbance in attention, headache and abdominal pain as adverse events for patients receiving Acomplia rimonabant to treat obesity, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Adenuric: NICE final appraisal recommending Adenuric febuxostat to manage chronic hyperuricemia in gout for patients who are intolerant of or have a contraindication to allopurinol, from Ipsen Group (Euronext:IPN) (see BioCentury Extra, Monday, Aug. 18).
Cubicin: CHMP revised EPAR updating the SPC to strengthen warnings on clinical failures that have occurred with Cubicin daptomycin for the off-label treatment of enterococcal infections, from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) and Novartis AG (NYSE:NVS; SWX:NOVN).
Fabrazyme: CHMP annual assessment concluding that an MAA for Fabrazyme agalsidase beta to treat Fabry's disease no longer has to remain under exceptional circumstances, from Genzyme Corp. (NASDAQ:GENZ).
Levitra: CHMP revised EPAR updating the SPC to include information about the possible effects on QT interval for patients taking Levitra vardenafil to treat erectile dysfunction (ED), from Bayer AG (Xetra:BAY), GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Schering-Plough Corp. (NYSE:SGP).
Pegasys: CHMP revised EPAR updating the SPC and package leaflet to include fungal, bacterial and viral infections, cerebral ischemia, serious retinal detachment, cardiomyopathy, vasculitis, rhabdomyolysis and renal insufficiency as adverse reactions for Pegasys peginterferon alfa-2a to treat chronic HBV and HCV, from Roche (SWX:ROG).
Revlimid: CHMP revised EPAR updating the SPC, labeling and package leaflet with preclinical safety data showing teratogenic effects in monkeys for Revlimid lenalidomide to treat multiple myeloma, from Celgene Corp. (NASDAQ:CELG).
Vectibix: CHMP revised EPAR updating the SPC and package leaflet to include pulmonary embolism as an adverse reaction for patients taking Vectibix panitumumab to treat metastatic colorectal cancer, from Amgen Inc. (NASDAQ:AMGN).
Zyprexa: CHMP revised EPAR updating the SPC to include data regarding clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol and triglycerides levels over time in patients taking Zyprexa olanzapine to treat schizophrenia, from Eli Lilly and Co. (NYSE:LLY).

Corporate disclosure (August 18, 2008)
Text of the Massachusetts Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care (see “Tough Love?”).

Suicidality (PDF file) (August 18, 2008)
Transcript of the July 10 meeting of FDA's Peripheral and Central Nervous System Drugs and Psychopharmacologic Drugs advisory committees to discuss the agency's analysis of suicidality from clinical studies of 11 drugs (see BioCentury, July 14).

Transgenic plants (PDF file) (August 18, 2008)
EMEA guidance on the use of transgenic plant technology to produce biological active substances.

Virus safety (PDF file) (August 18, 2008)
EMEA guidance relating to the viral safety of biotechnological medicinal products in clinical trials.

Product documentation (August 18, 2008)
Myfenax: CHMP revised EPAR updating the SPC and package leaflet to include information that cases of progressive multifocal leukoencephalopathy (PML) and spontaneous abortion in patients receiving Myfenax mycophenolate mofetil to prevent acute transplant rejection, from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). (PDF file)
Remicade: NICE preliminary appraisal recommending use of Remicade infliximab to treat acute exacerbations of severely active ulcerative colitis (UC) when cyclosporin is contraindicated, from Johnson & Johnson (NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP) (see BioCentury Extra, Wednesday, Aug. 13).
Rotarix: CHMP revised EPAR updating the SPC and package leaflet to include efficacy data from the second-year follow-up from a clinical study of Rotarix oral attenuated rotavirus vaccine to prevent gastroenteritis due to rotavirus infection in children, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Avant Immunotherapeutics Inc. (NASDAQ:AVAN). (PDF file)

Advisory committees(PDF files) (August 11, 2008)
� FDA draft guidance on factors the agency considers in deciding whether to refer a matter to an advisory committee for consideration.
� FDA guidance on the preparation and public availability of the information given to advisory committee members.
� FDA guidance on voting procedures for advisory committee meetings.
� FDA guidance on public availability of advisory committee members' financial interest information and waivers.
� FDA guidance on procedures for determining a conflict of interest and eligibility for participating in advisory committees.

Biosimilars (PDF file) (August 11, 2008)
EMEA concept paper recommending revised guidance on similar biological medicinal products containing recombinant erythropoietins.

Genotoxicity (PDF file) (August 11, 2008)
EMEA Q&A on the CHMP guideline on the limits of genotoxic impurities.

Guidances (August 11, 2008)
� EMEA's new website space devoted to regulatory and procedure guidance.
� FDA agenda of guidance documents under development for 2009. (PDF file)

MAAs (PDF file) (August 11, 2008)
EMEA guidance on the time allowed for applicants to respond to questions and issues raised during the assessment of new MAAs in the centralized procedure.

Manufacturing (PDF file) (August 11, 2008)
FDA draft guidance on the control of residual solvents in drug products marketed in the U.S.

Nanotechnology (PDF file) (August 11, 2008)
Notice of a Sept. 8 public meeting to discuss FDA-regulated products containing nanoscale materials.

Pediatric Drugs (PDF files) (August 11, 2008)
� EMEA concept paper on developing a guideline for the development of medicines for pediatric use.
� EMEA decision on a review of pediatric class waivers.
Summary of actions taken at the July 29-31 meeting of EMEA's Pediatric Committee (PDCO).

Renal cell carcinoma (August 11, 2008)
NICE preliminary guidance recommending against the use of Avastin bevacizumab from Roche (SWX:ROG), Nexavar sorafenib from Bayer AG (Xetra:BAY), Sutent sunitinib from Pfizer Inc. (NYSE:PFE) and Torisel temsirolimus from Wyeth (NYSE:WYE) to treat renal cell carcinoma (RCC) (see "New Losers in U.K.'s Zero Sum Game").

Pregnancy (PDF file) (August 11, 2008)
EMEA guideline on risk assessment of medicinal products on human reproduction and lactation.

Toxicity (PDF file) (August 11, 2008)
EMEA concept paper recommending revised guidelines for acute toxicity studies.

Product documentation (August 11, 2008)
Doribax: CHMP EPAR for Doribax doripenem to treat nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections, from Johnson & Johnson (NYSE:JNJ) and Shionogi & Co. Ltd.
Tygacil: EMEA withdrawal assessment report for Tygacil tigecycline to treat community-acquired pneumonia (CAP), from Wyeth (NYSE:WYE). (PDF file)
Zavesca: EMEA withdrawal assessment report for Zavesca miglustat to treat Niemann-Pick type C disease, from Actelion Ltd. (SWX:ATLN) and UCB Group (Euronext:UCB). (PDF file)

CHMP (PDF file) (August 4, 2008)
Detailed report of actions taken at EMEA's CHMP plenary meeting July 21-24.

CMS (August 4, 2008)
Centers for Medicare & Medicaid Services (CMS) list of topics to consider for National Coverage Determination (NCD) (see BioCentury Extra, Friday, Aug. 1).

Comparative effectiveness (PDF file) (August 4, 2008)
Text of the Comparative Effectiveness Research Act of 2008, which seeks to establish a national research institute that would compare the effectiveness of medical treatments (see BioCentury Extra, Friday, Aug. 1).

Economic aid (PDF file) (August 4, 2008)
Text of the Housing and Economic Recovery Act of 2008, which includes a provision that would allow a refund related to capital investments made between March 31 and Dec. 31, 2008 (see BioCentury Extra, Wednesday, July 30).

ESAs (August 4, 2008)
FDA revisions to labels for erthryopoiesis-stimulating agents to exclude their use in treating anemia associated with chemotherapy in patients being treated for cancer with the anticipation of cure (see "FDA the Enforcer").

INDs (PDF file) (August 4, 2008)
FDA draft guidance on completing the Statement of Investigator form (Form FDA 1572) for clinical trials conducted under an IND.

PDUFA (August 4, 2008)
� FDA notice on the prescription drug user fee rates collected under PDUFA for fiscal year 2009. (PDF file)

Plasma-derived products (PDF file) (August 4, 2008)
FDA draft guidance on nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products.

Safety (PDF file) (August 4, 2008)
EMEA draft guidance on non-clinical safety studies to support human clinical trials and marketing authorization of pharmaceuticals.

Product documentation (August 4, 2008)
DuoPlavin: EMEA withdrawal assessment report for DuoPlavin clopidogrel/acetylsalicylic acid to prevent atherothrombotic events in acute coronary syndrome (ACS), from Bristol-Myers Squibb Co. (NYSE:BMY) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Tuesday, May 27). (PDF file)
Janumet: CHMP EPAR for Janumet sitagliptin/metformin to treat Type II diabetes, from Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Monday, July 21).
Revlimid/Lenalidomide Celgene Europe: EMEA withdrawal assessment report on Revlimid/Lenalidomide Celegene Europe lenalidomide to treat myelodysplastic syndromes (MDS), from Celgene Corp. (NASDAQ:CELG).

Antibiotics (July 28, 2008)
Website of the Infectious Diseases Society of America, containing a letter to the FDA Commissioner asking the agency to support the creation of incentives for antibacterial drug development and for clarification on the agency's views on the applicability of the Orphan Drug Act to anti-microbial drugs (see BioCentury Extra, Thursday, July 24).

Diabetes (PDF files) (July 28, 2008)
� NICE technology appraisal on continuous subcutaneous insulin infusion to treat diabetes mellitus.

Drug-eluting stents (PDF file) (July 28, 2008)
NICE technology appraisal on drug-eluting stents for the treatment of coronary artery disease (CAD).

Electronic Submissions (PDF file) (July 28, 2008)
EMEA Q&A on technical and practical aspects of the agency's plans to implement electronic-only, and specifically electronic Common Technical Document (eCTD)-only, submission for the centralized procedure.

EMEA (PDF file) (July 28, 2008)
EMEA schedule of meetings for 2009.

Manufacturing (PDF file) (July 28, 2008)
EMEA outline for a project to rationalize international good manufacturing practices (GMP) inspection activities.

Product Documentation (July 28, 2008)
Actemra: Briefing documents for the July 29 meeting of FDA's Arthritis Advisory Committee to review a BLA for Actemra tocilizumab to treat moderate to severe rheumatoid arthritis (RA), from Roche (SWX:ROG) (see BioCentury Extra, Friday, July 25).
Aldara: CHMP revised EPAR updating the SPC with pediatric data of Aldara imiquimod in children with molluscum contagiosum, from Meda AB (SSE:MEDA). (PDF file)
Aquilda: CHMP withdrawal assessment report on the agency's decision that the MAA for Aquilda satavaptan is not approvable for the treatment of euvolemic and hypervolemic dilutional hyponatremia, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
� Ceplene: CHMP positive opinion and Q&A for an MAA for Ceplene histamine in combination with interleukin-2 (IL-2) to maintain remission in patients with acute myelogenous leukemia (AML), from EpiCept Corp. (NASDAQ:EPCT; SSE:EPCT). (PDF files)
Evicel: CHMP summary of opinion recommending approval of Evicel human fibrinogen and thrombin for sealant intended for use as supportive treatment in surgery, from Omrix Biopharmaceuticals Inc. (NASDAQ:OMRI). (PDF file)
Firazyr: CHMP EPAR for Firazyr icatibant to treat acute attacks of hereditary angioedema (HAE), from Jerini AG (Xetra:JI4) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Renagel: CHMP revised EPAR updating the SPC and package leaflet to remove headache, hypotension, hypertension, pain, pruritis, rash and pharyngitis from the list of adverse events for patients receiving Renagel sevelamer to treat hyperphosphatemia, from Genzyme Corp. (NASDAQ:GENZ). (PDF file)
Sovrima: CHMP Q&A on its negative opinion for an MAA for Sovrima idebenone to treat Friedreich's ataxia, from Santhera Pharmaceuticals Holding AG (SWX:SANN). (PDF file)
Vistide: CHMP revised EPAR updating the SPC and package leaflet to include safety information for Vistide cidofovir co-administered with probenecid to treat cytomegalovirus (CMV) retinitis in patients with AIDS, from Gilead Sciences Inc. (NASDAQ:GILD) and Pfizer Inc. (NYSE:PFE). (PDF file)
Xarelto: CHMP summary of opinion recommending approval of Xarelto rivaroxaban to prevent venous thromboembolism (VE) in patients undergoing hip or knee replacement surgery, from Bayer AG (Xetra:BAY) and Johnson & Johnson (NYSE:JNJ). (PDF file)
Zometa: CHMP revised EPAR updating the SPC and package leaflet to add postmarketing experiences of anaphylactic reaction/shock and urticaria in patients receiving Zometa zoledronic acid to treat bone metastases and bone complications in cancer patients, from Novartis AG (NYSE:NVS; SWX:NOVN). (PDF file)
Zyprexa: CHMP revised EPAR updating the SPC and package leaflet to include data from trials in adolescents of Zyprexa olanzapine to treat schizophrenia and bipolar I disorder, from Eli Lilly and Co. (NYSE:LLY). (PDF file)

Antibiotics (PDF file) (July 21, 2008)
EMEA concept paper on the development of a guideline on setting specifications for related impurities in antibiotics.

Formulation (PDF file) (July 21, 2008)
Briefing documents for the July 22-23 meeting of the FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss nanotechnology in drug manufacturing, drug delivery and drug products; lead-in pharmaceutical products; bioequivalence methods for drugs to treat gastrointestinal (GI) conditions; drug classification of orally disintegrating tablets (ODT); and use of inhaled corticosteroid dose response as a means to establish bioequivalence of inhaled drugs.

FDA (July 21, 2008)
Information on the FDA Commissioner's Fellowship Program, a two-year fellowship program to attract scientists, engineers and health professionals to the agency (see BioCentury Extra, Friday, July 18).

Hematology (July 21, 2008)
Briefing Documents for the July 18 meeting of the FDA's Hematology and Pathology Devices panel on complete blood count and differential cell count assays performed by laboratories under the CLIA waiver process.

IV Immune Globulin (PDF file) (July 21, 2008)
FDA final guidance for safety, efficacy and pharmacokinetic testing of immune globulin intravenous (IGIV) products to support a BLA for replacement therapy for primary humoral immunodeficiency.

Manufacturing (PDF files) (July 21, 2008)
� FDA final rules amending the current regulations to exempt most Phase I compounds from complying with CGMP requirements.

Mycoplasma (PDF file) (July 21, 2008)
FDA notice of a public workshop on Sept. 22-23 to discuss rapid methods for detecting mycoplasma contamination in the manufacture of vaccines, including pandemic influenza vaccines, and other biologics.

NICE (PDF file) (July 21, 2008)
Report of the NICE Citizens' Council, which voted 24-2 that the agency and its advisory bodies should take the severity of a disease into account when making decisions about whether drugs should be recommended for coverage by NHS (see BioCentury Extra, Friday, July 18).

Radiation Syndrome (PDF file) (July 21, 2008)
FDA notice of a public workshop on Sept. 17-18 to discuss animal models to treat acute radiation syndrome.

Patents (PDF file) (July 21, 2008)
Description of the Triway joint program of the U.S. Patent and Trademark Office, the European Patent Office and the Japan Patent Office to reduce the prior art search and examination workload for each office (see BioCentury Extra, Wednesday, July 16).

Product documentation (July 21, 2008)
Aptivus: CHMP revised EPAR updating the SPC and package leaflet with results from preclinical studies for tipranavir-related effects on coagulation parameters and to advise caution for the co-administration of high doses of vitamin E and Aptivus tipranavir to treat HIV infection, from Boehringer Ingelheim GmbH. (PDF file)
Avastin: Dear Healthcare Professional letter warning of microangiopathic hemolytic anemia in patients receiving Avastin bevacizumab in combination with sunitinib malate to treat colorectal, breast and non-small cell lung cancers, from Genentech Inc. (NYSE:DNA) and Roche (SWX:ROG). (PDF file)
Doribax: Briefing documents for the July 16 meeting of the FDA Anti-Infective Drugs Advisory Committee, which voted 7-6 to recommend approval of Doribax doripenem to treat nosocomial pneumonia (NP), from Johnson & Johnson (NYSE:JNJ) (see Cover Story).
Kaletra: CHMP revised EPAR updating the SPC and package leaflet with information on the potential for QTc and PR interval prolongation based on the results from a clinical study in volunteers receiving Kaletra lopinavir/ritonavir to treat HIV infection, from Abbott Laboratories (NYSE:ABT). (PDF file)
NutroinAq: CHMP revised EPAR updating the SPC and package leaflet to add a warning on aseptic necrosis in children with advanced renal osteodystrophy and with growth hormone deficiency receiving NutroinAq somatropin to treat growth failure, from Ipsen Group (Euronext:IPN). (PDF file)
Optison: EMEA public statement on the withdrawal of marketing authorization of Optison perflutren for use as a contrast agent in diagnostic imaging, from General Electric Co. (NYSE:GE). (PDF file)
Temodal: CHMP revised EPAR updating the SPC and package leaflet with information on cases of myelodysplastic syndrome (MDS) and secondary malignancies, including myeloid leukemia, in patients receiving Temodal temozolomide to treat glioblastoma multiforme (GBM), from Schering-Plough Corp. (NYSE:SGP). (PDF file)
Tesavel: CHMP revised EPAR updating the SPC regarding hypersensitivity reactions for Tesavel sitagliptin to treat Type II diabetes in combination with a peroxisome proliferation activated receptor (PPAR) gamma agonist, metformin, sulfonylurea, or metformin plus sulfonylurea, from Merck & Co. Inc. (NYSE:MRK). (PDF file)

Antidepressants (July 14, 2008)
CHMP opinion and assessment report on the approval process for antidepressants.

Antiepileptic drugs (July 14, 2008)
Briefing documents for the July 10 meeting of FDA's Peripheral and Central Nervous System Drugs and Psycopharmacologic Drugs advisory committees to review how the agency should structure warnings about the risk of suicidality associated with epilepsy drugs (see "Presumption of Guilt").

Dyslipidemia (PDF file) (July 14, 2008)
American Academy of Pediatrics (AAP) report lowering the age at which pharmacologic intervention for dyslipidemia is recommended to 8 years of age from 10 (see BioCentury Extra, Monday, July 7).

Electronic submissions (PDF file) (July 14, 2008)
FDA draft guidance on how manufacturers can electronically submit drug establishment registration and drug listing information.

Orphan drugs (PDF file) (July 14, 2008)
Summary of actions taken at the July 8-9 plenary meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Pediatric drugs (PDF file) (July 14, 2008)
Summary of actions taken at the July 2-4 meeting of EMEA's Pediatric Committee (PDCO).

Pharmacovigilance (PDF file) (July 14, 2008)
EMEA guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system.

Regulatory approval (PDF file) (July 14, 2008)
FDA final rule that replaces "approvable" and "not approvable" letters when a drug application is not approved with a "complete response" letter (see BioCentury Extra, Wednesday, July 9).

Product Documentation (July 14, 2008)
orBec: CHMP withdrawal assessment report on the agency's decision that the MAA for orBec beclomethasone dipropionate is not approvable for the treatment of gastrointestinal graft-versus-host disease (GvHD), from Dor BioPharma Inc. (OTCBB:DORB). (PDF file)
Rapamune: CHMP revised EPAR updating the SPC and package leaflet to include results from a study evaluating the pharmacokinetics of Rapamune sirolimus in patients with severe hepatic impairment to prevent organ rejection in renal transplantation, from Wyeth (NYSE:WYE). (PDF file)
Tarceva: NICE preliminary appraisal recommending the use of Tarceva erlotinib as an alternative to docetaxel as a second-line treatment of non-small cell lung cancer (NSCLC) only when overall treatment costs of Tarceva are the same as those of docetaxel, and recommending against the use as second-line treatment of locally advanced or metastatic NSCLC in patients for whom docetaxel is unsuitable or for third-line treatment after docetaxel, from Roche (SWX:ROG) (see BioCentury Extra, Monday, July 7).
Twinrix: CHMP revised EPAR updating the SPC and package leaflet to include information on the effect of obesity on the immune response in patients receiving Twinrix vaccine to prevent hepatitis A and B, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Tyverb: NICE preliminary appraisal recommending against the use of Tyverb lapatinib in combination with capecitabine to treat advanced or metastatic breast cancer patients whose tumors overexpress HER2, except in clinical trials, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Monday, July 7).
Viracept: CHMP revised EPAR updating the SPC with safety information in pediatric population for Viracept nelfinavir to treat HIV infection, from Roche (SWX:ROG) and Pfizer Inc. (NYSE:PFE).

CHMP (PDF file) (July 7, 2008)
Detailed report of actions taken at EMEA's CHMP plenary meeting June 23-26.

PDUFA (PDF file) (July 7, 2008)
FDA plan to guide direction and implementation of IT projects initiated to meet the objectives set out in PDUFA IV.

Preemption (PDF file) (July 7, 2008)
Text of the proposed Medical Device Safety Act of 2008 (H.R. 6381), which would allow patients to seek compensation for injury from device manufacturers under state tort laws (see BioCentury Extra, Monday, June 30).

Manufacturing (PDF file) (July 7, 2008)
FDA notice of pilot program assist the agency in developing guidance on quality by design and risk management in pharmaceutical manufacturing.

Product documentation (PDF files) (July 7, 2008)
Aflunov: EMEA Q&A on the withdrawal of the MAA for Aflunov H5N1 pre-pandemic influenza vaccine to prevent H5N1 influenza infection, from Novartis AG (NYSE:NVS; SWX:NOVN).
Lenalidomide-Celgene Europe: EMEA Q&A on the withdrawal of the MAA for Lenalidomide-Celgene Europe (Revlimid-U.S.) to treat transfusion-dependent anemia due to myelodysplastic syndromes (MDS) with 5q chromosomal deletion, from Celgene Corp. (NASDAQ:CELG).
Spanidin: EMEA Q&A on the withdrawal of the MAA for Spanidin gusperimus to treat refractory Wegener's granulomatosis, from Nippon Kayaku Co. Ltd. (Tokyo:4272).

CHMP (PDF file) (June 30, 2008)
Summary of actions taken at CHMP's June plenary meeting.

Diabetes (PDF file) (June 30, 2008)
Briefing documents for the July 1-2 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss whether long-term cardiovascular trials should be part of the approval process for drugs or biologics to treat Type II diabetes (see BioCentury Extra, Friday, June 27).

Electronic Submissions (PDF file) (June 30, 2008)
EMEA Q&A on the agency's plans to implement electronic-only submission for the Centralized Procedure.

FOBs (PDF file) (June 30, 2008)
A cost estimate from the Congressional Budget Office (CBO) for the Biologics Price Competition and Innovation Act of 2007, which would establish an abbreviated regulatory pathway for follow-on biologics (see BioCentury Extra, Wednesday, June 25).

Non-antiarrhythmic drugs (PDF file) (June 30, 2008)
International Conference on Harmonization (ICH) Q&A on the clinical evaluation of non-antiarrhythmic drugs for QT/QTc interval prolongation and proarrhythmic potential.

Pharmacogenomics (PDF file) (June 30, 2008)
Final International Conference on Harmonization (ICH) concept paper supporting a proposal for a new harmonized ICH guideline on important aspects for the qualification of pharmacogenomic biomarkers.

Product documentation (June 30, 2008)
Baraclude: NICE's final appraisal recommending use of Baraclude entecavir to treat chronic HBV patients who are (HbeAG)-positive and HbeAG-negative, from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Tuesday, June 24). (PDF file)
Cymbalta: CHMP summary of opinion recommending a label expansion for Cymbalta duloxetine to treat generalized anxiety disorder (GAD), from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH. (PDF file)
Intelence: CHMP summary of opinion recommending conditional approval of Intelence etravirine (TMC125) to treat HIV-1 in antiretroviral treatment-experienced adults when used in combination with other antiretroviral agents, from Johnson & Johnson (NYSE:JNJ). (PDF file)
Pristiq: CHMP withdrawal assessment report on the agency's decision that the MAA for Pristiq desvenlafaxine is not approvable for treatment of vasomotor symptoms associated with menopause, from Wyeth (NYSE:WYE). (PDF file)
Rhucin: CHMP refusal assessment for Rhucin recombinant human complement 1 esterase inhibitor (rhC1INH) to treat acute attacks of hereditary angioedema (HAE), from Pharming Group N.V. (Euronext:PHARM).
Samska: Briefing documents for the June 25 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 8-3 to recommend approval of Samska tolvaptan for chronic oral treatment of hypervolemic or euvolemic hyponatremia, from Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768) (see Cover Story).
Sebivo: NICE's final appraisal recommending against the use of Sebivo telbivudine to treat HBV, from Novartis AG (NYSE:NVS; SWX:NOVN) and Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) (see BioCentury Extra, Tuesday, June 24). (PDF file)
Tracleer: CHMP summary of opinion recommending a label expansion for Tracleer bosentan to treat pulmonary arterial hypertension (PAH) WHO functional class II, from Actelion Ltd. (SWX:ATLN).
Vimpat: CHMP summary of opinion recommending approval for Vimpat lacosamide to treat partial-onset seizures in patients with epilepsy, from UCB Group (Euronext:UCB).

Biosimilars (June 23, 2008)
April 3 letter (PDF file) from House subcommittee on health to 35 groups seeking comments on a biosimilar approval pathway.

Cystic fibrosis (PDF file) (June 23, 2008)
EMEA draft guidance on development of medicinal products to treat CF.

Diabetes (PDF file) (June 23, 2008)
EMEA concept paper on the need to revise the CHMP note for guidance on the clinical investigation of medicinal products to treat diabetes mellitus.

Drug-eluting stents (PDF file) (June 23, 2008)
EMEA guidance on the preclinical and clinical testing of drug-eluting stents.

Gene therapy (PDF files) (June 23, 2008)
� EMEA guidance on the environmental risk of gene therapy and overview of comments received.
� EMEA draft guidance for clinical monitoring and follow-up after treatment with gene therapy medicinal products.
� EMEA guidance on preclinical studies necessary for gene therapies and overview of comments received.

Heparin (June 23, 2008)
Updated FDA information on adverse event reports for heparin.

Lipid disorders (PDF file) (June 23, 2008)
EMEA concept paper on the need for revision of the note for guidance on the clinical investigation of medicinal products in the treatment of lipid disorders.

Product documentation (June 23, 2008)
Enbrel: Briefing documents for the June 18 meeting of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee to review an sBLA for Enbrel etanercept treat plaque psoriasis in pediatric patients, from Amgen Inc. (NASDAQ:AMGN) and Wyeth (NYSE:WYE) (see "The Subtext Matters").
Exubera: EMEA Q&A on lung cancer cases in patients using Exubera inhaled insulin to treat Type I and Type II diabetes, from Pfizer Inc. (NYSE:PFE) and Nektar Therapeutics (NASDAQ:NKTR). (PDF file)
Gardasil: FDA updated the package insert to add arthralgia, myalgia, asthenia, fatigue, and malaise to the list of adverse events for Gardasil human papillomavirus (HPV) types 6, 11, 16 and 18 recombinant vaccine to prevent HPV in females age 9 to 26, from Merck & Co. Inc. (NYSE:MRK).
Kiacta: EMEA withdrawal assessment report for Kiacta eprodisate disodium to treat amyloid A (AA) amyloidosis, from Neurochem Inc. (TSX:NRM; NASDAQ:NRMX) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, March 13). (PDF file)
Neupro: Revised EMEA Q&A on the implementation of cold storage procedures for Neupro rotigotine transdermal patch to treat Parkinson's disease (PD), from UCB Group (Euronext:UCB). (PDF file)

Antiepileptic drugs (PDF file) (June 16, 2008)
FDA meta-analysis concluding antiepileptic drugs are associated with increased risk of suicidality relative to placebo (see BioCentury Extra, Thursday, June 12).

Heparin (PDF files) (June 16, 2008)
CHMP opinion and assessment report on medicinal products derived from or containing heparin.

Orphan drugs (PDF file) (June 16, 2008)
Summary of actions taken at the June 10-11 meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Pediatric drugs (PDF file) (June 16, 2008)
Summary of actions taken at the June 2-4 meeting of EMEA's Pediatric Committee (PDCO).

SBIR (June 16, 2008)
Information on the Small Business Innovation Research (SBIR) Bridge Award initiative launched by the National Cancer Institute (NCI) (see BioCentury Extra, Thursday, June 12).

Product Documentation (June 16, 2008)
Aquilda: Q&A on the withdrawal of an MAA for Aquilda satavaptan to treat euvolamic and hypervolemic dilutional hyponatremia, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
DuoPlavin: Q&A on the withdrawal of an MAA for DuoPlavin clopidogrel/acetylsalicylic acid to prevent atherothrombotic events in acute coronary syndrome (ACS) patients, from Bristol-Myers Squibb Co. (NYSE:BMY) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Invega: CHMP revised EPAR updating the SPC, labeling and package leaflet to include data from a study on drug interaction with carbamazepine in patients receiving Invega paliperidone to treat schizophrenia, from Johnson & Johnson (NYSE:JNJ). (PDF file)
Stalevo: CHMP revised EPAR updating the SPC, labeling and package leaflet to include the addition of the 200/50/200 mg tablet strength of Stalevo levodopa/carbidopa/entacapone to treat Parkinson's disease (PD), from Orion Corp. (HSE:ORNAV; HSE:ORNBV) and Novartis AG (NYSE:NVS; SWX:NOVN). (PDF file)
Ustekinumab: Briefing documents for the June 17 meeting of the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee to discuss a BLA for ustekinumab to treat moderate-to-severe psoriasis, from Johnson & Johnson (NYSE:JNJ) and Medarex Inc. (NASDAQ:MEDX) (see BioCentury Extra, Friday, June 13).
Zometa: CHMP revised EPAR updating the SPC and package leaflet to include incidence of atrial fibrillation in a trial, and information on overdose for Zometa zoledronic acid to treat bone metastases and bone complications in cancer patients, from Novartis AG (NYSE:NVS; SWX:NOVN). (PDF file)
Zyprexa: CHMP revised EPAR updating the SPC, labeling and package leaflet to recommend against use of Zyprexa olanzapine to treat schizophrenia and bipolar disorder in patients less than 18 years of age, from Eli Lilly and Co. (NYSE:LLY). (PDF file)

Advertising (June 9, 2008)
Transcripts from FDA's Risk Communication Advisory Committee meeting on May 15-16 to discuss direct-to-consumer (DTC) advertising.

Cellular therapies (PDF file) (June 9, 2008)
EMEA guidance on human cell-based medicinal products.

CHMP (PDF file) (June 9, 2008)
Summary report of actions taken at EMEA's CHMP plenary meeting May 27-30.

Heparin (June 9, 2008)
Updated FDA and EMEA (PDF file) Q&As on heparin products following recent contamination issues.

Pediatrics (June 9, 2008)
Briefing information for the June 9-10 meeting of the FDA's Pediatric Ethics subcommittee to discuss the ethics of pediatric clinical trials.

Preemption (PDF file) (June 9, 2008)
U.S. Department of Justice (DOJ) amicus brief filed in the U.S. Supreme Court case of Wyeth (NYSE:WYE) v. Levine, arguing preemption of state laws that challenge approved FDA labeling (see BioCentury Extra, Thursday, June 5).

TNF blockers (June 9, 2008)
FDA early communication about the investigation of 30 reports of cancer in children and young adults receiving an anti-TNF agent for diseases including juvenile idiopathic arthritis (JIA) and Crohn's disease (see BioCentury Extra, Wednesday, June 4).

Product Documentation (June 9, 2008)
Extavia: CHMP EPAR for Extavia interferon beta-1b to treat early stage and relapsing forms multiple sclerosis, from Novartis AG (NYSE:NVS; SWX:NOVN).
Lenalidomide Celgene Europe (U.S. - Revlimid): CHMP Q&A on its refusal of an MAA for Lenalidomide Celgene Europe to treat transfusion-dependent anemia due to myelodysplastic syndromes (MDS) with 5q chromosomal deletion, from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Monday, June 2). (PDF file)
Neupro: CHMP Q&A on the implementation of cold-storage procedures for Neupro rotigotine transdermal patch to treat Parkinson's disease, from UCB Group (Euronext:UCB). (PDF file)
OrBec: CHMP Q&A on the withdrawal of an MAA for OrBec beclomethasone dipropionate to treat gastrointestinal graft-versus-host disease (GvHD), from Dor BioPharma Inc. (OTCBB:DORB) (see BioCentury Extra, Thursday, May 22). (PDF file)
PEG-Intron: CHMP revised EPAR to update the SPC and package leaflet to include long-term assessment of virologic response for PEG-Intron peginterferon alpha-2b to treat HCV, from Schering-Plough Corp. (NYSE:SGP) and Enzon Pharmaceuticals Inc. (NASDAQ:ENZN). (PDF file)
Prepandrix: CHMP EPAR on Prepandrix split inactivated H5N1 influenza vaccine for use before a pandemic is declared, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Ramelteon: CHMP Q&A on its refusal of an MAA for Ramelteon to treat primary insomnia, from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Monday June 2). (PDF file)
Rebetol: CHMP revised EPAR to update the SPC and package leaflet with warning about concomitant use of Rebetol ribavirin and zidovudine in patients co-infected with HIV, from Schering-Plough Corp. (NYSE:SGP) and Enzon Pharmaceuticals Inc. (NASDAQ:ENZN). (PDF file)
Tygacil: CHMP Q&A on the withdrawal of an MAA fro Tygacil tigecycline to treat community acquired pneumonia (CAP), from Wyeth (NYSE:WYE). (PDF file)
Velcade: CHMP revised EPAR to update SPC and package leaflet to include acute diffuse infiltrative pulmonary and pericardial disease as a contraindication for Velcade bortezomib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Johnson & Johnson (NYSE:JNJ). (PDF file)
� Voraxaze: EMEA withdrawal assessment report and Q&A for Voraxaze glucarpidase to treat methotrexate toxicity in the blood, from Protherics plc (LSE:PTI; NASDAQ:PTIL). (PDF files)

Anti-TNF agents (PDF file) (June 2, 2008)
NICE guidance recommending for use of anti-TNF agents Enbrel etanercept from Wyeth (NYSE:WYE) and Amgen Inc. (NASDAQ:AMGN) and Humira adalimumab from Abbott Laboratories (NYSE:ABT), and against use of Remicade infliximab Johnson & Johnson (NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP) to treat severe, active ankylosing spondylitis in patients who have sustained active spinal disease and have failed at least two NSAIDs (see BioCentury Extra, Wednesday, May 28).

Biomarkers (PDF file) (June 2, 2008)
Final EMEA report describing the joint pilot EMEA/FDA project to qualify nephrotoxic biomarkers (see BioCentury Extra, Wednesday, May 28).

Conditional approval (PDF file) (June 2, 2008)
Text of the proposed Access, Compassion, Care and Ethics for Seriously Ill Patients (ACCESS) Act that seeks to create a conditional approval system to ensure that terminally ill patients have access to drug candidates and medical devices as early as the completion of Phase I testing (see BioCentury Extra, Wednesday, May 21).

Diabetes (PDF file) (June 2, 2008)
Updated NICE clinical guideline for the management of Type II diabetes.

EPO analogs (PDF file) (June 2, 2008)
NICE guidance that would restrict the use of erythropoietin (EPO) analogs to manage cancer treatment-induced anemia (see BioCentury Extra, Wednesday, May 28).

Product documentation (June 2, 2008)
— Adenuric: CHMP EPAR for Adenuric febuxostat to treat chronic hyperuricemia in conditions where urate deposition has already occurred; and a NICE preliminary appraisal recommending against the use of Adenuric to manage chronic hyperuricemia in patients with gout, from Ipsen Group (Euronext:IPN) and Teijin Pharma Ltd. (see BioCentury Extra, Wednesday, May 28).
Cimzia: EMEA refusal assessment report for Cimzia certolizumab pegol to treat Crohn's disease, from UCB Group (Euronext:UCB). (PDF file)
Evoltra: EMEA withdrawal assessment report for Evoltra clofarabine to treat acute myeloid leukemia (AML) in elderly patients, from Genzyme Corp. (NASDAQ:GENZ). (PDF file)
IntronA: CHMP revised EPAR updating the SPC and package leaflet to include results of two studies of IntronA interferon alfa-2b to treat chronic HCV in patients co-infected with HIV, from Schering-Plough Corp. (NYSE:SGP). (PDF file)
Mimpara: CHMP revised EPAR updating the SPC with results of a study showing no further reductions in free and total testosterone concentrations over a period of three years in patients receiving Mimpara cinacalcet to treat secondary hyperparathyroidism in patients with end-stage renal disease (ESRD) and to reduce hypercalcemia in patients with parathyroid carcinoma, from Amgen Inc. (NASDAQ:AMGN) and NPS Pharmaceuticals Inc. (NASDAQ:NPSP). (PDF file)
Norvir: CHMP revised EPAR updating the SPC and package leaflet to include data from studies on drug interactions with bupropion and rosuvastatin in patients taking Norvir ritonavir to treat HIV-1 infection, from Abbott Laboratories (NYSE:ABT). (PDF file)
Promacta: Briefing documents for the May 30 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC), which voted unanimously in favor of the risk/benefit profile of Promacta eltrombopag for short-term treatment of previously treated patients with chronic idiopathic thrombocytopenia purpura (ITP), from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Ligand Pharmaceuticals Inc. (NASDAQ:LGND) (see "Short Trumps Long"). (PDF file)

Biomarkers (PDF files) (May 26, 2008)
� CHMP mandate, objectives and rules of procedure for the pharmacogenomics working party.
� International Conference on Harmonization (ICH) concept paper supporting a proposal for a new harmonized guideline on the qualification of pharmacogenomics biomarkers.

Manufacturing (PDF files) (May 26, 2008)
� EMEA model for risk based planning for inspections of pharmaceutical manufacturers.
� FDA annual report summarizing the number and nature of deviation reports related to manufactured biological products during FY07.

Orphan drugs (PDF file) (May 26, 2008)
Summary of actions taken at the May 13-14 meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Postmarketing (May 26, 2008)
� EMEA updated Q&A on post-authorization procedures.

Undiagnosed diseases (May 26, 2008)
Website for NIH's new Undiagnosed Diseases Program to identify new diseases and create new knowledge of rare diseases (see BioCentury Extra, Monday, May 19).

Product Documentation (May 26, 2008)
Alimta: CHMP revised EPAR to include the new indication for Alimta pemetrexed for use in combination with cisplatin for first line treatment of non-squamous non-small cell lung cancer (NSCLC), from Eli Lilly and Co. (NYSE:LLY). (PDF file)
Hepsera: CHMP revised EPAR to update the SPC with long-term safety and resistance data for Hepsera adefovir to treat HBV infection, from Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)
Lyrica: CHMP revised EPAR to update the SPC and package leaflet to include risk of visual disturbances and angioedema for Lyrica pregabalin to treat epilepsy and other neurological disorders, from Pfizer Inc. (NYSE:PFE). (PDF file)
Nexavar: CHMP revised EPAR to update the SPC and package leaflet to include information about the risk of gastrointestinal perforation and add cholecystitus and cholangitis as adverse reactions for Nexavar sorafenib to treat renal cell and hepatocellular carcinomas, from Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) and Bayer AG (Xetra:BAY).
Privigen: CHMP EPAR for Privigen 10% formulation of IV immunoglobulin (IVIg) for use as a replacement therapy in immunodeficiency and for immunomodulation in immune-mediated diseases, from CSL Ltd. (ASX:CSL).
Truvada: CHMP revised EPAR to update the SPC and package leaflet to include 144-week follow-up data for antiretroviral-naïve patients receiving Truvada emtricitabine/tenofovir in combination with efavirenz to treat HIV-1 infection, from Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)
Viread: CHMP revised EPAR to include the new indication for Viread tenofovir for use in treating chronic HBV infection, from Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)

EMEA (PDF file) (May 19, 2008)
Annual report of the European Medicines Agency for 2007, including a summary of activities and performance metrics.

Influenza (May 19, 2008)
NICE preliminary guidance on the use of antivirals Tamiflu oseltamivir from Roche (SWX:ROG) and Relenza zanamivir from GlaxoSmithKline (LSE:GSK; NYSE:GSK) for post-exposure prophylaxis of influenza (see BioCentury Extra, Friday, May 16).

Pediatric drugs (PDF file) (May 19, 2008)
Summary of actions taken at the May 6-8 meeting of EMEA's Paediatric Committee (PDCO).

Product documentation (PDF files) (May 19, 2008)
Adrovance/Fosavance: CHMP revised EPAR updating the SPC to include periodontal disease as a risk factor for osteonecrosis of the jaw associated with bisphosphonates, including Adrovance/Fosavance alendronate to treat postmenopausal osteoporosis in patients at risk of vitamin D deficiency, from Merck & Co. Inc. (NYSE:MRK).
Axura: CHMP revised EPAR updating the SPC and package leaflet replacing the recommended twice-daily 10 mg dosing schedule with a once-daily 20 mg dose of Axura memantine to treat moderate to severe Alzheimer's disease, from Merz GmbH & Co. KGaA and Neurobiological Technologies Inc. (NASDAQ:NTII).
Ebixa: CHMP revised EPAR updating the SPC and package leaflet for a new treatment pack of 5, 10, 15 and 20 mg tablets of Ebixa memantine to treat moderate to severe Alzheimer's disease, from Merz GmbH & Co. KGaA and H. Lundbeck A/S (CSE:LUN).
Mircera: CHMP revised EPAR updating the SPC to note that no adjustments in starting dose nor of the dose modification rules are required in patients with severe hepatic impairment based on results of a pharmacokinetic study in patients receiving Mircera methoxy polyethylene glycol-epoetin beta to treat anemia, from Roche (SWX:ROG).
Neulasta: CHMP revised EPAR updating the SPC to include information about the potential for elevated liver function tests in patients taking Neulasta pegfilgrastim to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, from Amgen Inc. (NASDAQ:AMGN).
Reyataz: CHMP revised EPAR updating the SPC and package leaflet to include a recommendation of clinical monitoring for sedation and cognitive effects in patients receiving buprenorphine with ritonavir and Reyataz atazanavir to treat HIV-1, from Bristol-Myers Squibb Co. (NYSE:BMY).

Biosimilars (PDF file) (May 12, 2008)
Draft EMEA guideline for non-clinical and clinical requirements of biosimilars containing low molecular weight heparins (LMWHs).

CHMP (PDF file) (May 12, 2008)
Summary of actions taken at the April 21-24 meeting of EMEA's Committee for Medicinal Products for Human Use (CHMP).

Drug promotion (PDF file) (May 12, 2008)
Summary of revisions to the Code of Practice from the Association of the British Pharmaceutical Industry (ABPI), including requirements for pharmaceutical companies' relationships with patient groups and health professionals that will come into effect on July 1.

Fast Track (PDF file) (May 12, 2008)
FDA notice soliciting comments on collection of information related to the Fast Track designation program.

HCV (PDF file) (May 12, 2008)
Draft EMEA guidance on the clinical development of compounds to treat hepatitis C virus infection.

Osteoarthritis (PDF file) (May 12, 2008)
EMEA concept paper on the clinical development of medicinal products to treat osteoarthritis.

Pediatric drugs (PDF file) (May 12, 2008)
Draft of EMEA's revised priority list for studies to develop off-patent drugs for pediatric use.

Pharmacogenomics (PDF files) (May 12, 2008)
EMEA reflection paper on pharmacogenomics in oncology.
— Minutes from the March 18-19 meetings of the FDA's Pharmaceutical Science and Clinical Pharmacology advisory committees to discuss the agency's concept papers on clinical pharmacogenomics and renal impairment, respectively.

Toxicity Studies (PDF file) (May 12, 2008)
CHMP guidance for dose selection in carcinogenicity studies of pharmaceuticals.

Product Documentation (PDF files) (May 12, 2008)
Aquavan: Briefing documents for the May 7 meeting of the FDA's Anesthetic and Life Support Drugs Committee to review Aquavan fospropofol use as a sedative-hypnotic agent in adults undergoing diagnostic and therapeutic procedures, from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see "It's All About the Middleman").
Evoltra: Q&A on the withdrawal of an MAA for Evoltra clofarabine to treat acute myeloid leukemia (AML) in elderly patients, from Genzyme Corp. (NASDAQ:GENZ).
Hycamtin: CHMP revised EPAR to update SPC with a new oral formulation of Hycamtin topotecan to treat relapsed small cell lung cancer (SCLC), from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Neulasta: CHMP revised EPAR to update SPC and package leaflet with regard to the frequency of Sweet's syndrome associated with use of Neulasta/Neupopeg pegfilgrastim to treat neutropenia, from Amgen Inc. (NASDAQ:AMGN).
NovoSeven: CHMP revised EPAR to update SPC with a heat-tolerant formulation of NovoSeven eptacog alfa to treat hemophilia, from NovoNordisk A/S (CSE:NVO; NYSE:NVO).
Mycamine: CHMP EPAR for Mycamine micafungin to treat candidiasis, from Astellas Pharma Inc. (Tokyo:4503).
Rapamune: CHMP revised EPAR to update SPC and package leaflet to include data from a pharmacokinetic study in patients with severe hepatic impairment receiving Rapamune sirolimus to prevent organ rejection in renal transplant, from Wyeth (NYSE:WYE).
Visudyne: CHMP revised EPAR to update the SPC to warn of the risk of retinal pigment epithelial tear associated with use of Visudyne verteporfin to treat wet age-related macular degeneration (AMD), from Novartis AG (NYSE:NVS; SWX:NOVN) and QLT Inc. (TSX:QLT; NASDAQ:QLTI).
Xeloda: CHMP revised EPAR to update SPC to include five-year follow-up data for Xeloda capecitabine as an adjuvant therapy to treat colon cancer, from Roche (SWX:ROG).

Angiotensin receptor agonists (PDF file) (May 5, 2008)
EMEA Q&A characterizing the agency's stance against the use of angiotensin II receptor agonists to treat hypertension in women who are pregnant.

Drug delivery (May 5, 2008)
Description of proposed £5-£10 million ($10-$20 million) R&D initiative in intra-ocular delivery by ITI Life Sciences in Scotland (see Ebb & Flow).

Genetic testing (PDF file) (May 5, 2008)
NIH report on oversight of genetic testing in the U.S.

Innovative Medicines Initiative (May 5, 2008)
First call for proposals from Europe's Innovative Medicines Initiative (IMI) under a five-year, EUR2 billion ($3.1 billion) program to relieve bottlenecks in drug discovery and development (see BioCentury Extra, Wednesday, April 30).

Manufacturing (PDF file) (May 5, 2008)
FDA notice soliciting comments on the information collection provisions of the agency's current good manufacturing practice (CGMPs) regulations for finished pharmaceuticals.

SBIR/STTR (PDF file) (May 5, 2008)
SBIR/STTR Reauthorization Act that would make it easier for companies funded by VC firms to participate in the Small Business Innovation Research and Small Business Technology Transfer programs (H.R. 5819) (see BioCentury Extra, Monday, April 21).

TNF alpha inhibitors (May 5, 2008)
NICE preliminary guidance recommending against the use of a second TNF alpha inhibitor to treat rheumatoid arthritis (RA) after failure with a first TNF alpha inhibitor (see BioCentury Extra, Tuesday, April 29).

Product Documentation: (May 5, 2008)
Cinryze: Briefing documents for the May 2 meeting of FDA's Blood Products Advisory Committee, which voted unanimously that Cinryze complement 1 (C1) esterase inhibitor showed safety and efficacy for preventing attacks of hereditary angioedema (HAE), from Lev Pharmaceuticals Inc. (OTCBB:LEVP) (see Cover Story).
Enbrel: Dear Healthcare Professional letter describing label changes to reflect boxed warnings about the risk of infections including tuberculosis in patients taking Enbrel etanercept to treat arthritis or psoriasis, from Amgen Inc. (NASDAQ:AMGN) and Wyeth (NYSE:WYE). (PDF file)
Erbitux: NICE's final appraisal recommending use of Erbitux cetuximab in combination with radiotherapy to treat locally advanced squamous cell carcinoma of the head and neck (SCCHN) only in patients whose Karnofsky performance-status score is 90% or greater and for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated; from ImClone Systems Inc. (NASDAQ:IMCL) and Merck KGaA (Xetra:MRK) (see BioCentury Extra, Wednesday, April 30).
Fentora: Briefing documents for the May 6 joint meeting of FDA's Anesthetic and Life Support Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss an sNDA for Fentora fentanyl buccal tablets to manage breakthrough pain in opioid-tolerant non-cancer patients with chronic pain, from Cephalon Inc. (NASDAQ:CEPH) (see BioCentury Extra, Friday, May 2).
Humira: NICE final appraisal recommending the use of Humira adalimumab to treat plaque psoriasis in patients where the disease is severe and non-responsive to standard systemic therapies, from Abbott Laboratories (NYSE:ABT) (see BioCentury Extra, Tuesday, April 29). (PDF file)
Inovelon: CHMP revised EPAR updating the SPC and package leaflet to include changes in maximum dosing of Inovelon rufinamide for pediatric patients less than 30 kg also receiving valproate to treat seizures, from Synosia Therapeutics Inc. (PDF file)
OxyContin: Briefing documents for a May 5 joint meeting of FDA's Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss an NDA for extended-release OxyContin oxycodone for the management of moderate to severe pain, from Purdue Pharma L.P.
Vfend: CHMP revised EPAR updating the SPC and package leaflet to include warning on co-administration of short acting opiates similar in structure to alfentanil and metabolized by CYP3A4 with Vfend voriconazole to treat fungal infections, from Pfizer Inc. (NYSE:PFE). (PDF file)

CHMP (PDF file) (April 28, 2008)
Summary of actions taken at the April 21-24 meeting of EMEA's CHMP.

Diabetes (PDF file) (April 28, 2008)
NICE guidance recommending procedures for determining the use of allogenic pancreatic islet cell transplantation to treat Type I diabetes.

EMEA (PDF file) (April 28, 2008)
EMEA's Management Board report on the 2007 performance of the agency's scientific review of medicinal products.

ESAs (April 28, 2008)
Minutes from the March 13 meeting of FDA's Oncologic Drugs Advisory Committee to discuss use of erythropoeisis-stimulating agents in patients with cancer (see BioCentury, March 17).

Genetic non-discrimination (PDF file) (April 28, 2008)
Text of the Genetic Information Non-Discrimination Act (S. 358) (see BioCentury Extra, Thursday, April 24).

Orphan Drugs (PDF files) (April 28, 2008)
EMEA guidelines for the appeal of negative Orphan Drug designation decisions.

Photodynamic therapy (PDF file) (April 28, 2008)
"Special" NICE guidance recommending limited use of interstitial PDT to treat malignant parotid tumors.

Safety (PDF files) (April 28, 2008)
� Final FDA rule requiring that non-IND foreign clinical trials to support an IND or marketing application be conducted in accordance with good clinical practice (GCP).
Q&A from EudraVigilance Expert Working Group and Steering Committee, in consultation with CHMP Pharmacovigilance Working Party, to address implementation questions about the "Rules Governing Medicinal Products in the European Union: Pharmacovigilance for Medicinal Products for Human Use."
� EMEA reflection paper on risk-benefit assessment methods for evaluating MAAs.

Product Documentation (April 28, 2008)
Effentora: CHMP EPAR for Effentora fentanyl citrate (Fentora - U.S.) to treat breakthrough cancer pain in patients receiving maintenance opioid therapy, from Cephalon Inc. (NASDAQ:CEPH) (see BioCentury Extra, Monday, April 14). (PDF file)
Forsteo: CHMP revised EPAR to extend the indication to include osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk for fracture and to update SPC and package leaflet to include alkaline phosphatase increase as an adverse event for Forsteo teriparatide to treat osteoporosis, from Eli Lilly and Co. (NYSE:LLY). (PDF file)
Nplate: Minutes from the March 12 meeting of FDA's Oncologic Drugs Advisory Committee to discuss a BLA from Amgen Inc. (NASDAQ:AMGN) for Nplate romiplostim to treat thrombocytopenia in adults with idiopathic thrombocytopenic purpura (ITP) (see BioCentury, March 17).
Omnitrope: CHMP revised EPAR to update the SPC and package leaflet to delete contraindication in patients with Prader Willy Syndrome (PWS) and update the description without gender differences of the risk factors in patients with PWS for Omnitrope somatropin, from Novartis AG (NYSE:NVS, SWX:NOVN). (PDF file)
Orencia: NICE guidance recommending against use of Orencia abatacept from Bristol-Meyers Squibb Co. (NYSE:BMY) for patients with moderate to severe rheumatoid arthritis (RA) who have not responded to disease-modifying drugs (see BioCentury Extra, Wednesday, April 23). (PDF file)
Prevenar: CHMP revised EPAR to update the SPC and package leaflet to include new immunogenicity data for Prevenar pneumococcal saccharide conjugated vaccine to prevent pneumonia and otitis media, from Wyeth (NYSE:WYE). (PDF file)
Remicade: NICE guidance recommending against use of Remicade infliximab for patients with subacute, moderately to severe active ulcerative colitis (UC), from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Wednesday, April 23). (PDF file)
Tygacil: EMEA press release related to withdrawal of an application to extend marketing authorization for Tygacil tigecycline to treat community-acquired pneumonia, from Wyeth (NYSE:WYE). (PDF file)

Marketing applications (PDF file) (April 21, 2008)
Draft FDA guidance describing certifications that should be submitted in conjunction with marketing applications for drug, biological and device products as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Pediatric medicines (PDF file) (April 21, 2008)
Summary of actions taken at the April 9-11 meeting of EMEA's Pediatric Committee related to proposed pediatric investigation plans for drug products.

Product Documentation (PDF files) (April 21, 2008)
Hepsera: CHMP recommended updating SPC and package leaflet to revise the adverse events section to include the risk of renal failure, proximal renal tubulopathy, Fanconi syndrome, hypophosphatemia, myopathy and osteomalacia in patients taking Hepsera adefovir dipivoxil to treat chronic HBV, from Gilead Sciences Inc. (NASDAQ:GILD).
— Mylotarg: CHMP Q&A and the refusal assessment report against approval of an MAA for Mylotarg gemtuzumab ozogamicin to treat acute myeloid leukemia, from Wyeth (NYSE:WYE) and UCB Group (Euronext:UCB). The humanized antibody against CD33 is approved in the U.S. to treat patients with CD33-positive AML in first relapse who are 60 or older and who are not considered candidates for other cytotoxic chemotherapy.
— Sinerem: CHMP Q&A and withdrawal assessment report on the agency's decision that the MAA for Sinerem ferumoxtran-10 is not approvable for diagnostic use in the evaluation of primary tumor spread in patients with pelvic cancers, from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) (see BioCentury, Dec. 17, 2007).
Viread: CHMP revised EPAR updating the SPC and package leaflet warning of post-treatment hepatic flares as a risk for HIV/HBV co-infected patients discontinuing use of Viread tenofovir disoproxil fumarate to treat HIV, from Gilead Sciences Inc. (NASDAQ:GILD).
Zonegran: CHMP revised EPAR updating the SPC and package leaflet to strengthen warnings on allergic reactions to sulphonamides in patients taking Zonegran zonisamide to treat seizures, from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), Elan Corp. plc (NYSE:ELN) and Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506).

Antimicrobial resistance (PDF file) (April 14, 2008)
FDA request for comments ahead of an April 28 hearing about how to contain antimicrobial-resistant pathogens and to discuss potential provisions to the Orphan Drug Act to facilitate antimicrobial drug development (see BioCentury Extra, Friday, April 11).

Gene therapy (PDF file) (April 14, 2008)
FDA guidance with recommendations on chemistry, manufacturing and control (CMC) information to include in INDs for gene therapy (see BioCentury Extra, Wednesday, April 9).

Health Canada (April 14, 2008)
Proposed amendment to Canada's Food and Drugs Act introduced in the House of Commons to create total life cycle regulatory oversight of pharmaceuticals, as well as a briefing and concept paper (PDF file) from Health Canada regarding the framework for this proposed Progressive Licensing Model (see BioCentury, April 14).

Medicare (PDF file) (April 14, 2008)
Medicare Advantage capitation rate and Part D payment policies for calendar year 2009, from the Centers for Medicare & Medicaid Services (CMS).

Orphan Drugs (PDF file) (April 14, 2008)
Summary of actions taken at the April 8 meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Stem cells (PDF file) (April 14, 2008)
FDA guidance with recommendations on chemistry, manufacturing and control (CMC) information to include in INDs for human somatic stem cell therapies (see BioCentury Extra, Wednesday, April 9).

Product documentation (April 14, 2008)
� Baraclude: NICE initial appraisal recommending limited use of Baraclude entecavir on the NHS to treat HBV, from Bristol-Myers Squibb Co. (NYSE:BMY), plus a CHMP revised EPAR updating the SPC with a warning that Baraclude should not be used in HIV/HBV co-infected patients (see BioCentry, April 14).
Mirapexin: CHMP revised EPAR updating the SPC to reflect the occurrence of hypersexuality and allergic reactions for Mirapexin pramipexole (Mirapex – U.S.) to treat Parkinson’s disease (PD), from Boehringer Ingelheim GmbH and Pfizer Inc. (NYSE:PFE).
Pegasys: CHMP revised EPAR updating the SPC to include dehydration as an adverse event for Pegasys peginterferon alfa-2a to treat HBV and HCV infection, from Roche (SWX:ROG).
Pradaxa: CHMP EPAR for Pradaxa dabigatran etexilate to prevent venous thromboembolism after elective hip or knee replacement surgery, from Boehringer Ingelheim GmbH.
Sebivo: NICE initial appraisal recommending against the use of Sebivo telbivudine to treat HBV infection, from Novartis AG (NYSE:NVS; SWX:NOVN) and Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) (see BioCentury, April 14).
Visudyne: CHMP revised EPAR updating the SPC and package leaflet with safety information on post-marketing reports of myocardial infarction (MI) in patients receiving Visudyne verteporfin to treat subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), from Novartis AG (NYSE:NVS; SWX:NOVN) and QLT Inc. (TSX:QLT; NASDAQ:QLTI).
Xyrem: CHMP revised EPAR modifying the serious adverse events section to include the risk of insomnia, initial insomnia, restless legs syndrome, weight decrease, suicidal ideation and suicidal attempt for Xyrem sodium oxybate to treat cataplexy in patients with narcolepsy, from Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ).
Zenapax: CHMP revised EPAR to remove pregnancy as a contraindication while adding a warning that Zenapax daclizumab should not be used in pregnancy unless clearly necessary to prevent acute kidney transplant rejection, from Roche (SWX:ROG).

CAP (PDF file) (April 7, 2008)
"Recommended Design Features of Future Clinical Trials of Antibiotics for Community-Acquired Pneumonia," published by the Infectious Diseases Society of America (IDSA) (see "Uncapping the Logjam").

Product documentation (April 7,2008)
Kineret: CHMP revised EPAR updating the SPC to include the incidence of neutralizing antibodies in pediatric patients receiving Kineret anakinra to treat rheumatoid arthritis (RA), from Amgen Inc. (NASDAQ:AMGN).
Kivexa: CHMP revised EPAR updating the SPC of the possibility of late onset hepatitis with the use of Kivexa (Epzicom - U.S.) lamivudine/abacavir to treat HIV in combination with other antiretrovirals, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
MabThera: CHMP revised EPAR extending the indication for MabThera (Rituxan - U.S.) rituximab to include all chemotherapy combinations options for first-line follicular non-Hodgkin's lymphoma (NHL), from Roche (SWX:ROG), Biogen Idec Inc. (NASDAQ:BIIB) and Genentech Inc. (NYSE:DNA).
Relenza: Dear Healthcare Professional letter describing label changes to reflect postmarketing reports of delirium and abnormal behavior, particularly in pediatric patients, associated with Relenza zanamivir to treat influenza, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Biota Holdings Ltd. (ASX:BTA). (PDF file)
Revatio: CHMP revised EPAR updating the SPC to include postmarketing reports of sudden deafness/hearing loss associated with Revatio sildenafil to treat pulmonary arterial hypertension (PAH), from Pfizer Inc. (NYSE:PFE).
Tasmar: CHMP revised EPAR updating the SPC to warn about the possibility of late-onset hepatitis associated with the use of Tasmar in Parkinson's disease (PD) patients undergoing treatment with levodopa/cardiodopa, from Valeant Pharmaceuticals International (NYSE:VRX).
� Trizivir/Zigen: CHMP revised EPAR to include a recommendation that prescribers screen for carriage of the HLA-B*5701 allele before starting treatment with Trizivir/Zigen abacavir/lamivudine/zidovudine to treat HIV, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Vivanza: CHMP revised EPAR updating the SPC to include postmarketing reports of sudden deafness/hearing loss associated with Vivanza (Levitra - U.S.) vardenafil to treat pulmonary arterial hypertension (PAH), from Bayer AG (Xetra:BAY).

Anti-infective drugs (PDF file) (March 31, 2008)
Briefing documents for the April 1-2 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss design issues for clinical studies involving antibacterial agents to treat community acquired pneumonia and exposure-response analysis of CAP.

CHMP (PDF file) (March 31, 2008)
Summary of actions taken at the March meeting of the CHMP.

Embryonic stem cells (PDF file) (March 31, 2008)
Briefing documents for the April 10-11 meeting of FDA's Cellular, Tissue and Gene Therapies Advisory Committee to discuss considerations for preclinical safety testing of cellular therapies derived from human embryonic stem (hES) cells.

Genotoxicity (PDF file) (March 31, 2008)
Draft FDA guidance on genotoxicity testing and data interpretation meant to improve risk characterization for carcinogenic effects of pharmaceuticals that have their basis in the genetic material.

Pharmacogenomics (PDF files) (March 31, 2008)
Briefing materials for the March 18-19 meeting of FDA's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to discuss data collection requirements for clinical pharmacogenomics (PGx), plus the ICH note for guidance E15 on definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories (see "DNA Collection in the Clinic").

Risk management (March 31, 2008)
List (PDF file) of 16 approved products for which manufacturers will be required to submit a proposed risk evaluation (see BioCentury Extra, Wednesday, March 26).

Product documentation (March 31, 2008)
Mircera: CHMP revised EPAR updating the SPC and package leaflet for Mircera methoxy polyethylene glycol-epoetin beta regarding a consistent unexplained excess mortality in cancer patients with anemia treated with epoetin agents, from Roche (SWX:ROG).
— Vectibix: CHMP EPAR for Vectibix panitumumab for metastatic colorectal cancer, including the initially negative opinion of May 24, 2007 and the Sept. 20, 2007 reexamination leading to approval, plus a Q&A about the re-examination, from Amgen Inc. (NASDAQ:AMGN) (see Cover Story). (PDF files)
Zavesca: EMEA Q&A on the withdrawal of an MAA for Zavesca miglustat to treat neurological manifestations in patients with Niemann Pick type C disease, from Actelion Ltd. (SWX:ATLN).

CHMP (PDF file) (March 24, 2008)
Summary of actions taken at the March 17-19 meeting of EMEA's Committee for Medicinal Products for Human Use.

Counterfeit drugs (PDF file) (March 24, 2008)
Public consultation from the European Commission's Enterprise and Industry Directorate-General in preparation for a legal proposal to combat counterfeit drugs.

Drug prices (PDF file) (March 24, 2008)
Published results from survey conducted by the Association of the British Pharmaceutical Industry (ABPI) and the Confederation of British Industry (CBI) on the outlook for the U.K. pharma environment

Endocarditis (PDF file) (March 24, 2008)
NICE clinical practice guideline for antimicrobial agents to prevent infective endocarditis.

Product tracking (PDF file) (March 24, 2008)
FDA notice soliciting comments and information regarding technologies used for the identification, validation, tracking, tracing and authentication of prescription drugs.

Product documentation (March 24, 2008)
Ceplene: CHMP Q&A on its negative opinion for an MAA for Ceplene histamine in combination with interleukin-2 (IL-2) to maintain remission in patients with acute myelogenous leukemia (AML), from EpiCept Corp. (NASDAQ:EPCT; SSE:EPCT). (PDF file)
Champix: CHMP revised EPAR updating the SPC and package leaflet to include information on depression, suicidal ideation and suicidal attempt in patients receiving Champix varenicline to assist in smoking cessation, from Pfizer Inc. (NYSE:PFE). (PDF file)
Cimzia: CHMP Q&A on its negative opinion for an MAA for Cimzia certolizumab to treat Crohn's disease, from UCB Group (Euronext:UCB). (PDF file)
Evoltra: EMEA announcement on the withdrawal of an MAA for Evoltra clofarabine for the proposed indication to treat relapsed or refractory acute lymphoblastic leukemia (ALL) in elderly patients, from Genzyme Corp. (NASDAQ:GENZ). (PDF file)
Ketek: CHMP revised EPAR updating the SPC and package leaflet to restrict the use of the antibiotic Ketek telithromycin for chronic bronchitis, sinusitis and tonsillitis/pharyngitis, contraindicate the drug for patients with myasthenia gravis, and to strengthen warnings regarding visual disorders, loss of consciousness and to consider intake at bedtime, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Prevenar: CHMP revised EPAR updating the SPC and package leaflet to include immunogenicity and effectiveness data on the infant 3-dose primary vaccination schedule for Prevenar to prevent infection by Streptococcus pneumoniae, from Wyeth (NYSE:WYE). (PDF file)
Rhucin: CHMP Q&A on its negative opinion for an MAA for Rhucin recombinant human complement 1 esterase inhibitor (rhC1INH) to treat acute attacks of hereditary angioedema (HAE), from Pharming Group N.V. (Euronext:PHARM). (PDF file)
Sebivo: CHMP revised EPAR updating the SPC and package leaflet to include peripheral neuropathy with frequency uncommon as an adverse reaction and to inform of an increased risk of peripheral neuropathy in patients receiving Sebivo (Tyzeka-U.S.) telbivudine and pegylated interferon alfa-2a to treat chronic hepatitis B (HBV) infection, from Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) and Novartis AG (NYSE:NVS; SWX:NOVN). (PDF file)
Truvada: CHMP revised EPAR updating the SPC and package leaflet to include efficacy, safety and resistance data from a trial of Truvada emtricitabine/tenofovir in combination with efavirenz to treat HIV-1 infection in antiretroviral-naïve patients, from Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)
— Tysabri: EMEA statement and Q&A regarding its conclusion that warnings about liver injury should be added for Tysabri natalizumab to treat relapsing-remitting multiple sclerosis (MS), from Biogen Idec Inc. (NASDAQ:BIIB) and Elan Corp. plc (NYSE:ELN). (PDF files)
— Velcade: EMEA statement and Q&A regarding its recommendation to include a contraindication for patients with certain severe pulmonary or heart problems for Velcade bortezomib to treat progressive multiple myeloma, from Millennium Pharmaceuticals Inc. (NASDAQ:MLNM) and Johnson & Johnson (NYSE:JNJ). (PDF files)

EMEA (PDF file) (March 17, 2008)
Updated 2008 work plan from EMEA's Human Scientific Committees' Working Party.

ESAs (March 17, 2008)
Briefing documents for the March 13 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to discuss possible restrictions to the labels of erythropoiesis-stimulating agents (see Cover Story).

Hypertension drugs (PDF file) (March 17, 2008)
Draft FDA guidance to help companies develop labeling for cardiovascular claims for drugs to treat hypertension (see BioCentury Extra, Wednesday, March 12).

Marketing applications (March 17, 2008)
EMEA catalog (PDF file) of procedural advice for companies preparing to submit marketing applications under the centralized procedure; and for post-authorization procedures.

Multiple sclerosis (PDF file) (March 17, 2008)
Biologics Working Party's report to EMEA's CHMP related to the three marketed beta interferon drugs and their potential to induce neutralizing antibodies in MS patients.

Pharmacovigilance (PDF files) (March 17, 2008)
EMEA procedures for coordinating, conducting and reporting pharmacovigilance inspections requested by CHMP.

Toxicity (PDF file) (March 17, 2008)
Draft EMEA guideline on repeated dose toxicity studies to characterize the toxicological profile of a compound.

Trial design (PDF file) (March 17, 2008)
Report on the EMEA and European Federation of Pharmaceutical Industries and Associations (EFPIA) joint workshop on adaptive design for confirmatory clinical trials.

Product documentation (March 17, 2008)
Byetta: CHMP revised EPAR updating the SPC to include events of altered renal function and acute pancreatitis for Byetta exenatide to treat Type II diabetes, from Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) and Eli Lilly and Co. (NYSE:LLY). (PDF file)
CellCept: CHMP revised EPAR updating the SPC and package leaflet to include that cases of spontaneous abortions have been reported in patients exposed to CellCept mycophenolate mofetil during pregnancy to treat acute transplant rejection in patients receiving allogeneic transplants, from Roche (SWX:ROG). (PDF file)
Galvus: CHMP revised EPAR updating the SPC, labeling and package leaflet to strengthen the information concerning hepatic safety for Galvus vildagliptin to treat Type II diabetes, from Novartis AG (NYSE:NVS; SWX:NOVN). (PDf file)
Lyrica: CHMP revised EPAR updating the SPC and package leaflet to include urinary retention as a new safety issue and strengthen the warning for congestive heart failure (CHF) in patients receiving Lyrica pregabalin to treat neuropathic pain, epilepsy and generalized anxiety disorder, from Pfizer Inc. (NYSE:PFE). (PDF file)
Macugen: CHMP revised EPAR to include detailed description of the pharmacovigilance system for Macugen pegaptanib to treat wet age-related macular degeneration (AMD), from Pfizer Inc. (NYSE:PFE) and OSI Pharmaceuticals Inc. (NASDAQ:OSIP). (PDF file)
NeuroBloc: CHMP revised EPAR updating the SPC with data from an immunogenicity study of NeuroBloc botulinum toxin type B to treat cervical dystonia, from Solstice Neurosciences Inc. and Eisai Co. Ltd. (Tokyo:4523; Osaka:4523). (PDF file)
Nplate: Briefing documents for the March 12 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to discuss the overall benefits and risks of Nplate romiplostim to treat thrombocytopenia in adults with chronic idiopathic thrombocytopenic purpura (ITP), from Amgen Inc. (NASDAQ:AMGN).
Prezista: Dear Healthcare Professional letter to warn of the risk of hepatotoxicity in patients receiving Prezista darunavir to treat HIV infection, from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Wednesday, March 12). (PDF file)
Tandemact: CHMP revised EPAR updating the SPC and package leaflet to include a warning on the increased risk of hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency receiving Tandemact pioglitazone/glimepiride to treat Type II diabetes, from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). (PDF file)Diabetes mellitus (PDF file) (March 10, 2008)
Draft FDA guidance on the development of drugs and therapeutic biologics to treat and prevent diabetes mellitus (see Cover Story).

Hepatotoxicity (PDF files) (March 10, 2008)
Draft CHMP guideline for the detection of hepatotoxicity signals and mechanistic studies to assess the clinical relevance of non-clinical hepatotoxicity.

PAH (March 10, 2008)
NICE initial technology appraisal of five drugs to treat pulmonary arterial hypertension (see BioCentury Extra, Monday, March 3).

Reformulations (PDF file) (March 10, 2008)
Draft FDA guidance regarding the nonclinical evaluation of a new formulation of a previously approved drug substance and/or a product proposed for use by an alternate route of administration for which the product was not previously approved.

Ulcerative colitis (PDF file) (March 10, 2008)
EMEA guideline on the development of new medicinal products to treat UC.

Product documentation (March 10, 2008)
Abilify: CHMP revised EPAR adding diarrhea and increased alkaline phosphate as postmarketing adverse events reported for Abilify aripiprazole to treat schizophrenia and manic episodes associated with bipolar I disorder, from Bristol-Myers Squibb Co. (NYSE:BMY) and Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768).
Bridion: Briefing documents for the March 11 meeting of FDA’s Anesthetic and Life Support Drugs Advisory Committee to discuss an NDA for Bridion sugammadex to reverse neuromuscular blockade induced by muscle relaxants, from Schering-Plough Corp. (NYSE:SGP) (see BioCentury Extra, Friday, March 7).
Caelyx: CHMP revised EPAR extending the indication for Caelyx (Doxil-U.S.) doxorubicin to include treatment of recurrent progressive multiple myeloma, from Schering-Plough Corp. (NYSE:SGP).
Eucreas: CHMP revised EPAR updating the SPC to strengthen warning language concerning hepatic safety associated with Eucreas vildagliptin/metformin to treat Type II diabetes, from Novartis AG (NYSE:NVS; SWX:NOVN).
Telzir: CHMP revised EPAR recommending that phenytoin plasma concentrations be monitored and adjusted as appropriate when co-administered with Telzir fosamprenavir calcium (Lexiva-U.S.) to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Twinrix: CHMP revised EPAR to include hypoesthesia, lichen planus and muscle weakness to the list of undesirable effects of Twinrix pediatric combined hepatitis A and hepatitis B vaccine, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Viraferonpeg: CHMP revised EPAR updating the SPC to include reports of Vogt-Koyanagi-Harada syndrome in patients receiving Viraferonpeg (PegIntron) peginterferon alfa-2b to treat hepatitis C (HCV), from Schering-Plough Corp. (NYSE:SGP).
Zavesca: Notice of the withdrawal of an application to extend the European label to include the treatment of Niemann-Pick type C disease for Zavesca (Vevesca) miglustat, which is approved for Type I Gaucher's disease in patients not candidates for enzyme replacement therapy, from Actelion Ltd. (SWX:ATLN).

Diabetes (PDF file) (March 3, 2008)
Draft FDA guidance on the development of therapeutics to treat or prevent Type I and Type II diabetes (see BioCentury Extra, Friday, Feb. 29).

FDA preemption (PDF file) (March 3, 2008)
Oral arguments from Warner-Lambert v. Kent, the U.S. Supreme Court case involving FDA preemption provisions in a Michigan law (see "Supreme Preemption").

Irritable bowel syndrome (PDF file) (March 3, 2008)
NICE clinical practice guideline for the diagnosis and management of irritable bowel syndrome (IBS) in adults.

Osteoarthritis (PDF file) (March 3, 2008)
NICE clinical guideline for osteoarthritis.

Pediatric drugs (PDF file) (March 3, 2008)
Summary of actions taken at the Feb. 13-15 meeting of EMEA's Pediatric Committee (PDCO).

Prostate cancer (PDF file) (March 3, 2008)
NICE clinical guideline for the diagnosis and treatment of prostate cancer.

Product documentation (March 3, 2008)
Evista: CHMP revised EPAR updating the SPC and package leaflet with data from three clinical trials assessing the effects of Evista raloxifene on the incidence of invasive breast cancer and cardiovascular events to treat and prevent osteoporosis in postmenopausal women, from Eli Lilly and Co. (NYSE:LLY).
Heparin: FDA's redacted report that found "objectionable conditions" during an inspection of the Changzhou SPL Co. Ltd. facility that manufactures API for anticoagulant heparin from Baxter International Inc. (NYSE:BAX) (see BioCentury Extra, Thursday, Feb. 28).
MabThera: NICE's final guidance on the use of MabThera rituximab as a maintenance therapy for relapsed/refractory follicular non-Hodgkin's lymphoma (NHL) in patients who respond to induction therapy with chemotherapy with or without MabThera, from Biogen Idec Inc. (NASDAQ:BIIB), Genentech Inc. (NYSE:DNA) and Roche (SWX:ROG).
Orgalutran: CHMP revised EPAR updating the SPC and package leaflet to include warnings on tubal abnormalities and reports of ectopic pregnancies in patients receiving Orgalutran ganirelix to prevent premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART), from Schering-Plough Corp. (NYSE:SGP).
Optruma: CHMP revised EPAR updating the SPC and package leaflet with data from three clinical trials assessing incidence of invasive breast cancer and cardiovascular events in patients receiving Optruma raloxifene to treat and prevent osteoporosis in postmenopausal women, from Eli Lilly and Co. (NYSE:LLY).
PegIntron: CHMP revised EPAR updating the SPC and package leaflet with information on the risk of Vogt-Koyanagi-Harada (VKH) syndrome, an immune mediated disease, in patients receiving PegIntron pegylated interferon alfa-2b to treat chronic hepatitis C virus (HCV), from Schering-Plough Corp. (NYSE:SGP).
Raptiva: CHMP revised EPAR updating the SPC and package leaflet to include a warning of spontaneous reports of facial palsy in patients receiving Raptiva efalizumab to treat moderate to severe chronic plaque psoriasis, from Genentech Inc. (NYSE:DNA), Merck KGaA (FSE:MRK) and Xoma Ltd. (NASDAQ:XOMA).
Tysabri: "Dear Healthcare Professional" letter warning of reports of clinically significant liver injury after receiving Tysabri natalizumab to treat Crohn's disease and multiple sclerosis (MS) from Biogen Idec Inc. (NASDAQ:BIIB) and Elan Corp. plc (NYSE:ELN) (see BioCentury Extra, Wednesday, Feb. 27).

ADHD (PDF file) (February 25, 2008)
Draft EMEA concept paper on the development of guidelines for therapeutics to treat attention deficit hyperactivity disorder (ADHD).

CHMP (PDF file) (February 25, 2008)
Summary of actions taken at the Feb. 18-21 meeting of EMEA’s Committee for Medicinal Products for Human Use.

CMS (PDF files) (February 25, 2008)
Centers for Medicare & Medicaid Services report to Congress outlining the design and implementation of a bundled payment system for treatment of end-stage renal disease (ESRD) (see BioCentury Extra, Thursday, Feb. 21).
Government Accountability Office (GAO) report recommending improvements in processing by sponsors and monitoring by CMS of drug coverage requests.

NIH (PDF file) (February 25, 2008)
Draft recommendations for changes to the NIH peer review process for grant applications for biomedical and behavioral research (see BioCentury Extra, Thursday, Feb. 21).

Patents (PDF files) (February 25, 2008)
Biotechnology Industry Organization (BIO) report on the economic implications of patent reform legislation pending in the U.S. Senate.
Congressional Budget Office (CBO) report estimating the cost of enacting patent reform legislation pending in the U.S. Senate (S. 1145).

Preemption (PDF file) (February 25, 2008)
U.S. Supreme Court ruling in favor of Medtronic Inc. (NYSE:MDT) in Riegel v. Medtronic Inc., affirming that FDA pre-marketing approvals for devices preempt state laws (see BioCentury Extra, Wednesday, Feb. 20).

Pulmonary hypertension (PDF file) (February 25, 2008)
EMEA concept paper on the development of CHMP guideline for clinical investigations of medicinal products to treat pulmonary hypertension.

Product documentation (February 25, 2008)
Neupro: CHMP revised EPAR extending the indication of Neupro rotigotine to include the treatment of signs and symptoms of advanced idiopathic Parkinson’s disease in combination with levodopa, from UCB Group (Euronext:UCB).
Protelos: CHMP revised EPAR amending the SPC to include Stevens-Johnson syndrome, severe hypersensitivity syndromes and musculoskeletal pain as adverse reactions associated with use of Protelos (Osseor) strontium ranelate treat post-menopausal osteoporosis to reduce the risk of vertebral and hip fractures, from Servier.
Xyrem: CHMP revised EPAR amending the SPC to include insomnia and restless legs syndrome (RLS) as adverse reactions associated with use of Xyrem sodium oxybate to treat cataplexy and excessive daytime sleepiness in narcolepsy patients, from UCB Group (Euronext:UCB), which has rights from Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ).

Cell/Gene therapy (PDF file) (February 18, 2008)
Draft FDA guidance regarding recommendations for manufacturers of cellular and gene therapy products on the validation of growth-based rapid microbiological methods (RMMs) for sterility testing.

Diagnostics (PDF file) (February 18, 2008)
Draft FDA guidance regarding recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostics intended for the detection and/or differentiation of influenza viruses.

Off-label (PDF file) (February 18, 2008)
Draft FDA guidance for the distribution of medical journal articles and scientific or medical reference publications to healthcare professionals and healthcare entities that discuss unapproved new uses for approved drugs, biologics and medical devices (see BioCentury Extra, Friday, Feb. 15).

Pharmacology (PDF file) (February 18, 2008)
Notice of March 18 meeting of FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss new concept papers on clinical pharmacogenomics and renal impairment, and to discuss and solicit comments on quantitative clinical pharmacology.

Toxicity (PDF file) (February 18, 2008)
FDA guidance recommending when and how to identify and characterize small molecule drug metabolites whose nonclinical toxicity needs to be evaluated.

Product documentation (February 18, 2008)
Remicade: CHMP revised EPAR updating the SPC and package leaflet to include interstitial lung disease as an adverse event associated with use of Remicade infliximab to treat Crohn's disease, psoriasis, ankylosing spondylitis, ulcerative colitis (UC), rheumatoid arthritis (RA) and psoriatic arthritis, from Johnson & Johnson (NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP).
Rotarix: Briefing documents for the Feb. 20 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss a BLA for Rotarix oral attenuated rotavirus vaccine to prevent gastroenteritis due to rotavirus infection in children, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Avant Immunotherapeutics Inc. (NASDAQ:AVAN) (see BioCentury Extra, Friday, Feb. 15).
Tesavel: CHMP EPAR for Tesavel (Januvia) sitagliptin to treat Type II diabetes, from Merck & Co. Inc. (NYSE:MRK).
Velcade: CHMP revised EPAR recommending close monitoring of patients receiving Velcade bortezomib in combination with potent CYP3A4 inhibitors or CYP2C19 inhibitors in patients with multiple myeloma (MM), from Johnson & Johnson (NYSE:JNJ) and Millennium Pharmaceuticals Inc. (NASDAQ:MLNM).

Adverse events (PDF file) (February 11, 2008)
Memorandum of understanding between FDA and NIH regarding joint efforts to create a unified federal adverse event reporting system (see BioCentury Extra, Friday, Feb. 8).

Influenza vaccines (PDF file) (February 11, 2008)
CHMP recommendations to the risk management plan for influenza vaccines prepared from viruses with the potential to cause a pandemic.

Product documentation (February 11, 2008)
Abraxane: CHMP EPAR for Abraxane paclitaxel to treat metastatic breast cancer, from Abraxis BioScience Inc. (NASDAQ:ABII).
Humira: CHMP revised EPAR to extend the label to include treatment of adults with moderate to severe chronic plaque psoriasis, from Abbott Laboratories (NYSE:ABT).
Ivemend: CHMP EPAR for Ivemend/Emend fosaprepitant dimeglumine to prevent chemotherapy-induced nausea and vomiting (CINV), from Merck & Co. Inc. (NYSE:MRK).
Ketek: CHMP revised EPAR restricting the use of antibiotic Ketek telithromycin for chronic bronchitis, acute sinusitis and tonsillitis/pharyngitis caused by certain resistant strains and to recommend taking it at bedtime to minimize visual disturbances, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
MabCampath: CHMP revised EPAR extending the label for MabCampath alemtuzumab to include first-line to treat B cell chronic lymphocytic leukemia (B CLL), from Genzyme Corp. (NASDAQ:GENZ). (PDF file)
Rotarix: CHMP revised EPAR updating the SPC with class labeling on the risk of apnea following vaccination of very prematurely born infants with Rotarix oral attenuated rotavirus vaccine to prevent gastroenteritis, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Avant Immunotherapeutics Inc. (NASDAQ:AVAN).
RotaTeq: CHMP revised EPAR stating that a review of clinical data found no reason to preclude the use of RotaTeq rotavirus vaccine in infants born at a gestational age of at least 25 weeks, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Sutent: CHMP revised EPAR with information regarding the adverse effects rhabdomyolysis and myopathy and serious infections in patients receiving Sutent sunitinib to treat gastrointestinal stromal tumor (GIST) and renal cell carcinoma (RCC), from Pfizer Inc. (NYSE:PFE).
Tarceva: CHMP revised EPAR including pharmacokinetic data for patients with advanced solid tumors and adequate or moderately impaired hepatic function for Tarceva erlotinib to treat pancreatic and non-small cell lung cancer (NSCLC), from Roche (SWX:ROG), Genentech Inc. (NYSE:DNA) and OSI Pharmaceuticals Inc. (NASDAQ:OSIP).
Truvada: CHMP revised EPAR updating the SPC and package leaflet of Truvada emtricitabine/tenofovir to include anemia in the list of adverse reactions, from Gilead Sciences Inc. (NASDAQ:GILD).
Zerit: CHMP revised EPAR updating the SPC and package leaflet with class labeling on the incidence of osteonecrosis and the use of combination antiretroviral therapy associated with Zerit stavudine to treat HIV infection, from Bristol-Myers Squibb Co. (NYSE:BMY).
Zypexa: CHMP revised EPAR updating the SPC to include warning information on the risk of mean change in glucose levels and that lipid levels in patients receiving Zyprexa Adhera olanzapine to treat schizophrenia, from Eli Lilly and Co. (NYSE:LLY).

Clinical effectiveness (February 4, 2008)
Institute of Medicine (IOM) report summary recommending the creation of a national clinical effectiveness assessment program (see BioCentury Extra, Monday, Jan. 28).

CMS (February 4, 2008)
Biotechnology Industry Organization (BIO) comments (PDF file) on the final rule by the Centers for Medicare and Medicaid Services regarding revisions to the hospital outpatient prospective payment system (OPPS) and 2008 payment rates (see BioCentury Extra, Friday, Feb. 1).

Dementia (PDF file) (February 4, 2008)
EMEA notice of a Feb. 11 workshop of European experts to discuss and debate regulatory requirements for developing therapeutics for neurodegenerative diseases with a focus on dementia.

HIV (February 4, 2008)
� EMEA guideline on carcinogenicity evaluation of medicinal products to treat HIV infection.
� EMEA draft reflection paper on the in vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors (NRTIs).

In vitro diagnostics (PDF file)
FDA guidance recommending approaches for determining whether a laboratory test may be considered sufficiently "simple" to be granted a Clinical Laboratory Improvement Amendments (CLIA) waiver to be performed by laboratories.

Product documentation (February 4, 2008)
� Adrovance: CHMP revised EPAR updating the SPC to add periodontal disease as a risk factor for osteonecrosis of the jaw (ONJ) in association with bisphosphonates for Adrovance/Fosavance alendronate to treat postmenopausal osteoporosis in patients at risk of vitamin D insufficiency, from Merck & Co. Inc. (NYSE:MRK). (PDF files)
Alimta: NICE final technology appraisal guidance recommending conditions for use of pemetrexed to treat malignant pleural mesothelioma, from Eli Lilly and Co. (NYSE:LLY).
Baraclude: CHMP revised EPAR updating the SPC to include data confirming the signal of an increased risk of HIV resistance developing in HIV/HBV co-infected patients receiving Baraclude entecavir to treat chronic hepatitis B (HBV) infection, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Combivir: CHMP revised EPAR updating the SPC concerning interactions with clarithromycin and ribavirin in patients receiving Combivir lamivudine/zidovudine to treat HIV, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Cymbalta: CHMP revised EPAR updating the SPC regarding gastrointestinal bleeding, withdrawal symptoms and dosing for Cymbalta/Xeristar duloxetine to treat major depressive episodes and diabetic peripheral neuropathic pain, from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH. (PDF file)
NovoMix: CHMP revised EPAR updating the SPC to include information about pediatric use for NovoMix insulin aspart to treat diabetes mellitus, from Novo Nordisk A/S (CSE:NVO; NYSE:NVO). (PDF file)
NutropinAq: EMEA announcement on the withdrawal of an MAA for NutropinAq somatropin for the proposed indication to treat children with severe idiopathic short stature, from Genentech Inc. (NYSE:DNA) and Ipsen Group (Euronext:IPN). (PDF file)
Prezista: CHMP revised EPAR updating the SPC and package leaflet with results from a study on the pharmacokinetic interaction between lopinavir, ritonavir and Prezista darunavir to treat HIV infection, from Johnson & Johnson (NYSE:JNJ). (PDF file)
Remicade: NICE final technology appraisal guidance on conditions for use of Remicade infliximab to treat adults with plaque psoriasis, from Johnson & Johnson (NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP).
Reyataz: CHMP revised EPAR updating the SPC and package leaflet with data regarding the potential for drug-drug interactions between proton pump inhibitors and Reyataz atazanavir to treat HIV-1, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Somavert: CHMP revised EPAR updating the SPC and package leaflet with respect to injection site reaction adverse events for Somavert pegvisomant to treat acromegaly, from Pfizer Inc. (NYSE:PFE). (PDF file)
Trizivir: CHMP revised EPAR updating the SPC concerning interactions with clarithromycin and ribavirin in patients receiving Trizivir abacavir/lamivudine/zidovudine to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Velcade: CHMP revised EPAR updating the SPC with the results of two drug interaction studies with a CYP3A4 inhibitor and a CYP2C19 inhibitor for Velcade bortezomib to treat progressive multiple myeloma, from Millennium Pharmaceuticals Inc. (NASDAQ:MLNM) and Johnson & Johnson (NYSE:JNJ). (PDF file)
Zometa: EMEA Q&A on the withdrawal of an MAA for Zometa zoledronic acid for the proposed indication to prevent fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors, from Novartis AG (NYSE:NVS; SWX:NOVN). (PDF file)

Antivirals (PDF file) (January 28, 2008)
Updated EMEA review of influenza antiviral medicinal products for potential use during pandemic influenza outbreak.

Atrial fibrillation (January 28, 2008)
ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation (see BioCentury, Jan. 28).

CHMP opinions (PDF file) (January 28, 2008)
Summary of actions taken at the Jan. 21-24 meeting of EMEA’s CHMP.

Epigenomics (January 28, 2008)
Information on the NIH’s $190 million program to fund epigenetic research as part of the agency’s Roadmap initiative.

Vaccines (PDF file) (January 28, 2008)
Work plan for the EMEA’s Vaccines Working Party (VWP), including 2008 schedule and list of new guidelines.

Product documentation (January 28, 2008)
Avamys: CHMP EPAR for Avamys fluticasone furoate nasal spray to treat symptoms of allergic rhinitis from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Avastin: CHMP revised EPAR adding information relating to fistulae cases in patients receiving Avastin bevacizumab to treat colorectal, breast and non-small cell lung cancer, from Roche (SWX:ROG) and Genentech Inc. (NYSE:DNA).
Caelyx: CHMP revised EPAR extending the label for Caelyx doxorubicin to include use Velcade bortezomib to treat progressive multiple myeloma (MM) in patients who have received at least one prior therapy, from Schering-Plough Corp. (NYSE:SGP).
Gardasil: EMEA statement on reports of two unexpected deaths in patients given Gardasil HPV vaccine from Merck & Co. Inc. (NYSE:MRK) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Injectafer: Notice of Feb. 1 meeting of FDA’s Drug Safety and Risk Management Advisory Committee to discuss an NDA from Daiichi for IV Injectafer ferric carboxymaltose (VIT-45) to treat iron deficiency anemia in heavy uterine bleeding, postpartum, inflammatory bowel disease or hemodialysis patients, from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568). (PDF file)
Prevenar: CHMP revised EPAR updating the SPC to update information on the risk of apnea in very prematurely born infants receiving Prevenar/Prevnar vaccine against pneumonia and invasive pneumococcal disease, from Wyeth (NYSE:WYE).
Targretin: CHMP revised EPAR updating the SPC advising caution in case of combination of CYP3A4 substrate with Targretin bexarotene to treat advanced cutaneous T cell lymphoma, from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).
Tracleer: CHMP revised EPAR updating the SPC and package leaflet to include information about adverse events related to anemia, decreased hemoglobulin and thrombocytopenia for Tracleer bosentan to treat peripheral arterial hypertension (PAH), from Actelion Ltd. (SWX:ATLN).
Xeristar: CHMP revised EPAR to update the SPC to include information about gastrointestinal bleedings and withdrawal symptoms for Xeristar duloxetine to treat major depressive disorder, diabetic peripheral neuropathic pain and generalized anxiety disorder, from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY).

Advisory committees (PDF file) (January 21, 2008)
FDA's tentative schedule of meetings of its public advisory committees for 2008.

Antimicrobial drugs (PDF files) (January 21, 2008)
Notice of April 1-2 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss product development and clinical trial design for community-acquired pneumonia (CAP) (see "Hint on Non-Inferiority").
� Draft FDA guidance for developing antimicrobial drugs to treat acute bacterial otitis media (see BioCentury Extra, Friday, Jan. 18).

Drug access (PDF files) (January 21, 2008)
December 2006 proposed FDA rules on "Expanded Access to Investigational Drugs for Treatment Use" and "Charging for Investigational Drugs" (see "Abigail's Next Steps").

Drug interactions (PDF file) (January 21, 2008)
CHMP's Q&A on the use of "cocktail studies" that employ probe drugs for specific enzymes to investigate the potential for in vivo drug interaction.

Label changes (PDF file) (January 21, 2008)
FDA notice soliciting comments on proposal to codify the agency's position that a supplemental application be submitted to make label changes for drugs, biologics or medical devices (see BioCentury Extra, Wednesday, Jan. 16).

Manufacturing (PDF file) (January 21, 2008)
CHMP Q&A on the 2006 guideline regarding the limits of genotoxic impurity levels in active pharmaceutical ingredients.

Orphan drugs (PDF file) (January 21, 2008)
FDA notice soliciting comments on the procedures by which sponsors of orphan drugs may request eligibility for the incentives, and the joint adoption by FDA and EMEA of the Common EMEA/FDA Application Form for Orphan Drug designation.

Pediatric drugs (January 21, 2008)
EMEA notice of an April 14-15 workshop on modeling and simulation of pediatric response to medicines.

Product documentation (January 21, 2008)
Cubicin: CHMP revised EPAR updating the SPC to include post-marketing information on renal insufficiency, peripheral neuropathy and interference with particular reagents used in protrombin time/international normalized ratio (PT/INR) assays in patients receiving Cubicin daptomycin to treat bacterial infections, from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) and Novartis AG (NYSE:NVS; SWX:NOVN).
Elaprase: CHMP revised EPAR updating the SPC and package leaflet to include additional safety information regarding infusion-related reactions in patients receiving Elaprase idursulfase to treat Hunter syndrome (Mucopolysaccharidosis II, MPS II), from Shire plc (LSE:SHP; NASDAQ:SHPGY).
Entereg: Briefing documents for the Jan. 23 meeting of FDA's Gastrointestinal Drugs Advisory Committee to discuss Entereg alvimopan to treat postoperative ileus (POI) from Adolor Corp. (NASDAQ:ADLR) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Friday, Jan. 18).
Rapamune: CHMP revised EPAR updating the SPC to include tuberculosis, pleural effusion, and incisional hernia as adverse events, and include information on male fertility for Rapamune sirolimus to prevent organ rejection in patients receiving renal transplants, from Wyeth (NYSE:WYE).
Tygacil: CHMP revised EPAR updating the SPC to include anaphylactic reaction, and information on early detection of the onset or worsening acute pancreatitis and the need for monitoring of patients receiving Tygacil tigecycline to treat complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI), from Wyeth (NYSE:WYE).

Centralized procedure (PDF file) (January 14, 2008)
EMEA document on scientific aspects and working definitions for the mandatory scope of the centralized recognition procedure, to clarify which therapeutic indication fall in the mandatory area.

EMEA Road Map (PDF file) (January 14, 2008)
Outline of 2008-2009 implementation phase of the EMEA Road Map project.

NICE (PDF file) (January 14, 2008)
U.K. House of Commons' Health Select Committee report recommending that the National Institute for Health and Clinical Excellence (NICE) initially assess all new drugs via a "shorter, less in-depth initial evaluation" (see BioCentury Extra, Thursday, Jan. 10).

Pediatric drugs (PDF file) (January 14, 2008)
Summary of actions taken at the Dec. 18-20 meeting of EMEA's Paediatric Committee (PDCO).

Pharmacovigilance (PDF files)
EMEA's executive summary report, summary of the outcome of working groups, and participants of the June 28, 2007, meeting on European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) to identify, characterize and assess risks relating to medicinal products marketed in Europe.

Protein therapeutics (PDF file) (January 14, 2008)
EMEA guideline on immunogenicity assessment of biotechnology derived therapeutic proteins.

Product documentation (PDF files) (January 14, 2008)
Agenerase: CHMP revised EPAR updating the SPC summarizing the emergent mutations observed during clinical trials of fosamprenavir in patients receiving Agenerase amprenavir with other antiretroviral agents to treat HIV-1 infection, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Ceftobiprole: Notice of a Feb. 28 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss an NDA for ceftobiprole to treat complicated skin and skin structure infections (cSSSIs), from Johnson & Johnson (NYSE:JNJ).
Telavancin: Notice of a Feb. 27 meeting of FDA's Anti-Infective Drugs Advisory Committee to review an NDA for telavancin to treat complicated skin and skin structure infections (cSSSIs) from Theravance Inc. (NASDAQ:THRX) and Astellas Pharma Inc. (Tokyo:4503).

CAP (PDF file) (January 7, 2008)
FDA notice of Jan. 17-18 workshop to discuss designing clinical trials for agents to treat community-acquired pneumonia.

FDA preemption (PDF file) (January 7, 2008)
The U.S. Solicitor General brief submitted to the U.S. Supreme Court on Dec. 21, 2007, reaffirming the U.S. government's contention that FDA labels preempt state laws (see BioCentury Extra, Monday, Dec. 31, 2007).

Non-inferiority studies (PDF file) (January 7, 2008)
FDA notice that the comment period has been re-opened until Feb. 8 to solicit input on the agency's draft guidance on the use of non-inferiority studies to support approval of antibacterial drug products (see BioCentury Extra, Friday, Jan. 4).

PDUFA (PDF file) (January 7, 2008)
Draft FDA plan to guide direction and implementation of IT projects initiated to meet the objectives set out in PDUFA IV.

Research programs (PDF file) (January 7, 2008)
Notice of a meeting of FDA's Cellular, Tissue and Gene Therapies Advisory Committee on Feb. 5 to hear updates of research programs in CDER's Division of Therapeutic Proteins and the Division of Monoclonal Antibodies.

Strategic stockpile (PDF file) (January 7, 2008)
FDA interim final rule on exceptions or alternatives to labeling requirements for investigational drugs, biologics and devices held by the United States Strategic National Stockpile (SNS).

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