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

Comparative effectiveness (PDF file) (December 24, 2007)
Congressional Budget Office's (CBO) report on the potential for comparative effectiveness research to improve health care outcomes (see BioCentury Extra, Friday, Dec. 21).

Stem cells (PDF file) (PDF file) (December 24, 2007)
Notice of an April 10 meeting of FDA's Cellular, Tissue and Gene Therapies Advisory Committee to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells.

Venous thromboembolism (PDF file) (PDF file) (December 24, 2007)
CHMP guideline for developing new medicinal products to prevent and treat intra- and post-operative venous thrombosis in the abdominal and orthopedic surgery setting.

Product documentation (PDF file) (December 24, 2007)
Atripla: CHMP EPAR for Atripla emtricitabine/tenofovir/efavirenz to treat HIV-1 infection, from Gilead Sciences Inc. (GILD), Bristol-Myers Squibb Co. (BMY), and Merck & Co. Inc. (MRK).
Cyanokit: CHMP EPAR for Cyanokit hydoxocobalamin to treat cyanide poisoning, from Merck KGaA (FSE:MRK).
Hycamtin: CHMP revised EPAR to include the risk of neutropenic colitis with Hycamtin topotecan to treat cervical, ovarian and small cell lung cancer, from GlaxoSmithKline plc (LSE:GSK; GSK).
Sutent: CHMP revised EPAR updating the SPC and package leaflet with information on adverse reactions, including some fatalities, reported during post-marketing surveillance for Sutent sunitinib to treat gastrointestinal stromal tumors and metastatic renal cell carcinoma, from Pfizer Inc. (PFE).
Tamiflu: CHMP revised EPAR to include gastrointestinal bleeding in the SPC for Tamiflu oseltamivir to treat and prevent influenza, from Roche (SWX:ROG).
Vectibix: CHMP EPAR for Vectibix panitumumab to treat EGFR-expressing metastatic colorectal cancer in patients whose tumor shows wild-type K-Ras gene expression, from Amgen Inc. (AMGN).

Atopic eczema (December 17, 2007)
NICE guidance on the management of atopic eczema (atopic dermatitis) in children from birth to 12 years of age.

CHMP (PDF file) (December 17, 2007)
Summary of actions taken at the Dec. 10-13 meeting of EMEA's Committee for Medicinal Products for Human Use.

EMEA experts (PDF files) (December 17, 2007)
List of experts involved in the EMEA's peer review evaluation system, sorted by nominating authority and by surname.

Gene/cell therapies (PDF file) (December 17, 2007)
New EU rules covering the authorization, supervision and pharmacovigilance of treatments based on genes, cells or tissues, published in the Official Journal of the European Union.

Obesity (PDF files) (December 17, 2007)
CHMP guidance for the clinical evaluation of new medicinal products to promote weight loss in obese adults and an addendum on weight control in children.

CIRM (PDF file) (December 17, 2007)
Announcement by the Independent Citizens' Oversight Committee (ICOC) of the California Institute for Regenerative Medicine's (CIRM) naming grantees for more than $54 million to support stem cell research by new faculty members for up to five years (see BioCentury Extra, Wednesday, Dec. 12).

Product documentation (December 17, 2007)
— Champix: EMEA Q&A concluding a label revision is needed to warn that cases of suicidal ideation and suicide attempt have been reported in patients receiving Champix varenicline to assist in smoking cessation, from Pfizer Inc. (PFE). (PDF files)
CoAprovel: CHMP revised EPAR updating the SPC to include information on clinical data for CoAprovel (Karvezide) irbesartan/hydrochlorothiazide as first-line treatment for severe hypertension, from Bristol-Myers Squibb Co. (BMY) and sanofi-aventis Group (Euronext:SAN; SNY). (PDF file)
Exjade: Dear Healthcare Professional letter noting changes to the warnings, adverse reactions and dosage and administration sections of the label following postmarketing reports of hepatic failure, some of which were fatal, in patients receiving Exjade deferasirox to treat chronic iron overload due to blood transfusions, from Novartis AG (NVS; SWX:NOVN). (PDF file)
Hepsera: CHMP revised EPAR amending the recommended dosing intervals for patients with renal impairment for Hepsera adefovir to treat HIV infection, from Gilead Sciences Inc. (GILD).
Kiacta: CHMP Q&A regarding its negative opinion on an MAA for Kiacta eprodisate to treat amyloid A (AA) amyloidosis, from Neurochem Inc. (TSX:NRM; NRMX) and Johnson & Johnson (JNJ). (PDF file)
Kynapid: Briefing documents released ahead of the Dec. 11 meeting of FDA's Cardiovascular & Renal Drugs Advisory Committee, which voted 6-2 to recommend approval of an NDA for Kynapid vernakalant for acute conversion of heart arrhythmias, from Cardiome Pharma Corp. (TSX:COM; CRME) and Astellas Pharma Inc. (Tokyo:4503) (see Cover Story).
Lucentis: Amended appraisal consultation document from U.K.'s NICE to amend a decision on the use of Lucentis ranibizumab for wet age-related macular degeneration (AMD) to recommend treatment for the first eye to come to clinical attention, from Novartis AG (NVS; SWX:NOVN) and Genentech Inc. (DNA).
Mevacor: Briefing documents for the Dec. 13 joint meeting of FDA's Drugs and the Endocrinologic and Metabolic Drugs advisory committees, which voted 10-2 to recommend against approving OTC use of Mevacor lovastatin to treat elevated cholesterol, from Merck & Co. Inc. (MRK) and GlaxoSmithKline plc (LSE:GSK; GSK). (PDF file)
Prexige: CHMP Q&A regarding its recommendation that Novartis AG (NVS; SWX:NOVN) withdraw Prexige lumiracoxib, a COX-2 inhibitor to treat osteoarthritis, based on the risk of serious side effects affecting the liver. (PDF file)
Pulzium: Briefing documents released ahead of the Dec. 12 meeting of FDA's Cardiovascular & Renal Drugs Advisory Committee, which voted 7-0 to recommend against approval of an NDA for Pulzium tedisamil for acute conversion of heart arrhythmias, from Solvay S.A. (Euronext:SOLB) (see Cover Story).
Rhucin: CHMP Q&A regarding its negative opinion on an MAA for Rhucin recombinant human complement 1 esterase inhibitor (rhC1INH) to treat acute attacks of hereditary angioedema (HAE), from Pharming Group NV (Euronext:PHARM). (PDF file)

Cancer immunotherapies (PDF file) (December 10, 2007)
CHMP guideline on potency testing of cell-based immunotherapy products to treat cancer.

Product documentation (December 10, 2007)
Actos: CHMP revised EPAR updating the SPC and package leaflet to include information on the risk of bone fractures in female patients treated with Actos pioglitazone to treat Type II diabetes, from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Eli Lilly and Co. (LLY).
Aldurazyme: CHMP revised EPAR updating the SPC to include long-term data from an extension study of Aldurazyme laronidase to treat mucopolysaccharidosis I (MPS-I), from BioMarin Pharmaceutical Inc. (BMRN; SWX:BMRN) and Genzyme Corp. (GENZ).
Avandia: CHMP revised EPAR removing the contraindication of insulin with Avandia rosiglitazone to treat Type II diabetes, from GlaxoSmithKline plc (LSE:GSK; GSK).
Avastin: Briefing documents for the Dec. 5 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 5-4 that the company has not demonstrated a favorable risk-benefit ratio for Avastin bevacizumab plus paclitaxel for first-line treatment of metastatic breast cancer, from Genentech Inc. (DNA) and Roche (SWX:ROG).
Combivir: CHMP revised EPAR extending the indication to include use of Combivir lamivudine/zidovudine to treat HIV infection in pediatric patients, from GlaxoSmithKline plc (LSE:GSK; GSK).
Enbrel: CHMP revised EPAR adding interstitial lung disease as an adverse event in the SPC for Enbrel etanercept to treat rheumatoid arthritis (RA), psoriatic arthritis, plaque psoriasis and ankylosing spondylitis, from Amgen Inc. (AMGN).
Eucreas: CHMP EPAR for Eucreas vildagliptin/metformin to treat Type II diabetes, from Novartis AG (NVS; SWX:NOVN).
Kaletra: CHMP revised EPAR updating the SPC to include information on interaction studies evaluating co-administration of rifampicin and Kaletra lopinavir/ritonavir to treat HIV-1 infections, from Abbott Laboratories (ABT).
Keppra: CHMP revised EPAR updating the SPC to include information on the risk of suicidal attempts for patients receiving Keppra levetiracetam to treat epilepsy and seizures, from UCB Group (Euronext:UCB).
Neulasta: CHMP revised EPAR updating the SPC to include information about injection-site reactions, erythema and flushing associated with use of Neulasta pegfilgrastim to treat neutropenia, from Amgen Inc. (AMGN).
Remicade: CHMP revised EPAR for a label extension for Remicade infliximab, from Johnson & Johnson (JNJ) and Schering-Plough Corp. (SGP) to include ankylosing spondylitis patients who have inadequately responded to conventional therapy.
Torisel: CHMP EPAR for Torisel temsirolimus as first-line treatment for patients with advanced renal cell carcinoma, from Wyeth (WYE).
Viagra: CHMP revised EPAR updating the SPC to include a contraindication for patients with a previous episode of non-arteritic anterior ischemic optic neuropathy for Viagra sildenafil to treat erectile dysfunction, from Pfizer Inc. (PFE).
Xenazine: Briefing documents for the Dec. 6 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which voted 12-0 to recommend approval of an NDA for Xenazine tetrabenazine to treat chorea associated with Huntington's disease, from Prestwick Pharmaceuticals Inc. and Cambridge Laboratories Ltd. (see "Smooth Sailing").

DMARDs (PDF file) (December 3, 2007)
Meta-analysis conducted by the University of North Carolina and colleagues in Annals of Internal Medicine comparing disease-modifying anti-rheumatic drugs (DMARDs) as part of combination therapy and as monotherapies in patients with rheumatoid arthritis (see BioCentury Extra, Monday Nov. 19).

European registration (PDF file) (December 3, 2007)
EMEA reflection paper on criteria for requiring one additional five-year renewal for centrally authorized medicinal products.

FDA reform (PDF file) (December 3, 2007)
Report from the FDA Science Board's subcommittee on science and technology describing deficiencies in the agency's scientific capacity and recommendations on how to make improvements (see BioCentury Extra, Friday Nov. 30).

Smallpox (PDF file) (December 3, 2007)
Draft FDA guidance for developing products to treat or prevent smallpox (see BioCentury Extra, Wednesday Nov. 21).

Product documentation (December 3, 2007)
Aerius: CHMP revised EPAR updating the SPC and package leaflet include conclusions on the provision of further data related to the pediatric population for Aerius desloratadine to treat allergic rhinitis and chronic urticaria, from Schering-Plough Corp. (SGP). (PDF file)
Agenerase: CHMP revised EPAR updating the SPC and package leaflet to remove information related to protease inhibitor-naïve patients and to improve the current information on pre-treated children and on protease inhibitors-experienced adults for Agenerase amprenavir treat HIV-1 with other antiretroviral agents, from GlaxoSmithKline plc (LSE:GSK; GSK). (PDF file)
Arava: CHMP revised EPAR updating the SPC to include renal failure as an adverse reaction for Arava leflunomide to treat rheumatoid arthritis (RA), from sanofi-aventis Group (Euronext:SAN; SNY). (PDF file)
— Ariclaim: CHMP revised EPAR updating the SPC on information regarding gastrointestinal bleeding and withdrawal symptoms, and to update the wording on suicidality for Ariclaim/Yentreve duloxetine to treat moderate to severe stress urinary incontinence in women, from Eli Lilly and Co. (LLY) and Boehringer Ingelheim GmbH. (PDF files)
Avastin: Letter from Sen. Herb Kohl (D-Wis.) to FDA, Genentech Inc. (DNA) and the Centers for Medicare & Medicaid Services (CMS) requesting documents related to meetings and correspondence between DNA and the agency related to any ocular-related applications of Avastin bevacizumab (see BioCentury Extra, Wednesday Nov. 28).
Bondenza: CHMP revised EPAR updating the SPC and package leaflet to include a CHMP class labeling for bisphosphonates of the risk of osteonecrosis of the jaw for Bondenza ibandronic acid to treat osteoporosis in postmenopausal women at increased risk of fracture, from Roche (SWX:ROG). (PDF file)
— Cymbalta: CHMP revised EPAR updating the SPC and package leaflet on information regarding gastrointestinal bleeding and withdrawal symptoms, and updating the wording on suicidality for Cymbalta/Xeristar duloxetine to treat major depressive episodes and diabetic peripheral neuropathic pain, from Eli Lilly and Co. (LLY) and Boehringer Ingelheim GmbH. (PDF file)
Ezetrol: NICE technology appraisal recommending use of Ezetrol ezetimibe on the U.K. National Health Service (NHS) to treat primary hypercholesterolemia, from Merck & Co. Inc. (MRK) and Schering-Plough Corp. (SGP) (PDF file)
Fuzeon: CHMP revised EPAR updating the SPC to include language stating that drug penetration in the cerebrospinal fluid is negligible for Fuzeon enfuvirtide to treat HIV/AIDS, from Roche (SWX:ROG) and Trimeris Inc. (TRMS). (PDF file)
Glivec: CHMP revised EPAR updating the SPC to include information on the observed increase in hepatotoxocity when used in combination with chemotherapy and updating the adverse events on the label for Glivec (Gleevec) imatinib to treat chronic myelogenous leukemia (CML) and gastrointestinal stromal tumors (GIST), from Novartis AG (NVS; SWX:NOVN). (PDF file)
Humira: CHMP revised EPAR updating the SPC to include data from an open-label extension study that showed reduction in rate of progression of structural damage was maintained up to 5 years in a subset of patients receiving Humira adalimumab to treat rheumatoid arthritis (RA), from Abbott Laboratories (ABT). (PDF file)
Noxafil: CHMP revised EPAR updating the SPC to include data from a pharmacokinetic study evaluating four CYP3A4 substrates in combination with Noxafil posaconazole to treat azole-susceptible oropharyngeal Candidiasis infections, from Schering-Plough Corp. (SGP). (PDF file)
Relenza: Briefing documents for the Nov. 27 and 28 meeting of FDA’s Pediatric Advisory Committee to discuss new safety warnings for Relenza zanamivir to treat and prevent influenza from GlaxoSmithKline (LSE:GSK; GSK) (see BioCentury, Dec. 3).
Sprycel: CHMP revised EPAR updating the SPC and package leaflet to include 6-month follow-up data from a pair of ongoing studies for Sprycel dasatinib to treat resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), from Bristol-Myers Squibb Co. (BMY). (PDF file)
Tamiflu: Briefing documents for the Nov. 27 and 28 meeting of FDA’s Pediatric Advisory Committee to discuss new safety warnings for Tamiflu oseltamivir to treat influenza in adults and children from Roche (SWX:ROG) (see BioCentury, Dec. 3).
Tracleer: CHMP revised EPAR updating the SPC and package leaflet to add anemia, decreased hemoglobin, and thrombocytopenia as adverse events based on post-marketing data for Tracleer bosentan to treat pulmonary arterial hypertension (PAH), from Actelion Ltd. (SWX:ATLN). (PDF file)
Viagra: CHMP revised EPAR updating the SPC to include information regarding non-arteritic anterior ischemic optic neuropathy (NAION) and a warning that phosphodiesterase-5 (PDE-5) inhibitors are contraindicated in patients with a previous episode of NAION for Viagra sildenafil to treat erectile dysfunction, from Pfizer (PFE). (PDF file)
Xolair: NICE technology appraisal recommending the use of Xolair omalizumab on the National Health Service (NHS) as an add-on to standard therapy in patients aged 12 years and older severe persistent allergic asthma, from Novartis AG (NVS; SWX:NOVN) and Genentech Inc. (DNA). (PDF file)

Advisory committees (November 19, 2007)
— FDA report on conflict of interest and expertise on advisory committees (see Sacrificing Expertise). (PDF file)
— Draft FDA guidance on the voting procedure for its advisory committees that seek to make the process more transparent and consistent (see BioCentury Extra, Thursday, Nov. 15).
— Draft FDA guidance on public availability of advisory committee members' financial interest information and waivers. (PDF file)

CHMP (PDF file) (November 19, 2007)
Summary of actions taken at the Nov. 12-15 meeting of EMEA's Committee for Medicinal Products for Human Use.

ESAs (PDF file) (November 19, 2007)
Formal request from Amgen Inc. (AMGN) asking the Centers for Medicare & Medicaid Services (CMS) to reconsider its final National Coverage Determination (NCD) on use of erythropoiesis-stimulating agents in non-renal indications (see BioCentury Extra, Wednesday, Nov. 14).

MAAs (PDF file) (November 19, 2007)
Draft CHMP document outlining indications and instances in which a marketing authorization application (MAA) must be submitted under the centralized procedure.

Pain (PDF file) (November 19, 2007)
EMEA Q&A for its recommendation to suspend marketing authorizations for carisoprodol-containing medicinal products to treat back pain, based on a revised risk-benefit assessment.

Post-marketing (PDF file) (November 19, 2007)
MEA standard operating procedure on marketing status reporting and sunset clause monitoring.

Product documentation (PDF files) (November 19, 2007)
Alimta: CHMP revised EPAR updating the SPC and package leaflet to include information regarding cases of radiation pneumonitis, colitis and interstitial pneumonitis in patients treated with Alimta pemetrexed for non-small cell lung cancer (NSCLC), from Eli Lilly and Co. (LLY).
Axura: CHMP revised EPAR updating the SPC to include data from three drug interaction studies for Axura (Namenda) memantine to treat moderate to severe Alzheimer's disease, from H. Lundbeck A/S (CSE:LUN); Forest Laboratories Inc. (FRX); Merz Pharma KGaA; and Neurobiological Technologies Inc. (NTII).
Azilect: CHMP revised EPAR updating the SPC, label and package leaflet to reflect the occurrence of hallucinations and psychosis in patients taking Azilect rasagiline to treat idiopathic Parkinson's disease, from Teva Pharmaceutical Industries Ltd. (TEVA), Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and H. Lundbeck A/S (CSE:LUN).
CellCept: CHMP revised EPAR updating the SPC, label and package leaflet to include information on congenital malformations reported in children of patients exposed to CellCept mycophenolate mofetil, in combination with other immunosuppressants, during pregnancy to treat acute transplant rejection in patients receiving allogeneic transplants, from Roche (SWX:ROG).
Cimzia: CHMP Q&A on its recommendation for the refusal of marketing authorization for Cimzia certolizumab pegol to treat severe, active Crohn's disease, from UCB Group (Euronext:UCB).
Hycamtin: CHMP revised EPAR updating the SPC, label and package leaflet to include information on the risk of neutropenic colitis in patients treated with Hycamtin topotecan to treat recurrent ovarian, small cell lung cancer and recurrent cervical carcinoma, from GlaxoSmithKline plc (LSE:GSK; GSK).
Nexavar: CHMP revised EPAR updating the SPC, label and package leaflet to include information on potential interaction of Nexavar sorafenib with docetaxel to treat advanced renal cell carcinoma (RCC), from Onyx Pharmaceuticals Inc. (ONXX) and Bayer AG (FSE:BAY).
Protelos: EMEA recommendation for changes in the product information to warn of the risk of severe hypersensitivity reactions to Protelos/Osseor to treat postmenopausal osteoporosis, from Servier.
Tysabri: CHMP's Q&A on recommendation for the refusal of marketing authorization for Tysabri natalizumab to treat severe, active Crohn's disease from Biogen Idec Inc. (BIIB) and Elan Corp. plc (ELN).

ESAs (November 12, 2007)
— "Erythropoietin or Darbepoetin for patients with cancer," published in the Cochrane Database of Systematic Reviews.

Risk Communication Advisory Committee (November 12, 2007)
List of the 15 voting members selected to serve on FDA's Risk Communication Advisory Committee, which is to advise the agency on strategies and programs designed to communicate the risks and benefits of FDA-regulated products (see BioCentury Extra, Monday, Nov. 5).

Product documentation (November 12, 2007)
Aptivus: CHMP revised EPAR to update the SPC based on a pharmacokinetic drug-drug interaction study between efavirenz and Aptivus tipranavir/ritonavir to treat HIV infection, from Boehringer Ingelheim GmbH.
Avastin: CHMP revised EPAR to include information relating to fistulae cases and clarify instructions on the dilution of Avastin bevacizumab to treat colorectal and non-small cell lung cancer, from Roche (SWX:ROG) and Genentech Inc. (DNA).
Exjade: CHMP revised EPAR to add warning statements to the SPC on adverse drug reactions for Exjade deferasirox to treat chronic iron overload due to blood transfusions, from Novartis AG (NVS; SWX:NOVN).
Telzir: CHMP revised EPAR updating the SPC based on a methadone drug-drug interaction study of ritonavir and Telzir fosamprenavir to treat HIV, from GlaxoSmithKline plc (LSE:GSK; GSK) and Vertex Pharmaceuticals Inc. (VRTX).
Zevalin: CHMP revised EPAR updating the SPC to include a warning that close monitoring for evidence of extravasation is required in order to avoid radiation-associated tissue damage with use of Zevalin ibritumomab tiuxetan to treat B cell non-Hodgkin's lymphoma, from Bayer AG (FSE:BAY; BAY), Biogen Idec Inc. (BIIB) and Cell Therapeutics Inc. (CTIC; NMerc:CTIC).
Zometa: CHMP revised EPAR updating the SPC and package leaflet to include information on atrial fibrillation and overdose associated with Zometa zoledronic acid to treat bone metastases and bone complications in cancer patients, from Novartis AG (NVS; SWX:NOVN).

Biosimilars (PDF file) (November 5, 2007)
Draft EMEA guideline for the development of biosimilar interferon alpha-2a and alpha-2b products (see BioCentury Extra, Wednesday Oct. 31).

DNA vaccines (PDF file) (November 5, 2007)
FDA guidance on the manufacturing, preclinical development and clinical testing of DNA vaccines to prevent infectious diseases.

Drug importation (PDF file) (November 5, 2007)
U.S. Government of Accountability Office (GAO) report containing preliminary findings of deficiencies in FDA's procedure for inspecting ex-U.S. drug manufacturing facilities.

HIV (PDF files) (November 5, 2007)
Draft EMEA guideline on the clinical development of therapeutics to treat HIV infection.
FDA guidance on the role of HIV resistance testing during antiretroviral drug development and marketing.

Product documentation (November 5, 2007)
Acomplia: CHMP revised EPAR updating the SPC, label and package leaflet to include additional information on psychiatric safety and adding a contraindication for patients with major depression for Acomplia/Zimulti rimonabant to treat obesity, from sanofi-aventis Group (Euronext:SAN; SNY).
CellCept: Dear Health Care Professional letter warning of an increased risk pregnancy loss and congenital malformations associated with CellCept mycophenolate mofetil to prevent organ transplant rejection, from Roche (SWX:ROG). (PDF file)
Garenoxacin: CHMP refusal assessment report for Garenoxacin mesylate to treat to treat acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia (CAP), uncomplicated and complicated skin and skin structure infections and complicated intra-abdominal infections, from Schering-Plough Corp. (SGP). (PDF file)
Genasense: CHMP refusal assessment report for Genasense oblimersen to treat advanced or metastatic melanoma, from Genta Inc. (GNTA). (PDF file)
Retisert: CHMP refusal assessment for Retisert fluocinolone intravitreal implant to treat chronic non-infectious posterior uveitis, from Bausch & Lomb Inc. (BOL). (PDF file)
Viracept: CHMP revised EPAR updating the SPC and package leaflet with results from a study showing that co-administration with omeprazole leads to lower blood levels of the active metabolite of Viracept to treat HIV infection, from Pfizer Inc. (PFE) and Roche (SWX:ROG).
Zalasta: CHMP EPAR for Zalasta/Zyprexa olanzapine to treat schizophrenia and bipolar disorder, from Eli Lilly and Co. (LLY).

Anthrax (PDF file) (October 29, 2007)
U.S. Government Accountability Office (GAO) Project BioShield post-mortem on the problems relating to the anthrax vaccine contract with VaxGen Inc. (VXGN).

ESAs (October 29, 2007)
— Updated joint guideline by The American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO) on the use of erythropoiesis-stimulating agents for chemotherapy-related anemia (see "Trial Doesn't Fix Tribulations").
— New policy from Aetna Inc. regarding its coverage of ESAs (see BioCentury Extra, Friday, Oct. 19).
— A resolution introduced by Sen. Max Baucus (D-Mont.) seeking to nullify the National Coverage Decision (NCD) from the Centers for Medicare & Medicaid Services (CMS) on ESAs for cancer and related neoplastic conditions (see BioCentury Extra, Monday, Oct. 22).

Medicare (October 29, 2007)
Medicare Prescription Drug Savings and Choice Act introduced by Sen. Richard Durbin (D-Ill.), along with Reps. Marion Berry (D-Ark.) and Jan Schakowsky (D-Ill.) calling for the HHS Secretary to create one or more nationally available, Medicare-operated drug plans that would negotiate with pharmaceutical companies on the price of drugs and compete with existing private prescription drug plans (see BioCentury Extra, Wednesday, Oct. 24).

User fees (PDF files) (October 29, 2007)
— FDA notice describing the new direct-to-consumer user fee program established by the FDA Amendments Act of 2007 and requesting companies report how many reviews they will seek during fiscal 2008 in order to establish an appropriate review fee.

Product documentation (October 29, 2007)
Aclasta: CHMP revised EPAR updating SPC and package leaflet to include safety data and to extend the label to include treatment of osteoporosis in postmenopausal women at increased risk of fracture, from Novartis AG (NVS; SWX:NOVN).
Globorix: CHMP statement and related Q&A on the withdrawal of an MAA for Globorix combination vaccine to immunize against diphtheria, tetanus, pertussis, hepatitis B, and certain types of influenza and meningitis, from GlaxoSmithKline plc (LSE:GSK; GSK).
NovoRapid: CHMP revised EPAR to include data from three studies, information about usage during pregnancy, in elderly and patients with renal and hepatic impairment, and recommendations for changes of the injection site for NovoLog insulin aspart in the treatment of Type II diabetes, from Novo Nordisk A/S (NVO).
Prevenar: CHMP revised EPAR to include information from preclinical dose toxicity studies for Prevenar to prevent infection by streptococcus pneumoniae, from Wyeth (WYE).
— Trasylol: FDA warning letter (PDF file) describing higher incidences of mortality in patients seen in a clinical trial of Traysylol aprotonin, which is approved to reduce blood loss and the need for blood transfusion in high-risk patients undergoing cardiopulmonary bypass in the course of CABG surgery, from Bayer AG (FSE:BAY; BAY) (see BioCentury Extra, Thursday, Oct. 25).

CHMP (PDF file) (October 22, 2007)
Summary of actions taken at the October meeting of EMEA's CHMP, which issued a total of 11 positive opinions and one negative opinion for approved or investigational products (see BioCentury Extra, Friday, Sept. 21).

CMS (October 22, 2007)
Centers for Medicare & Medicaid Services national coverage determination (NCD) on its policies for covering the clinical trial expenses of Medicare beneficiaries (see BioCentury Extra, Wednesday, Oct. 17).

ESAs (PDF files) (October 22, 2007)
Letter from Joseph Bailes, chair of the government relations council of the American Society of Clinical Oncology (ASCO), to HHS Secretary Michael Leavitt regarding CMS's National Coverage Decision on ESAs.

Orphan drugs (PDF file) (October 22, 2007)
Summary of actions taken at the October meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Product documentation (October 22, 2007)
Actos: CHMP Q&A on a recommended label change to warn of an association with increased risk of ischemic heart disease in patients taking Actos pioglitazone to treat Type II diabetes, from Eli Lilly and Co. (LLY) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). (PDF file)
Avandia: CHMP Q&A on a recommended label change to warn of an association with increased risk of ischemic heart disease in patients taking Avandia rosiglitazone to treat Type II diabetes, from GlaxoSmithKline plc (LSE:GSK; GSK). (PDF file)
Celsentri: CHMP EPAR for Celsentri maraviroc to treat CCR5-tropic HIV-1 infection, from Pfizer Inc. (PFE).
Globorix: CHMP notice of a withdrawn MAA for Globorix combination vaccine to immunize against diphtheria, tetanus, pertussis, hepatitis B, and certain types of influenza and meningitis, from GlaxoSmithKline plc (LSE:GSK; GSK). (PDF file)
Stalevo: CHMP revised EPAR updating the SPC, product labeling and package leaflet to include information related to the potential side effects of progressive anorexia, asthenia and weight decrease in patients taking Stalevo levodopa/carbidopa/entacapone to treat Parkinson's disease (PD), from Orion Corp. (HSE:ORNAV, ORNBV).
Vfend: CHMP revised EPAR updating the SPC to include increased warning on the potential occurrence of pancreatitis in children taking Vfend voriconazole to treat serious infections, from Pfizer Inc. (PFE).
Zavesca: CHMP Q&A on a refusal to expand use of Gaucher's disease drug Zavesca miglustat to treat Niemann-Pick type C disease, from Actelion Ltd. (SWX:ATLN). (PDF file)

Genome research (October 15, 2007)
Groups receiving grants totaling more than $80 million from NIH's National Human Genome Research Institute (NHGRI) to expand the Encyclopedia of DNA Elements (ENCODE) project.

Phosphate binders (PDF file) (October 15, 2007)
Draft questions for the Oct. 16 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss whether adequate evidence of clinical benefit exists to warrant extending the use of phosphate binders from the dialysis population to include pre-dialysis patients (see BioCentury Extra, Friday Oct. 12).

Radiopharmaceuticals (PDF file) (October 15, 2007)
Draft CHMP guideline describing information required for marketing applications radiopharmaceutical agents.

Product documentation (October 15, 2007)
— Avastin: Letter (PDF file) from Genentech Inc. (DNA) notifying the retinal community that compounding pharmacies will no longer be allowed to purchase Avastin bevacizumab in an effort to limit off-label use of the cancer drug to treat wet age-related macular degeneration (AMD) and other ocular diseases (see "Genentech's Avastin Gambit"); and a CHMP revised EPAR expanding Avastin's label in Europe to include first-line treatment of unresectable advanced, metastatic or recurrent non-small cell lung cancer, from Roche (SWX:ROG).
Bondronat: CHMP revised EPAR to reduce the currently approved infusion time from 1 hour to 15 minutes for Bondronat ibandronic acid to treat skeletal events in patients with breast cancer and bone metastases, from Roche (SWX:ROG).
Ecalta: CHMP EPAR for Ecalta (Eraxis) anidulafungin to treat invasive candidiasis, from Pfizer Inc. (PFE).
Emselex: CHMP revised EPAR to include urinary retention and blurred vision as uncommon adverse drug reactions for Emselex darifenacin to treat symptoms of overactive bladder (OAB), from Novartis AG (NVS; SWX:NOVN).
Emtriva: CHMP revised EPAR to list anemia as an adverse reaction for Emtriva emtricitabine to treat HIV infection, from Gilead Sciences Inc. (GILD).
Faslodex: CHMP revised EPAR to update the SPC to include data from a study on hepatic impairment associated with Faslodex fulvestrant to treat advanced breast cancer in postmenopausal women with estrogen receptor-positive locally advanced or metastatic breast cancer and in disease relapse on or after anti-estrogen therapy or disease progression on therapy with an anti-estrogen compound, from AstraZeneca plc (LSE:AZN; AZN).
Inovelon: CHMP revised EPAR updating the SPC with data from a study that suggested a decrease in QTc interval was associated with use of Inovelon rufinamide as an adjunctive therapy to treat Lennox-Gastaut syndrome (LGS) in children, from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).
MabThera: CHMP revised EPAR updating the SPC with information on the risk of progressive multifocal leukoencephalopathy (PML) associated with use of MabThera (Rituxan) rituximab to treat follicular lymphoma and CD20 positive diffuse large B cell non-Hodgkin's lymphoma (NHL), from Roche (SWX:ROG).
NovoSeven: CHMP revised EPAR updating the SPC to include results from pharmacokinetics studies for NovoSeven recombinant human coagulation Factor VIIa to treat hemophilia A or B patients with antibodies to Factors VIII or IX; to treat bleeding in patients with acquired hemophilia; and to prevent bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia, from Novo Nordisk A/S (CSE:NVO; NVO).
Photobarr: CHMP revised EPAR updating the SPC to include further recommendations for patients with hepatic impairment for Photobarr photodynamic therapy (PDT) to treat high-grade dysplasia associated with Barrett's esophagus, from Axcan Pharma Inc. (TSE:AXP; AXCA).
Rebif: CHMP revised EPAR to include information regarding the use of Rebif interferon beta-1a in pediatric patients with multiple sclerosis (MS), from Merck KGaA (FSE:MRK).
RotaTeq: CHMP revised EPAR to update theSPC to include the risk of Kawasaki Disease associated with use of RotaTeq rotavirus vaccine, from sanofi-aventis Group (Euronext:SAN; SNY) and Merck & Co. Inc. (MRK).
Tarceva: CHMP revised EPAR to include information on the interactions with omeprazole or ciprofloxacin and Tarceva erlotinib treat advanced non-small cell lung cancer (NSCLC), from Roche (SWX:ROG).
Ventavis: CHMP revised EPAR to update the SPC with addition of peripheral edema as an adverse reaction associated with use of Ventavis iloprost to treat peripheral arterial hypertension (PAH), from CoTherix Inc. (CTRX) and Bayer AG (FSE:BAY; BAY).
Yondelis: CHMP EPAR for Yondelis trabectedin to treat soft tissue sarcoma, from PharmaMar S.A.
Zerene: CHMP revised EPAR updating the SPC to include warning on the risk of dependence associated with Zerene (Sonata) zaleplon to treat insomnia, from Wyeth (WYE) and Meda AB (SSE:MEDA).

Critical Path (PDF file) (October 8, 2007)
FDA request for nominations for members of the board of directors of the Reagan-Udall Foundation, a non-profit foundation to coordinate and expand public-private collaborative research on product development and safety (see BioCentury Extra, Monday Oct 1).

Product documentation (October 8, 2007)
Cervarix: CHMP EPAR for Cervarix human papillomavirus (HPV) vaccine to prevent precancerous lesions and cervical cancer, from GlaxoSmithKline plc (LSE:GSK; GSK).
Galvus: CHMP EPAR for Galvus vildagliptin to treat Type II diabetes, from Novartis AG (NVS; SWX:NOVN).
NovoSeven: CHMP revised EPAR updating the SPC with data from two pharmacokinetic studies suggesting dose proportionality across sex and ethnic groups for NovoSeven recombinant Factor VIIa to treat bleeding episodes and to prevent bleeding during surgery, from Novo Nordisk A/S (CSE:NVO; NVO).
Stocrin: CHMP revised EPAR to include a reference to the possibility of increased exposure to HIV drug Stocrin efavirenz in patients carrying the CYP2B6 516 TT genetic polymorphism, from Merck & Co. Inc. (MRK).
Sustiva: CHMP revised EPAR to include a reference to the possibility of increased exposure to HIV drug Sustiva efavirenz in patients carrying the CYP2B6 G516T genetic polymorphism, from Bristol-Myers Squibb Co. (BMY, Princeton, N.J.).
Trizivir: CHMP revised EPAR to update the SPC to discourage the maintenance of Triziver abacavir sulfate/lamivudine/zidovudine in the presence of M184V mutation when other active NRTIs are available to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; GSK),
Ziagen: CHMP revised EPAR to include on the SPC that pharmacokinetic parameters of CBV-TP were higher with the Ziagen abacavir once-daily regimen than with the twice-daily regimen to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; GSK).

Centralized procedure (PDF file) (October 1, 2007)
Draft EMEA discussion paper regarding working definitions for diseases that require regulatory review under the EC's centralized procedure.

PDUFA (October 1, 2007)
— Full text of the FDA Amendments Act of 2007 (FDAAA, H.R. 3580), which was signed into law by President Bush (see BioCentury, Sept. 24). (PDF file)
— FDA notice of fee rates for marketing applications submitted on or after Oct. 1 according to FDAAA.

Vaccines (PDF file) (October 1, 2007)
FDA guidance on conducting preventative vaccine clinical trials in healthy volunteers, including recommendations for assessing the severity of clinical and laboratory abnormalities.

Product documentation (October 1, 2007)
Enbrel: CHMP revised EPAR updating the SPC and annex II to reflect studies showing no significant drug-drug interactions resulting from digoxin or warfarin use in patients taking Enbrel etanercept to treat a variety of autoimmune diseases, from Wyeth (WYE).
Gliolan: CHMP EPAR for Gliolan 5-aminolevulinic acid hydrochloride to help visualize malignant tissue during surgery for malignant glioma, from Medac GmbH.
Telzir: CHMP revised EPAR updating the SPC, package leaflet and annex II to expand the label for Telzir fosamprenavir calcium to include treatment of HIV in patients as young as six years old, from GlaxoSmithKline plc (LSE:GSK; GSK).

CHMP (PDF file) (September 24, 2007)
Summary of actions taken at the September meeting of EMEA's CHMP, which issued a total of 12 positive opinions and two negative opinions on new indications for either approved or investigational products (see BioCentury Extra, Friday, Sept. 21).

In vitro diagnostics (PDF file) (September 24, 2007)
FDA notice that it has extended through Oct. 17 the period for accepting comments on the draft guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs).

Metered-dose inhalers (PDF file) (September 24, 2007)
FDA proposed rule to remove the "essential use" designation for metered-dose inhalers that deliver epinephrine by means of CFCs.

Stem cells (September 24, 2007)
NIH plan for implementing an executive order by President Bush that calls for exploring methods for expanding approved pluripotent stem cell lines for research (see BioCentury Extra, Wednesday, Sept. 19). (PDF file)

Product documentation (September 24, 2007)
Atriance: CHMP EPAR for Atriance nelarabine to treat advanced T cell acute lymphoblastic leukemia (ALL) and T cell lymphoblastic lymphoma (LBL), from GlaxoSmithKline plc (LSE:GSK; GSK).
Isentress: Slides from the Sept. 5 meeting of the agency's Antiviral Drugs Advisory Committee to discuss an NDA for Isentress raltegravir (MK-0518) to treat HIV infection, from Merck & Co. Inc. (MRK) (see BioCentury, Sept. 10).
Mylotarg: CHMP Q&A on its recommendation against granting marketing approval to Mylotarg gemtuzumab ozogamicin to treat acute myelogenous leukemia (AML), from Wyeth (WYE) and UCB Group (Euronext:UCB) (see BioCentury Extra, Thursday Sept 20). (PDF file)
Nutropin AQ: CHMP Q&A on its recommendation against an expanded label for Nutropin AQ somatropin to include long-term treatment of children with severe idiopathic short stature, from Genentech Inc. (DNA) and Ipsen Group (Euronext:IPN). (PDF file)
— Sprycel: CHMP EPAR (PDF file) for the requested update of the SPC to include six-month data from a pair of ongoing Phase III trials of Sprycel dasatanib to treat resistant chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), from Bristol-Myers Squibb Co. (BMY).
Vectibix: CHMP Q&A on the agency's re-examination and subsequent recommendation to grant conditional marketing approval for Vectibix panitumumab to treat EGRF-expressing metastatic colorectal cancer after failure on chemotherapy in patients with KRAS mutation, from Amgen Inc. (AMGN). (PDF file)
Viracept: CHMP Q&A on its recommendation to lift the marketing suspension placed on Viracept nelfinavir to treat HIV infection, from Roche (SWX:ROG) and Pfizer Inc. (PFE). (PDF file)

Analyte specific reagents (PDF file) (September 17, 2007)
FDA guidance clarifying regulations regarding commercially distributed analyte specific reagents (ASRs).

Intellectual property (PDF file) (September 17, 2007)
The U.S. Patent and Trademark Office guidelines stating that a patent application containing more than 5 independent claims or more than 25 total claims will require an examination support document (ESD) unless PTO has sent a first office action by Nov. 1 (see BioCentury, Aug. 27).

Product documentation (September 17, 2007)
Agenerase: CHMP revised EPAR to include the contraindication of co-administration of oral midazolam and Agenerase amprenavir to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; GSK) and Vertex Pharmaceuticals Inc. (VRTX).
Binocrit: CHMP EPAR for three biosimilar versions of epoetin alfa to treat anemia, including Binocrit epoetin alfa from Novartis AG (NVS; SWX:NOVN); Epoetin alfa Hexal from Sandoz's Hexal AG unit; and Abseamed from Medice Arzneimittel Pütter GmbH & Co. KG (see BioCentury Extra, Friday, Sept. 14).
Epivir: CHMP revised EPAR updating the SPC to discourage the use of Epivir lamivudine, from GlaxoSmithKline plc (LSE:GSK; GSK), to treat HIV infection in patients expressing M184V mutation when other nucleoside reverse transcriptase inhibitors are available.
Fentora: "Dear Healthcare Professional" letter from Cephalon Inc. (CEPH) emphasizing appropriate patient selection, dosing and administration for Fentora to manage breakthrough cancer pain in patients who are tolerant to opioid therapy. (PDF file)
Flebogammadif: CHMP EPAR for Flebogammadif replacement therapy in immunodeficiency and for immunomodulation in immune-mediated diseases, from Grifols S.A.
Kivexa: CHMP revised EPAR updating the SPC to discourage the use of Kivexa lamivudine/abacavir, from GlaxoSmithKline plc (LSE:GSK; GSK), to treat HIV infection in patients expressing M184V mutation when other nucleoside reverse transcriptase inhibitors are available.
Rapamune: CHMP revised EPAR updating the SPC to include information on adverse reactions such as exfoliative dermatitis, hypophosphataemia and hyperglycaemia for Rapamune sirolimus to prevent organ rejection in patients receiving renal transplants, from Wyeth (WYE).
Viracept: "Dear Healthcare Professional" letter informing healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity, in Viracept nelfinavir and to provide guidance on the use of Viracept in pregnant women and pediatric patients to treat HIV infection, from Pfizer Inc. (PFE). (PDF file)

ESAs (PDF file) (September 10, 2007)
FDA briefing documents for the Sept. 11 joint meeting of the agency's Cardiovascular and Renal Drugs and Drug Safety and Risk Management advisory committees to discuss safety considerations related to the use of erythropoiesis-stimulating agents to treat anemia associated with chronic renal failure (see Ebb & Flow).

Pharmacogenomics (September 10, 2007)
NIH's dbGap database designed to archive and distribute the results of genomewide association studies investigating the interaction of genotype and phenotype.

Spore-forming microorganisms (PDF file) (September 10, 2007)
FDA guidance providing modified requirements for using spore-forming microorganisms to manufacture biological intermediates and drug substances.

Product documentation (September 10, 2007)
Aptivus: CHMP revised EPAR updating the SPC based on the results of a study assessing the pharmacokinetics of carbamazepine administered alone or in combination with Aptivus tipranavir to treat HIV infection, from Boehringer Ingelheim GmbH.
Crixivan: CHMP revised EPAR updating the SPC to include a contraindication against co-administration of oral midazolam and a warning that caution should be used with injectable midazolam in combination with Crixivan indinavir sulphate to treat HIV infection, from Merck & Co. Inc. (MRK).
Ebixa: CHMP revised EPAR updating the SPC to include results from three drug interaction studies evaluating the effect of glyburide/metformin, donepezil or galantamine in combination with Ebixa memantine to treat moderate to severe Alzheimer's disease (AD), from H. Lundbeck A/S (CSE:LUN).
Kaletra: CHMP revised EPAR to include a contraindication against co-administration of oral midazolam and a warning that caution should be used with injectable midazolam in combination with Kaletra lopinavir/ritonavir to treat HIV infection, from Abbott Laboratories (ABT).
NeuroBloc: CHMP revised EPAR to include the final results of a post-marketing study comparing the safety and efficacy of Botox botulinum toxin type A and NeuroBloc botulinum toxin type B to treat cervical dystonia pain, from Solstice Neurosciences Inc.
Norvir: CHMP revised EPAR to include a contraindication against co-administration of oral midazolam and a warning that caution should be used with injectable midazolam in combination with Norvir ritonavir, from Abbott Laboratories (ABT).
Prezista: CHMP revised EPAR updating the SPC and package leaflet to include a contraindication against the use of lopinavir/ritonavir with Prezista darunavir to treat HIV infection, from Johnson & Johnson (JNJ).
Rasilez: CHMP EPAR for Rasilez aliskiren to treat hypertension, from Novartis AG (NVS; SWX:NOVN) and Speedel (SWX:SPPN).
RotaTeq: CHMP revised EPAR updating the SPC to include concomitant administration of oral poliovirus vaccine and RotaTeq to prevent rotavirus gastroenteritis, from sanofi-aventis Group (Euronext:SAN; SNY) and Merck & Co. Inc. (MRK).
Sustiva/Stocrin: CHMP revised EPAR to include a reference to the possibility of increased drug exposure in patients expressing certain genetic polymorphisms when receiving Sustiva/Stocrin efavirenz to treat HIV infection, from Bristol-Myers Squibb Co. (BMY) and Merck & Co. Inc. (MRK).
Velcade: NICE final appraisal determination stipulating conditions for use of Velcade bortezomib monotherapy on the National Health Service (NHS) to treat multiple myeloma (MM), from Johnson & Johnson (JNJ) and Millennium Pharmaceuticals Inc. (MLNM) (see NICE's Velcade Gotcha).
Ziagen: CHMP revised EPAR to include the results of a study showing the pharmacokinetic parameters of a once-daily dosing regimen were higher than for a twice-daily regimen for Ziagen abacavir to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; GSK).

Asthma (PDF file) (September 3, 2007)
Guidelines from the NIH's National Heart, Lung, and Blood Institute under its National Asthma Education and Prevention Program for the diagnosis and management of asthma.

Peer Review (September 3, 2007)
NIH notice of meetings on Oct. 8 and Oct. 25 to obtain comment on the NIH Peer Review System.

Pharmacogenomics (PDF file) (September 3, 2007)
Draft FDA companion guidance to be used with the 2005 guidance on pharmacogenomic data submissions related to voluntary genomic data submissions as well as data and protocols submitted as part of an IND, NDA or BLA.

Product documentation (September 3, 2007)
Isentress: FDA briefing documents for the Sept. 5 meeting of the agency's Antiviral Drugs Advisory Committee to discuss an NDA for Isentress raltegravir (MK-0518), from Merck & Co. Inc. (MRK). (PDF file)
Lantus: CHMP revised EPAR updating the SPC and package leaflet for Lantus insulin glargine to include safety information on Type II diabetes patients <=18 years of age, from sanofi-aventis Group (Euronext:SAN; SNY).
Telzir: CHMP revised EPAR contraindicating the co-administration of orally administered midazolam and Telzir (Lexiva) fosamprenavir to treat HIV infection, from GlaxoSmithKline plc (LSE:GSK; GSK).
Xolair: CHMP revised EPAR updating the SPC to include adverse reactions including allergic reactions, worsening pulmonary symptoms and cardiac complications for Xolair omalizumab to treat allergic asthma, from Novartis AG (NVS; SWX:NOVN) and Genentech Inc (DNA).

Advertising (PDF file) (August 27, 2007)
FDA request for comment on a study to evaluate consumer understanding of risk and benefit information in broadcast direct-to-consumer (DTC) prescription drug advertisements.

Patents (PDF files) (August 27, 2007)
Final U.S. PTO rule limiting claims and continuations for patents and and accompanying presentation on the rules (see BioCentury, Aug. 27).

Product documentation (August 27, 2007)
-- Aclasta: CHMP revised EPAR updating the SPC and package leaflet to include hypersensitivity to biphosphonates, injection site reactions, and iritis/ uveitis/ episcleritis/ conjunctivitis as side effects in patients taking Aclasta zoledronic acid to treat Paget’s disease of the bone, from Novartis AG (NVS; SWX:NOVN).
-- Advate: CHMP revised EPAR updating the SPC and package leaflet to include a warning on potential development of inhibitors when patients switch either to or from hemophilia treatment Advate octocog alfa, from Baxter International Inc. (BAX) (see BioCentury, Aug. 20).
-- Aptivus: CHMP revised EPAR recommending caution when co-administering carbamazepine with Aptivus tipranavir to treat HIV, from Boehringer Ingelheim GmbH.
-- Avandia: Transcripts from the July 30 joint meeting of FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees to discuss cardiovascular safety signals associated with use of Avandia rosiglitazone to treat Type II diabetes, from GlaxoSmithKline plc (LSE:GSK; GSK) (see BioCentury, Aug. 6). (Part 1) (Part 2) (Part 3) (Part 4) (Part 5) (PDF files)
-- CellCept: CHMP revised EPAR for transplant drug CellCept mycophenolate mofetil to include information on the signs and symptoms of overdose and on treatment of overdose, from Roche (SWX:ROG).
-- Humira: CHMP revised EPAR for Humira adalimumab to include results from an extension study in rheumatoid arthritis (RA)
-- Prandin: CHMP revised EPAR updating the SPC, labeling and package leaflet with results from an epidemiological study to quantify the potential cardiovascular risk of Prandin repaglinide to treat Type II diabetes, from Novo Nordisk (CSE:NVO; NVO).
-- Revatio: Notice of an Oct. 17 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss data requirements and study designs appropriate to characterize the durability of treatment effect of Revatio sildenafil citrate in pulmonary arterial hypertension (PAH) in children, from Pfizer Inc. (PFE). (PDF file)
-- Trasylol: Notice of a Sept. 12 joint meeting of FDA's Cardiovascular and Renal Drugs and the Drug Safety and Risk Management advisory committees to discuss possible safety signals associated with use of Trasylol aprotinin to reduce peri-operative blood loss, from Bayer AG (FSE:BAY; BAY). (PDF file)
-- Vfend: CHMP revised EPAR updating the SPC of Vfend voriconazole, an antifungal, to add the monitoring of amylase in children and cases of pancreatitis in children, from Pfizer Inc. (PFE).
-- Warfarin: FDA release highlighting updates in the labeling of warfarin, a generic drug used to thin the blood, to include information on genetic factors that can be used to predict optimal dosing.

Drug exportation (PDF file) (August 20, 2007)
FDA notice soliciting comments on guidance regarding the exportation of human and animal drugs, biologics, devices, food and dietary supplements under the Export Reform and Enhancement Act of 1996.

Factor VIII (August 20, 2007)
EMEA draft guideline on the clinical investigation of recombinant Factor VIII and IX products (see Cover Story). (PDF file)
EMEA report of expert meeting on Factor VIII products and inhibitor development. (PDF file)
Kogenate: CHMP revised EPAR updating the SPC and package leaflet for Kogenate octocog alfa to include warnings of possible inhibitor recurrence when switching patients, in certain cases, to or from another recombinant coagulation factor VIII products, from Bayer AG (FSE:BAY; BAY).

Osteoarthritis (PDF file) (August 20, 2007)
FDA notice requesting additional information on issues related to clinical development programs for drugs, biological products and medical devices to treat and prevent osteoarthritis, which will be used to complete draft guidance issued in 1999.

Pre-submission (PDF file) (August 20, 2007)
EMEA pre-submission guidance on issues concerning the centralized procedure that are typically addressed at pre-submission meetings between the agency and sponsor.

Tissue allografts (PDF file) (August 20, 2007)
FDA notice of Oct. 11-12 workshop to discuss methods used to process tissue allograft, pre- and post-processing cultures, and disinfection and sterilization of tissues.

Product documentation (August 20, 2007)
Gardasil: CHMP revised EPAR updating the SPC and package leaflet of the HPV vaccine Gardasil to include adverse reactions, including syncope, dizziness and nausea, from sanofi-aventis Group (Euronext:SAN; SNY) and Merck & Co. Inc. (MRK) .
Increlex: CHMP EPAR for Increlex mecasermin to treat growth failure in children and adolescents with severe primary IGF-1 deficiency (IGFD), from Ipsen Group (Euronext:IPN) and Tercica Inc. (TRCA).
NovoNorm: CHMP revised EPAR updating the SPC to include the potential cardiovascular risk of NovoNorm repaglinide to treat Type II diabetes, from Novo Nordisk A/S (CSE:NVO; NVO).
Stocrin/Sustiva: CHMP revised EPAR updating the SPC and package leaflet to include a recommendation on dose adjustment for co-administration of voriconazole and Stocrin/Sustiva efavirenz from Bristol-Myers Squibb Co. (BMY) and Merck & Co. Inc. (MRK).
Tarceva: CHMP revised EPAR updating the SPC and package leaflet to include information on interactions of omeprazole and ciprofloxacin with Tarceva erlotinib to treat pancreatic cancer and non-small cell lung cancer (NSCLC), from Roche (SWX:ROG), Genentech Inc. (DNA) and OSI Pharmaceuticals Inc. (OSIP).
Viracept: CHMP revised EPAR following the MAA suspension of Viracept nelfinavir treat HIV infection due to manufacturing contaminants, from Pfizer Inc. (PFE).

Reimportation (PDF file) (August 13, 2007)
Text of the House 2008 appropriations bill (H.R. 3161), as passed to the Senate, that includes a provision that would permit importation of prescription drugs (see BioCentury Extra, Monday, Aug. 6).

Product documentation (August 13, 2007)
— Avandia: Presentations from the July 30 joint meeting of FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees to discuss cardiovascular safety signals associated with Avandia rosiglitazone (see BioCentury, Aug. 6), and a CHMP revised EPAR updating the SPC and package leaflet to include warnings of increased risk of bone fractures in females taking Avandia to treat Type II diabetes, from GlaxoSmithKline plc (LSE:GSK; GSK).
Orplatna: Presentations from the July 24 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to discuss an NDA for Orplatna satraplatin to treat patients with hormone-refractory prostate cancer (HRPC) who have failed prior chemotherapy, from GPC Biotech AG (FSE:GPC; GPCB) and Spectrum Pharmaceuticals Inc. (SPPI) (see BioCentury, July 30).
Pergoveris: CHMP EPAR for Pergoveris follitropin alfa/lutropin alfa to stimulate follicle formation in patients with certain hormone deficiencies, from Merck KGaA (FSE:MRK).
Siklos: CHMP EPAR for Siklos hydroxycarbamide to prevent vaso-occlusive crises in patients suffering from symptomatic sickle cell disease, from addmedica S.A.S.
Trazec: CHMP revised EPAR updating the SPC and package leaflet to include the adverse reactions abdominal pain, diarrhea, dyspepsia, nausea and vomiting in patients taking Trazec (Starlix/Starsis) nateglinide to treat Type II diabetes, from Novartis AG (NVS; SWX:NOVN).
Velcade: CHMP revised EPAR updating the SPC, labeling and package leaflet to include possible increased risk of death when co-administering high-dose cytarabine to patients taking Velcade bortezomib to treat progressive multiple myeloma, from Johnson & Johnson (JNJ) and Millennium Pharmaceuticals Inc. (MLNM).
Xenical: CHMP revised EPAR updating the SPC and package leaflet to include warnings of an increased risk of rectal bleeding and unintentional pregnancy in patients taking Xenical orlistat to treat obesity, from Roche (SWX:ROG).

Compassionate use (PDF files) (August 6, 2007)
CHMP guideline on compassionate use of medicinal products, including a summary of comments received on the draft guidance and a related Q&A.

ESAs (August 6, 2007)
Centers for Medicare and Medicaid Services (CMS) final National Coverage Decision (NCD) on erythropoiesis-stimulating agents for cancer and related neoplastic conditions (see BioCentury, August 6, 2007).

Manufacturing (PDF file) (August 6, 2007)
Draft EMEA guidance on comparability of biologics after a change in manufacturing process.

Vaccines (PDF files) (August 6, 2007)
EMEA concept papers covering the development of vaccines incorporating live recombinant vectors and plasmid DNA.

Product documentation (August 6, 2007)
Aerinaze: CHMP EPAR for Aerinaze desloratadine/pseudoephedrine sulfate to treat seasonal allergic rhinitis, from Schering-Plough Corp. (SGP).
Mircera: CHMP EPAR for Mircera to treat anemia associated with chronic kidney disease (CKD), from Roche (SWX:ROG).
Optaflu: CHMP EPAR for Optaflu cell culture influenza vaccine to prevent seasonal influenza in adults, from Novartis AG (NVS; SWX:NOVN).
Optimark: CHMP EPAR for Optimark gadoversetamide to be used as a contrast agent in magnetic resonance imaging (MRI), from Tyco International Inc. (TYC)
Orencia: NICE appraisal consultation recommending against use of Orencia abatacept to treat rheumatoid arthritis (RA), from Bristol-Myers Squibb Co. (BMY) (see BioCentury Extra, Thursday, Aug. 2, 2007).
Rebetol: CHMP revised EPAR updating the SPC and package leaflet to include the adverse reaction of seizure in patients taking Rebetol ribavirin to treat chronic hepatitis C (HCV) infection, from Schering-Plough Corp. (SGP).

Alzheimer's disease (PDF file) (July 30, 2007)
EMEA draft guideline for the clinical development of human medicinal products for AD and other dementias.

Cardiovascular disease (July 30, 2007)
— EMEA draft guideline for the clinical development of human medicinal products for cardiovascular disease. (PDF file)
— Draft NICE guidance covering lipid management for primary and secondary prevention of cardiovascular disease.

Counterterrorism (PDF file) (July 30, 2007)
FDA guidance on the issuing of Emergency Use Authorizations (EUAs) for medicinal products against biological, chemical, radiological and nuclear agents.

Insomnia (PDF file) (July 30, 2007)
EMEA concept paper on the revision of guidelines for the development of hypnotic medicinal products.

In vitro diagnostics (PDF file) (July 30, 2007)
Draft FDA guidance addressing the definition and regulatory status of In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) (see BioCentury, July 30).

Nanotechnology (PDF file) (July 30, 2007)
FDA's task force report on nanotechnology, including how the agency might address regulatory issues involving products incorporating nanoscale materials.

Nicotine dependence (PDF file) (July 30, 2007)
EMEA draft guidance for the clinical development of human medicinal products for nicotine dependence.

Organ transplant (PDF file) (July 30, 2007)
EMEA draft guidance for the clinical development of immunosuppressants for organ transplantation.

Orphan drugs (PDF file) (July 30, 2007)
Summary of actions taken at the July meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Parkinson's disease (PDF file) (July 30, 2007)
EMEA draft guideline for the clinical development of human medicinal products for PD.

Product documentation (July 30, 2007)
— Agreal: CHMP opinion and related Q&A on a recommendation to withdraw marketing authorization due to an unacceptable risk-benefit profile for Agreal/Agradil veralipride to treat hot flushes associated with menopause, from sanofi-aventis Group (Euronext:SAN; SNY). (PDF files)
Avandia: Briefing documents for the July 30 joint meeting of FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees to discuss cardiovascular safety signals associated with diabetes drug Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; GSK) (see BioCentury Extra, Thursday, July 26). (PDF file)
— Cerepro: CHMP statement and related Q&A on the withdrawal of an MAA for Cerepro to treat operable, high-grade glioma, from Ark Therapeutics Group plc (LSE:AKT) (see BioCentury, July 30). (PDF files)
Tysabri: FDA briefing information for the July 31 meeting of the Drug Safety and Risk Management Advisory Committee to discuss an sBLA for Tysabri natalizumab treat moderate to severe active Crohn's disease, from Biogen Idec Inc. (BIIB) and Elan Corp. plc (ELN) (see BioCentury Extra, Friday, July 27).

Centralized procedure (July 23, 2007)
Updated Q&A on EMEA’s pre-submission guidance for marketing applications under the European “Centralized Procedure”.

CHMP (PDF file) (July 23, 2007)
Summary of actions taken at the July 16 meeting of EMEA’s Committee for Medicinal Products for Human Use

Combination products (PDF file) (July 23, 2007)
Draft FDA guidance on the preparation and submission of 510(k) applications for medical devices that include antimicrobial agents.

Orphan drugs (PDF file) (July 23, 2007)
EMEA’s procedure and general principles for Orphan medicinal product designation.

Pediatric drugs (July 23, 2007)
Overview of the European pediatric initiative designed to promote collection of information about use of drug products in pediatric patients. (PDF file)

Product documentation (July 23, 2007)
Abilify: CHMP revised EPAR including information on post-marketing adverse events and a general warning on hypersensitivity for Abilify aripiprazole to treat schizophrenia, from Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768).
— Evista: FDA and company briefing documents for the July 24 meeting of the Oncology Drugs Advisory Committee (ODAC) to discuss an NDA for Evista raloxifene to to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk of breast cancer, from Eli Lilly and Co. (LLY). (PDF files)
Genasense: Q&A on EMEA’s recommendation for refusal of the marketing authorization of Genasense oblimersen to treat metastatic melanoma, from Genta Inc. (GNTA) (see BioCentury Extra, Friday July 20). (PDF file)
Tysabri: Q&A on EMEA’s recommendation for refusal of the marketing authorization of Tysabri natalizumab to treat Crohn’s disease, from Elan Corp. plc (ELN) and Biogen Idec Inc. (BIIB) (see BioCentury Extra, Thursday July 19). (PDF file)
— Orplanta: FDA and company briefing documents for the July 24 meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss an NDA for Orplanta satraplatin to treat patients with hormone-refractory prostate cancer (HRPC) who have failed prior chemotherapy, from GPC Biotech AG (FSE:GPC; GPCB) and Spectrum Pharmaceuticals Inc. (SPPI) (see BioCentury Extra, Friday July 20). (PDF files)
Temodal: CHMP revised EPAR updating the SPC to provide safety information on gender differences in hematologic parameters occurring during the first cycle of treatment in glioma patients receiving Temodal temozolomide, from Schering-Plough Corp. (SGP).
Yentreve: CHMP revised EPAR reflecting new safety information for Yentreve (Ariclaim) duloxetine for women with stress urinary incontinence (SUI), from Eli Lilly and Co. (LLY).
Zometa: CHMP revised EPAR updating SPC to include a precaution on renal dysfunction and to add bronchoconstriction and somnolence to the warning on osteonecrosis for Zometa zoledronic acid to treat malignant hypercalcaemia, from Novartis AG (NVS; SWX:NOVN).

Health claims (PDF file) (July 16, 2007)
Draft FDA guidance on the evidence-based review system for scientific evaluation of health claims for foods, including dietary supplements.

Manufacturing (PDF file) (July 16, 2007)
Draft Q10 guidance from the International Conference on Harmonization (ICH) on the establishment and maintenance of quality control system to ensure production of pharmaceutical drug products.

Parkinson’s disease (July 16, 2007)
A list of awards given by the Michael J. Fox Foundation to academic research teams focused on validating new therapeutics targets for addressing Parkinson’s disease (PD) (see BioCentury Extra, Thursday, July 12).

Partnering (July 16, 2007)
NIH’s Pipeline to Partnership (P2P) website designed to allow licensees and SBIR/STTR awardees a forum to showcase products and technologies for potential partners and investors.

Product documentation (July 16, 2007)
Angiox: CHMP revised EPAR updating the undesirable characteristics section to include intracranial haemmorrhage for Angiox (Angiomax-U.S.) bivalirudin as an anticoagulant in patients undergoing angioplasty or percutaneous coronary intervention (PCI), from The Medicines Co. (MDCO).
Circadin: CHMP EPAR for Circadin melatonin to treat primary insomnia, from Neurim Pharmaceuticals Ltd.
Crixivan: CHMP revised EPAR updating the SPC to add a contraindication for concomitant use of amiodarone with Crixivan indinavir to treat HIV infection, from Merck & Co. Inc. (MRK).
Invega: CHMP EPAR for Invega paliperidone to treat schizophrenia, from Johnson & Johnson (JNJ).
Kaletra: CHMP revised EPAR to update the SPC and package leaflet to include data suggesting no drug-drug interaction with either omeprazole or ranitidine with Kaletra lopinavir/ritonavir to treat HIV infection, from Abbott Laboratories (ABT).
Visudyne: CHMP revised EPAR to update the SPC and package leaflet to remove the indication to treat patients with subfoveal occult CNV due to AMD with evidence of recent or ongoing disease progression for Visudyne verteporfin, from QLT Inc. (TSX:QLT; QLTI) and Novartis AG (NVS; SWX:NOVN).

Innovation (July 9, 2007)
The “Cologne Paper” (PDF file) outlining multiple perspectives of a knowledge-based bio-economy in Europe in 2030, including issues on food, biomaterials and bioprocesses, bioenergy, biomedicine and emerging concepts and technologies; and form for submitting comments.

Pediatrics (PDF file) (July 9, 2007)
Overview of comments received by EMEA regarding its draft guidance on pharmacovigilance for pediatric medicines.

Pharmacokinetics (PDF file) (July 9, 2007)
Draft EMEA guidance and an overview of comments received by the agency regarding the reporting of results from population pharmacokinetic analyses.

Product documentation (July 9, 2007)
Humira: CHMP revised EPAR updating the SPC and package leaflet to include a warning about the risk of reactivation of chronic hepatitis B (HBV) in patients receiving Humira (Trudexa) adalimumab to treat rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis or severe Crohn’s disease, from Abbott Laboratories (ABT).
— Ketek: CHMP revised EPAR and related scientific discussion (PDF file) about updates to the SPC and package leaflet limiting use of Ketek telithromycin in acute exacerbation of chronic bronchitis (AECB), acute sinusitis and tonsilitis/pharyngitis to patients with certain known or resistant bacterial strains. Ketek is from sanofi-aventis Group (Euronext:SAN; SNY).
Reyataz: CHMP revised EPAR updating the SPC and package leaflet to state that it is not possible to confirm a positive lipid profile relative to other antiretroviral agents for patients taking Reyataz atazanavir to treat HIV-1, from Bristol-Myers Squibb Co. (BMY).
Tysabri: Final NICE appraisal determination recommending use of Tysabri natalizumab in patients with evolving severe relapsing-remitting multiple sclerosis (MS), from Biogen Idec Inc. (BIIB) and Elan Corp. plc. (ELN).
Zonegran: CHMP revised EPAR updating the SPC, label and package leaflet to include stronger warnings on the potential to develop serious rashes, birth defects, and certain excessive emotional behavior in adults taking Zonegran zonisamide to treat seizures, from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).

NSAIDs (PDF file) (July 2, 2007)
EMEA Q&A on its recent review of peroxicam, and the agency's decision to recommend the non-selective anti-inflammatory drug (NSAID) no longer be used to treat acute pain and inflammation.

Orphan drugs (PDF file) (July 2, 2007)
Summary of actions taken at the June meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Pre- and post-authorization procedures (July 2, 2007)
Draft EMEA guidance regarding pre-submission meetings with the agency to discuss marketing authorization applications (MAAs) for human medicinal products. (PDF file)
Updated Q&A regarding EMEA guidance on post-authorization procedures for authorization holders.

Product documentation (July 2, 2007)
— Iplex: EMEA report (PDF file) and related Q&A on the withdrawal of an MAA for Iplex mecasermin rinfabate to treat growth failure in children with primary IGF-1 deficiency (IGFD), from Insmed Inc. (INSM).
Orgalutran: CHMP revised EPAR updating the SPC to include results from clinical trials showing the incidence of congenital malformations in children born from patients taking Orgalutran ganirelix is comparable with that reported after treatment with a gonadotropin-releasing hormone (GnRH) agonist. Orgalutran is from the Organon Biosciences unit of Akzo Nobel N.V. (Euronext:AKZ; AKZOY).
Revlimid: CHMP EPAR for Revlimid lenalidomide to treat second-line or later multiple myeloma (MM) in combination with dexamethasone, from Celgene Corp. (CEGE).
Soliris: CHMP EPAR for Soliris eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH), from Alexion Pharmaceuticals Inc. (ALXN).

CMS (June 25, 2007)
Centers for Medicare & Medicaid Services proposal that no National Coverage Decision (NCD) is currently needed for nebulized beta adrenergic agonist therapies for lung diseases (see BioCentury Extra, Wednesday, June 20).

Intra-agency cooperation (PDF files) (June 25, 2007)
— Updated confidentiality agreement between the European Commission and EMEA, and the FDA and HHS regarding the exchange of advance drafts of certain sensitive documents.
— FDA and EMEA document describing a framework for information exchange on scientific and ethical issues for pediatric therapeutics.

Pharmacogenetics (PDF file) (June 25, 2007)
FDA guidance covering the data and analyses needed to support approval of pharmacogenetic tests and genetic tests for heritable markers therapeutics (see BioCentury Extra, Tuesday, June 19).

Product documentation (June 25, 2007)
Avastin: CHMP revised EPAR updating the SPC with information on venous thromboembolic events and to consolidate safety information on label of Avastin bevacizumab to treat colorectal and breast cancer, from Roche (SWX:ROG) and Genentech Inc. (DNA).
Sustiva: CHMP revised EPAR updating the SPC by adding gynaecomastia to the list of adverse reactions to Sustiva efavirenz for HIV, from Bristol-Myers Squibb (BMY).
Truvada: CHMP revised EPAR updating the SPC and package leaflet to include a warning regarding the possible exacerbation of hepatitis when the treatment for HIV is discontinued.
Viracept: Q&A on actions that EMEA is recommending as a follow-up to the June 6 recall of HIV drug Viracept nelfinavir, from Roche (SWX:ROG), which was issued due to concerns of possibly toxic levels of ethyl mesilate (PDF file).

Allergy (PDF file) (June 18, 2007)
Draft CHMP guideline on the clinical development of products for specific immunotherapy to treat allergic diseases.

Anti-TNF agents (June 18, 2007)
Decision from appeal panel ordering the U.K.'s National Institute for Health and Clinical Excellence (NICE) to reconsider its ruling that rheumatoid arthritis patients who failed to respond to one anti-TNF agent should not be given treatment with a second anti-TNF agent (see BioCentury Extra, Tuesday, June 12).

Bioavailability/bioequivalence (PDF files) (June 18, 2007)
— EMEA recommendation on the need to update and clarify certain aspects of its note for guidance on the investigation of bioavailability and bioequivalence of systemic agents.
— EMEA concept paper on the possibility of waiving in vivo bioequivalence studies in favor of specific comparative in vitro testing for oral immediate-release products.

Gene/cell therapy (PDF file) (June 18, 2007)
CHMP concept paper on the development of a guideline on the characteristics, and preclinical and clinical aspects of medicinal products containing genetically modified cells.

Influenza vaccines (PDF file) (June 18, 2007)
Draft guidance document on EMEA's fast track procedure for the annual strain update for seasonal influenza vaccines.

Macular degeneration (June 18, 2007)
Appraisal consultation document from the U.K.'s National Institute for Health and Clinical Excellence (NICE) recommending the limited use of Lucentis ranibizumab from Genentech Inc. (DNA) and Novartis AG (NVS; SWX:NOVN); and against use of Macugen pegaptanib from OSI Pharmaceuticals Inc. (OSIP) and Pfizer Inc. (PFE) on the National Health Service to treat wet age-related macular degeneration (AMD) (see BioCentury Extra, Thursday, June 14).

Pharmacogenetics (PDF file) (June 18, 2007)
CHMP reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products.

Pharmacovigilance (PDF file) (June 18, 2007)
Draft EMEA reflection paper on proposed criteria for a 5-year renewal for centrally authorized medicinal products based on pharmacovigilance.

Product documentation (June 18, 2007)
— Actos: CHMP revised EPAR updating the SPC to include reference to potential risk of interaction with gemfibrozil and rifampicin and cases of macular edema reported in patients receiving Actos (Glustin) pioglitazone to treat Type II diabetes, from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
— Advate: CHMP revised EPAR updating the safety information on the SPC for Advate octocog alfa to prevent and control bleeding episodes associated with hemophilia A, from Baxter International Inc. (BAX).
— Architect Stat: Class 1 recall of Architect Stat Troponin-1 Immunoassay to diagnose damage to the heart and/or heart attack in people with chest pain, from Abbott Laboratories (ABT).
— Integrilin: CHMP revised EPAR updating the SPC, labeling and package leaflet to include a lower recommended standard infusion dose in patients with moderate renal impairment for Integrilin eptifibatide to treat acute coronary syndromes, from GlaxoSmithKline plc (LSE:GSK; GSK) and Millennium Pharmaceuticals Inc. (MLNM).
— Kogenate: CHMP revised EPAR updating the SPC and package leaflet to include continuous infusion as an additional mode of administration for Kogenate (Helixate NexGen) recombinant Factor VIII to treat hemophilia A, from Bayer AG (FSE:BAY; BAY).
— NovoSeven: CHMP revised EPAR updating the SPC and package leaflet to recommend an alternate dose of NovoSeven recombinant Factor VIIa to treat mild to moderate bleeding episodes in hemophilia patients with antibodies to Factors VIII or IX, from Novo Nordisk A/S (CSE:NVO; NVO).
— Truvada: CHMP revised EPAR for Truvada emtricitabine/tenofovir updating the SPC and package leaflet to include the risk of hepatitis reactivation after emtricitabine or tenofovir discontinuation, from Gilead Sciences Inc. (GILD).
— Velcade: Draft NICE guidance on National Health Service (NHS) use of Velcade bortezomib for patients with multiple myeloma (MM) who have received at least one prior therapy and who show a response to the drug, from Millennium Pharmaceuticals Inc. (MLNM) and Johnson & Johnson (JNJ).
— Zimulti: Briefing documents from the June 15 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss an NDA for Zimulti (Acomplia) rimonabant as an adjunct to diet and exercise for obese patients or overweight patients with associated risk factors, from sanofi-aventis Group (Euronext:SAN; SNY) (see Cover Story).

Antibodies (PDF file) (June 11, 2007)
Draft EMEA guidance on the manufacture and characterization of therapeutic and diagnostic monoclonal antibodies.

ESAs (June 11, 2007)
Comments from Amgen Inc. (AMGN) and others in response to proposed coverage restrictions on erythropoiesis stimulating agents from the Centers for Medicare and Medicaid Services (CMS) (see BioCentury Extra, Monday June 5).

SOX (June 11, 2007)
Link to testimony in last week’s House Small Business Committee hearing on Section 404 implementation of the Sarbanes-Oxley Act (see BioCentury, June 11):

Product documentation (June 11, 2007)
Abilify: CHMP revised EPAR updating the SPC and label to include warnings for patients with certain cardiac disorders or on certain other medications, as well as an updated list of post-marketing adverse events reported in patients taking Abilify aripiprazole to treat schizophrenia, from Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768).
Avandia: Portal for the New England Journal of Medicine containing the newly published interim data from the RECORD safety study of diabetes drug Avandia rosiglitazone, from GlaxoSmithKline plc (LSE:GSK; GSK), and accompanying editorials (see BioCentury, June 11).
Hepsera: CHMP revised EPAR updating the SPC and label to include pancreatitis as an adverse reaction for Hepsera adefovir to treat chronic hepatitis B (HBV) in adults, from Gilead Sciences Inc. (GILD).
Viramune: CHMP revised EPAR updating the SPC to include reports of rhabdomyolysis in patients experiencing skin and/or liver reactions when taking Viramune nevirapine to treat HIV-1 infection, from Boehringer Ingelheim GmbH.
Viread: CHMP revised EPAR updating the SPC to include the risk that hepatitis infection could be exacerbated when the treatment is discontinued in patients taking Viread tenofovir to treat HIV infection, from Gilead Sciences Inc. (GILD).
— Vitragan: EMEA statement and a new Q&A on the withdrawal of an MAA following the agency’s request for additional information on Vitragan (Vitrase) ovine hyaluronidase to treat vitreous hemorrhage in adults, from Ista Pharmaceuticals Inc. (ISTA). (PDF files)

Asthma (June 4, 2007)
NICE appraisal consultation document on inhaled corticosteroids to treat chronic asthma in children under 12 years of age.

Bioequivalence (PDF file) (June 4, 2007)
Draft FDA guidance outlining the agency's intention to issue product-specific guidances on the bioequivalence studies necessary for ANDA submissions.

Influenza (PDF files) (June 4, 2007)
— EMEA proposed changes to guidance on the structure of a marketing application for a pandemic influenza virus
— FDA guidance on regulatory approval of seasonal flu vaccines.

Orphan drugs (PDF file) (June 4, 2007)
Summary of actions taken at the May meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Product documentation (June 4, 2007)
— Champix: NICE recommendation for the use of Champix varenicline to assist in smoking cessation, from Pfizer Inc. (PFE).
— Xigris: CHMP revised EPAR updating the SPC with information on increased risk of serious bleeding events in surgical patients receiving Xigris drotrecogin alfa to treat sepsis and multiple organ failure, from Eli Lilly and Co. (LLY).

Avandia (PDF files) (May 28, 2007)
— EMEA statement regarding its review of safety data and label changes to Avandia rosiglitazone in the EU and U.S., released in response to a study in the New England Journal of Medicine linking Avandia to myocardial infarction.
— Congressional correspondence to FDA regarding Avandia, including an April 30 request for an agency decision on the safety of the drug and a May 4 request for a briefing from FDA staff.

Gene therapy (PDF files) (May 28, 2007)
Draft EMEA guideline on preclinical studies required prior to human trials of gene therapy products, and a concept paper on the development of a guideline on clinical monitoring and follow-up of patients treated with gene therapy products.

Pandemic influenza (PDF file) (May 28, 2007)
EMEA standard operating procedures for the evaluation of urgent Type II variation applications for antivirals to treat pandemic influenza.

Product documentation (May 28, 2007)
— Exjade: "Dear Healthcare Provider" letter summarizing changes made to the warnings and adverse reactions sections, including cases of acute renal failure, for Exjade deferasirox to treat chronic iron overload due to blood transfusions, from Novartis AG (NVS; SWX:NOVN). (PDF file)
— Orlistat GSK: CHMP positive opinion on an MAA for Orlistat GSK to treat obesity and associated risk factors when used in conjunction with a mildly hypocaloric diet, from GlaxoSmithKline plc (LSE:GSK; GSK). (PDF file)
— Plavix: CHMP positive opinion (PDF file) for the expanded label of Plavix (Iscover) clopidogrel to include patients undergoing a stent placement following percutaneous coronary intervention, from Bristol-Meyers Squibb Co. (BMY) and sanofi-aventis Group (Euronext:SAN; SNY), and a CHMP revised EPAR updating the package leaflet and the summary of product information to reflect a potential interaction of COX-2 inhibitors with Plavix.

Embryo research (May 21, 2007)
U.K. Department of Health proposed draft revisions to legislation on assisted reproduction and embryology, including the establishment of the Regulatory Authority for Tissue and Embryos (RATE) (see BioCentury Extra, Thursday May 17).

ESAs (May 21, 2007)
CMS proposed National Coverage Decision (NCD) to limit coverage of erythropoiesis stimulating agents for patients with certain cancers and related neoplastic conditions (see BioCentury, May 21).

Flu vaccine (PDF file) (May 21, 2007)
EMEA recommendations on pharmacovigilance as part of a Risk Management Plan in marketing applications for pandemic influenza vaccines.

HCV (PDF file) (May 21, 2007)
EMEA concept paper on developing medicinal products for the treatment of hepatitis C (HCV) infection.

Labeling (PDF file) (May 21, 2007)
Draft FDA guidance for determining the established pharmacologic class of a drug for inclusion in the prescribing information of approved labeling.

Trial registries (PDF file) (May 21, 2007)
Handbook from U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Service (CMS) to serve as a guide for creating and maintaining clinical trial registries.

Product documentation (May 21, 2007)
ACAM2000: Briefing documents from the May 17 meeting of FDA's Vaccines and Related Biological Products Advisory Committee meeting to discuss a BLA for ACAM2000 smallpox vaccine from Acambis plc (LSE:ACM; ACAM) (see BioCentury, May 21).
Actilyse: NICE recommendation for the use of Actilyse alteplase to treat acute ischemic stroke, from Boehringer Ingelheim GmbH and Genentech Inc. (DNA) (PDF file)
Advagraf: CHMP EPAR for Advagraf tacrolimus to prevent transplant rejection in adult kidney or liver allograft recipients and to treat allograft rejection resistant to treatment with other immunosuppressive agents, from Astellas Pharma Inc. (Tokyo: 4503).
Crixivan: CHMP revised EPAR updating the contraindications section to include amiodarone as a medicine that must not be co-administered with Crixivan indinavir to treat HIV-1, from Merck & Co. Inc. (MRK).
Docetaxel: CHMP EPAR for Docetaxel Winthrop to treat breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer, from sanofi-aventis Group (Euronext:SAN; SNY).
Erbitux: NICE final appraisal document recommending against the use of Erbitux cetuximab in combination with radiotherapy to treat locally advanced squamous cell carcinoma of the head and neck (SCCHN), from ImClone Systems Inc. (IMCL), Bristol-Myers Squibb Co. (BMY), and Merck KGaA (FSE:MRK) (see BioCentury Extra, Wednesday May 16). (PDF file)
FluMist: Briefing documents from the May 16 meeting of the Vaccines and Related Biological Products Advisory Committee to review CAIV-T intranasal influenza vaccine, a refrigerator-stable formulation of FluMist from MedImmune Inc. (MEDI) (see BioCentury, May 21).
Humira: CHMP revised EPAR updating the package leaflet to include a warning of the risk of reactivation of chronic hepatitis B in patients receiving Humira adalimumab to treat Crohn’s disease, rheumatoid arthritis (RA), psoriatic arthritis or ankylosing spondylitis, from Abbott Laboratories (ABT).
Remicade: CHMP revised EPAR updating the summary of product characteristics to include information of the increase of hemoglobin levels from baseline in patients with rheumatoid arthritis and anemia associated with Remicade infliximab to treat psoriasis, Crohn’s disease, RA and psoriatic arthritis in the EU, from Johnson & Johnson (JNJ) and Schering-Plough Corp. (SGP).
Toviaz: CHMP EPAR for Toviaz fesoterodine to treat overactive bladder (OAB), from Schwartz Pharma AG (FSE:SRZ)
Truvada: CHMP revised EPAR updating the summary product characteristics and package leaflet to add a warning of possible exacerbation of hepatitis with the discontinuation of treatment with Truvada emtricitabine/tenofovir to treat HIV infection, from Gilead Sciences Inc. (GILD).

ESAs (May 14, 2007)
Briefing materials from the May 10 meeting of FDA's Oncologic Drugs Advisory Committee discussion on potential restrictions on the use of approved erythropoiesis-stimulating agents (ESAs) (see Cover Story).

Gene profiling (PDF files) (May 14, 2007)
FDA guidance on premarket notifications and labeling requirements for breast cancer expression profiling systems, formed in response to a granted petition by Agendia B.V. to reclassify its MammaPrint test as a class II, or special controls, device.

Product documentation (May 14, 2007)
— Activase: NICE recommendation in favor of Activase alteplase to treat acute ischemic stroke, from Genentech Inc. (DNA) and Boehringer Ingelheim GmbH
— Arcoxia: Slide presentations from the April 12 meeting of FDA's Arthritis Advisory Committee review of Arcoxia etoricoxib to treat osteoarthritis (OA), from Merck & Co. Inc. (MRK) (see BioCentury, April 16).
— Focetria: CHMP EPAR for Focetria pandemic influenza vaccine from Novartis AG (NVS; SWX:NOVN).
— Junovan: Briefing materials for the May 9 meeting of FDA's Oncologic Drugs Advisory Committee to review Junovan mifamurtide to treat newly diagnosed high-grade osteosarcoma, from IDM Pharma Inc. (IDMI) (see "A Roll of the Dice").
— orBec: Briefing materials for the May 9 meeting of FDA's Oncologic Drugs Advisory Committee to review orBec beclomethasone dipropionate to treat gastrointestinal graft-versus-host disease (GvHD), from Dor BioPharma Inc. (DORB).
— Sebivo: CHMP EPAR for Sebivo telbivudine to treat chronic hepatitis B (HBV) in adults with compensated liver disease and evidence of viral replication, from Idenix Pharmaceuticals Inc. (IDIX) and Novartis AG (NVS; SWX:NOVN).
— Tamiflu: CHMP revised EPAR updating the SPC and package leaflet to include neuropsychiatric disorders, cough and vertigo in patients taking Tamiflu oseltamivir to treat influenza in adults and children, from Roche (SWX:ROG).

Antidepressants (May 7, 2007)
FDA website regarding its request to update the black box warnings on antidepressants to describe an association of short term use with suicidality in adults ages 18-24 (see BioCentury Extra, Wednesday May 2).

Bioequivalence (May 7, 2007)
Report from FDA's Office of Generic Drugs outlining the development impediments for certain types of generic drugs that lack class-specific bioequivalence protocols.

Follow-on biologics (May 7, 2007)
— A concept paper from the Biotechnology Industry Organization (BIO) on the legal and regulatory issues associated with FOBs (see "Biodissimilar"). (PDF file)

Public relations (May 7, 2007)
Website for the Grant Office of Eli Lilly and Co. (LLY), providing guidelines and policies for the company's funding of healthcare educational programs.

Product documentation (May 7, 2007)
— Celsentri: Briefing materials from the April 24 meeting of FDA's Antiviral Drugs Advisory Committee review of Celsentri maraviroc for treatment-experienced patients with CC chemokine receptor 5 (CCR5)-tropic HIV-1 infection, from Pfizer Inc. (PFE). (see BioCentury, April 30).
— OrBec: Notice of a May 9 meeting of FDA's Oncology Drug Advisory Committee to discuss an NDA for OrBec beclomethasone dipropionate to treat gastrointestinal graft-versus-host disease (GvHD), from Dor BioPharma Inc. (DORB). (PDF file)
— Junovan: Notice of a May 9 meeting of FDA's Oncology Drug Advisory Committee to discuss an NDA for Junovan mifamurtide to treat newly diagnosed high-grade osteosarcoma following surgical resection, from IDM Pharma Inc. (IDMI). (PDF file)

Drug development (PDF file) (April 30, 2007)
Final report from an EMEA/CHMP think tank on innovative drug development aimed at identifying scientific bottlenecks to the development of new medicines in both academia and industry.

HIV (PDF file) (April 30, 2007)
Draft report from a joint meeting of FDA and Forum for Collaborative HIV Research (FCHR) to discuss approaches to HIV drug development through planning for long-term monitoring of CCR5 antagonist safety (see BioCentury, April 30).

Drug safety (April 30, 2007)
FDA website providing access to audio podcasts about emerging drug safety information.

Limbal stem cell transplant (April 30, 2007)
An informational leaflet on when and how cultivated stem cell transplant can be used to treat limbal stem cell deficiency.

Orphan drugs (PDF files) (April 30, 2007)
EMEA checklist of required documents for applying for the transfer of Orphan Medicinal Product (OMP) designation, and rules of procedure for EMEA’s Committee for Orphan Medicinal Products.

Product documentation (PDF files) (April 30, 2007)
Advair Diskus: Notice of a May 1 meeting of FDA's Pulmonary and Allergy Drugs Advisory Committee to discuss an NDA from GlaxoSmithKline plc (LSE:GSK; GSK) for Advair Diskus salmeterol/fluticasone propionate to reduce exacerbations and increase survival in patients with chronic obstructive pulmonary disease (COPD).
Avastin: “Dear Healthcare Provider” letter from Genentech Inc. (DNA) warning about the risk of tracheoesophageal (TE) fistula formation associated with the use of Avastin bevacizumab in patients with small-cell lung cancer (SCLC) in clinical trials.
Junovan: Notice of the May 9-10 meeting of FDA’s Oncology Drugs Advisory Committee to discuss an NDA from IDM Pharma Inc. (IDMI) for Junovan mifamurtide to treat newly diagnosed high-grade osteosarcoma.

Anesthetics (April 23, 2007)
Presentations from the March 29 meeting of FDA's Anesthetic and Life Support Drugs Advisory Committee to discuss neurodegenerative findings in juvenile animals exposed to anesthetic drugs and their relevance to pediatric patients.

Cancer (PDF file) (April 23, 2007)
Supplementary information to the review of kinase targets in cancer published in Nature (see Cover Story).

NICE (April 23, 2007)
NICE 2007 guide to its process for formulating technology appraisals (see BioCentury Extra, Monday, Apr. 16).

Product documentation (April 23, 2007)
— Celsentri: Briefing documents for the April 24 meeting of FDA's Antiviral Drugs Advisory Committee to discuss an NDA for Celsentri maraviroc to treat antiretroviral-experienced patients with CCR5-tropic HIV, from Pfizer Inc. (PFE) (see BioCentury Extra, Friday April 20).
— Norvasc: FDA letter (PDF file) and list of comments solicited by FDA on issues related to ANDA submissions for generic versions of Norvasc amlodipine to treat hypertension, from Pfizer Inc. (PFE).

FDA performance (PDF files) (April 16, 2007)
Percentage of marketing approvals granted by FDA's CDER within 36 months after receiving an NDA/BLA, including applications granted standard and priority review between 1998 and 2005.

CMS (April 16, 2007)
Proposed revisions from the Centers for Medicare & Medicaid Services to its Medicare National Clinical Trial Policy (see BioCentury Extra, Tuesday, April 10).

Drug safety (PDF file) (April 16, 2007)
Draft FDA guidance on adverse event reporting and improving human subject protection.

E. coli infection (PDF file) (April 16, 2007)
Briefing documents from the April 12 joint meeting of the Pediatric Advisory Committee and Anti-Infective Drug Advisory Committee to discuss development pathways and clinical trial designs for products seeking approval for prevention of sequelae of Shiga Toxin-producing E. coli infection.

Product documentation (April 16, 2007)
— Arcoxia: Briefing documents from the April 12 meeting of FDA's Arthritis Advisory Committee to review an NDA for Arcoxia etoricoxib for the relief of the signs and symptoms of osteoarthritis, from Merck & Co. Inc. (MRK) (see Cover Story).
— Zanaflex: "Dear Healthcare Professional" letter reporting the contraindication of CYP1A2 inhibitors such as ciprofloxacin or fluvoxamine with Zanaflex tizanidine to treat spasticity, from Acorda Therapeutics Inc. (ACOR). (PDF file)

Drug Safety (April 9, 2007)
The Safer Drug Assessment Technology Advancement Act (S. 1024), which would require FDA to collaborate with the private sector to create an active post-marketing safety surveillance system (see BioCentury Extra, Thursday March 22). (PDF file)

HSV (PDF files) (April 9, 2007)
FDA guidance outlining new requirements for serological assays for herpes simplex virus 1 and 2 resulting from their reclassification from class III to class II devices, and notice stating that the change will take effect May 3, 2007.

Post-marketing studies (April 9, 2007)
New FDA portal for tracking the progress of certain post-approval studies involving medical device.

Stem cells (PDF file) (April 9, 2007)
Report by U.K.'s House of Commons Science and Technology Committee supporting the creation of hybrid human/non-human embryos for stem cell research (see BioCentury Extra, Thursday, April 5).

Product documentation (April 9, 2007)
Alimta: NICE recommendation against the use of Alimta pemetrexed disodium to treat malignant pleural mesothelioma, from Eli Lilly and Co. (LLY).
MabThera (Rituxan): NICE recommendation against the use of MabThera rituximab to treat adults with severe active rheumatoid arthritis, from Roche (SWX:ROG) (marketed as Rituxan in U.S. by Biogen Idec xxx (BIIB) and Genentech Inc. (DNA).
Tysabri: NICE recommendation against the use of Tysabri natalizumab to treat adults with highly active relapsing–remitting multiple sclerosis (MS), from Biogen Idec Inc. (BIIB) and Elan Corp. plc (ELN).

First-in-man trials (PDF file) (April 2, 2007)
CHMP draft guideline for first-in-man clinical trials of potentially high-risk medicinal products.

Follow-on biologics (April 2, 2007)
— BIO's principles for creating a regulatory pathway for approving FOBs, released in response to the Access to Life-Saving Medicine Act (H.R. 1038/S. 623)(see BioCentury, March 12).

GM crops (PDF file) (April 2, 2007)
USDA's Animal and Plant Health Inspection Service policy for responding to low-levels of regulated genetically engineered plant materials in commercial seeds or grain.

Product documentation (April 2, 2007)
— Provenge: Briefing documents from the March 29 meeting of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee to review Provenge sipuleucel-T, an autologous dendritic cell therapy, to treat asymptomatic patients with metastatic, androgen-independent prostate cancer from Dendreon Corp. (DNDN) (see "Provenge: Substanial Enough," A17).
— Velcade: Decision from the NICE appeal panel, partially upholding an appeal against a NICE decision not to recommend use of Velcade bortezomib for multiple myeloma (MM), from Millennium Pharmaceuticals Inc. (MLNM) and Johnson & Johnson (JNJ).

Conflict of Interest (March 26, 2007)
— Draft FDA guidance on revised procedures for determining conflict of interest and eligibility to participate in advisory committees, as well as a related press release (see "The Price of Pristine").
— FDA's "Nature and Basis" statements of COI for the March 29 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee to review Provenge, from Dendreon Corp. (DNDN, Seattle, Wash.)
— Public Citizen study on "Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings" and the agency's comment on the study.

Drug safety (PDF file) (March 26, 2007)
Congressional testimony by Marcia Crosse, director of healthcare for the U.S. Government Accountability Office (GAO), citing a need for FDA to further address shortcomings in its post-market decision-making process.

PDUFA (March 26, 2007)
Public comments regarding the proposed PDUFA IV law received by FDA during the 30-day comment period ending Feb. 23 (see BioCentury Extra, Friday March 23).

Pediatric drugs (PDF file) (March 26, 2007)
U.S. Government Accountability Office (GAO) report describing the extent of post-marketing pediatric studies conducted under the Best Pharmaceuticals for Children Act (BPCA).

Vaccines (PDF file) (March 26, 2007)
The Vaccines for the Future Act of 2007 (H.R. 1391, S.569), which seeks to speed the development, testing and distribution of vaccines for developing countries through increased U.S. participation in international efforts and innovative financial incentives (see BioCentury Extra, Friday, March 23).

Product documentation (March 26, 2007)
— Lovenox: Public comments received by FDA regarding a 2003 Citizen's Petition lodged by sanofi-aventis Group (Euronext:SAN; SNY) asserting that Lovenox heparin is too poorly characterized to permit a generic form unless an ANDA applicant demonstrates that it has used a manufacturing process equivalent to SAN's or provided clinical data that is not permitted in the application.
— Rotateq: Analysis posted by CDC's morbidity and mortality weekly report (MMWR) suggesting that reported cases of intussusception are not above the expected background rate in infants who received RotaTeq rotavirus vaccine from Merck & Co. Inc. (MRK).

EPO drugs (March 12, 2007)
FDA alert and documentation on label changes for erythropoiesis stimulating agents Procrit from Johnson & Johnson (JNJ) and Epogen and Aranesp from Amgen Inc. (AMGN) (see BioCentury, March 12).

Pediatric drugs (PDF files) (March 12, 2007)
FDA guidance on clinical trials designed to evaluate the effects of oral, Inhaled, and intranasal corticosteroids on growth in children.

User fees (March 12, 2007)
FDA-related to legislation that could be attached to the PDUFA reauthorization, as well as existing FDA-related laws up for renewal (see BioCentury, March 12).
HHS PDUFA IV proposal. (PDF file)
Pediatric Research Equity Act of 2003
Pharmaceutical Market Access and Drug Safety Act of 2007 (S.242). (PDF file)
Fair Prescription Drug Competition Act (S 438) [generic exclusivity] (PDF file)
“Enhancing Drug Safety and Innovation Act of 2007'' (S 484).
Safe Internet Pharmacy Act of 2007 (S 596). (PDF file)
Access to Life-Saving Medicine Act (S 623) [follow-on biologics]
Tanning Accountability and Notification Act of 2007 (S 668) (PDF file)
Genomics and Personalized Medicine Act of 2006 (S.3822) [version from the 109th Congress) (PDF file)
Pediatric Medical Device Safety and Improvement Act
RU-486 Suspension and Review Act of 2007 (HR 63). (PDF file)

Product documentation (March 12, 2007)
Actos: "Dear Healthcare Provider" letter from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) reporting that significantly more female patients receiving Actos pioglitazone to treat Type II diabetes experienced distal fractures of the arm and leg than did female patients who received comparator drugs. (PDF file)
— Tarceva: NICE final technology appraisal determination and related comments regarding the institute's recommendation against Tarceva erlotinib to treat locally advanced or metastatic non-small-cell lung cancer, from Roche (SWX:ROG). OSI Pharmaceuticals Inc. (OSIP) and Genentech Inc. (DNA) have U.S. rights (see BioCentury Extra, Friday March 9).

Advisory committees (PDF file) (March 5, 2007)
Draft FDA guidance detailing the process of developing, preparing, submitting and disclosing briefing materials that will be given to committee members prior to public meetings (see "Advisory Committee Timetable").

Sarbanes-Oxley (March 5, 2007)
Comments to SEC regarding its proposed reforms of reporting requirements under Section 404 of SOX (see Ebb & Flow).

Product documentation (March 5, 2007)
— Baraclude: "Dear Healthcare Provider" letter from Bristol-Meyers Squibb Co. (BMY), warning of a report of a resistant HIV variant in a co-infected patient who was receiving Baraclude entecavir for chronic HBV, but not simultaneous antiretroviral HIV therapy. (PDF file)
— H5N1 Vaccine: Briefing documents for the Feb. 27-28 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to review a BLA for H5N1 influenza virus vaccine from sanofi-aventis Group (Euronext:SAN; SNY). (PDF file)

Drug pricing (PDF files) (February 26, 2007)
— “Medicare Enhancements for Needed Drugs Act of 2007” (S. 250) which would give HHS power to negotiate drug prices for Medicare Part D (see BioCentury, Feb. 26). (PDF file)

Product documentation (February 26, 2007)
Avandia: "Dear Healthcare Provider" letter from GlaxoSmithKline plc (LSE:GSK; GSK) reporting that significantly more female patients receiving Avandia rosiglitazone to treat Type II diabetes experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. (PDF file)

Obesity (PDF file) (February 19, 2007)
Draft FDA guidance for the development of therapeutics for medical weight loss.

Product documentation (February 19, 2007)
— Alimta: NICE final appraisal determination recommending against Alimta pemetrexed to treat locally advanced or metastatic non-small cell lung cancer (NSCLC), from Eli Lilly and Co. (LLY).

HIV (PDF file) (February 12, 2007)
FDA guidance describing circumstances under which PDUFA fees can be waived on applications for combination and co-packaged versions of previously approved antiretroviral therapies to treat HIV.

In vitro diagnostics (February 12, 2007)
— FDA's draft guidance (PDF file) on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), and public comments (see Cover Story).
Website for The Coalition for 21st Century Medicine.

Pediatrics (PDF files) (February 5, 2007)
Draft EC guidance on the format and content of applications for conducting clinical trials involving pediatric patients.

Product documentation (February 5, 2007)
Aranesp: Amgen Inc. (AMGN) issues issued “Dear Healthcare Provider” letter reporting that Aranesp darbepoetin alfa was ineffective in reducing red blood cell transfusions or fatigue in a Phase III trial of cancer patients with anemia that is not due to concurrent chemotherapy (see BioCentury Extra, Friday, Jan. 26).
Herceptin: Genentech Inc. (DNA) and Roche (SWX:ROG) add a boxed warning to the label of breast cancer drug Herceptin trastuzumab label to include an increased incidence and severity of left ventricular cardiac dysfunction/congestive heart failure (CHF) in patients who received Herceptin with anthracycline-containing chemotherapy regimens, and of serious infusion reactions and pulmonary toxicity. (PDF file)
Humira: Abbott Laboratories (ABT) modifies the label of Humira adalimumab to warm of an increased rate of malignancies, other than lymphoma and non-melanoma skin cancer, that were observed in clinical trials in patients receiving anti-TNF agents to treat rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. (PDF file)
Mirapex: Pfizer Inc. (PFE) and Boehringer Ingelheim GmbH modify the label of Mirapex (Mirapexin, Sifrol) pramipexole to treat Parkinson’s disease (PD) and restless legs syndrome (RLS) to include a warning that one patient reported hallucinations. (PDF file)

Follow-on biologics (PDF file) (January 29, 2007)
The Access to Life-Saving Medicine Act (H.R. 6257), introduced in the 109th Congress, which sought to establish a process for the approval of a comparable biological product based on its similarity to a previously licensed biological product (see BioCentury Oct. 2, 2006).

Generics (PDF file) (January 29, 2007)
The proposed Preserve Access to Affordable Generics Act (S.316), which would ban patent infringement settlements in which a generic company receives anything of value or agrees not to research, develop, manufacture, market, or sell the generic for any period of time (see BioCentury Extra, Friday, Jan. 19).

Genetic testing (January 29, 2007)
Draft FDA guidance and public comments regarding premarket approval of certain genetic tests that use clinical data derived from in vitro assays and an algorithm to diagnose or guide the treatment of a disease (see BioCentury Extra, Thursday, Jan. 25).

Product documentation (January 29, 2007)
— Gemzar: NICE technology appraisal recommending use of Gemzar gemcitabine, from Eli Lilly and Co. (LLY), for the treatment of metastatic breast cancer only in situations where docetaxel monotherapy or docetaxel plus capecitabine are also appropriate.
— Pentacel: Briefing documents for the Jan. 25 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss the safety and immunogenicity of Pentacel, a combination of five vaccines for diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type B from sanofi-aventis Group (Euronext:SAN; SNY).

Antipsychotics (PDF file) (January 22, 2007)
Report by the HHS Agency for Healthcare Research and Quality identifying the major off-label uses of atypical antipsychotics and summarizing evidence on efficacy in such indications.

Contraceptives (January 22, 2007)
Notice and briefing (PDF file) documents for the Jan. 23-24 meeting of FDA's Advisory Committee for Reproductive Health Drugs to discuss clinical trial design, risk/benefit assessment and acceptability measures for oral and non-oral contraceptives.

Genetic discrimination (PDF file) (January 22, 2007)
The Genetic Information Nondiscrimination Act of 2007 (H.R. 493), which seeks to prohibit discrimination in health insurance and employment on the basis of genetic information (see BioCentury Extra, Thursday, Jan. 18).

TRIPS (January 22, 2007)
Report from Indian government-appointed expert group concluding that provisions of the country's patent law violate India's obligations under the WTO Agreement on Trade Related Aspects of IP Rights (TRIPS) (see BioCentury Extra, Thursday, Jan. 18).

Product documentation (January 22, 2007)
— Pentacel: Notice of the Jan. 25 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss the safety and immunogenicity of Pentacel, a combination of five vaccines for diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type B from sanofi-aventis Group (Euronext:SAN; SNY).
— Ventavis: Anxiety (January 15, 2007) NICE draft guidance for consultation on the management of anxiety in adults.

Depression (January 15, 2007)
NICE draft guidance for consultation on the management of depression.

Diagnostics (PDF file) (January 15, 2007)
Announcement of Feb. 8 public meeting to discuss FDA’s draft guidance on in vitro diagnostic multivariate index assays (IVDMIAs) (see BioCentury Extra, Tuesday, Jan. 9).

Drug misuse (January 15, 2007)
NICE draft guidance for consultation on the psychosocial management of drug misuse.

Drug prices (PDF file) (January 15, 2007)
Government Accountability Office (GAO) report reviewing approaches to negotiating prescription drug prices used by other countries, the U.S. private payers and federal programs.

Healthcare coverage (PDF file) (January 15, 2007)
Proposal by Gov. Arnold Schwarzenegger to require universal healthcare coverage in California (see BioCentury Extra, Tuesday Jan. 9).

Importation (PDF file) (January 15, 2007)
The proposed Pharmaceutical Market Access and Drug Safety Act, which would allow wide-scale importation of pharmaceuticals into the U.S. (see BioCentury Extra, Wednesday, Jan. 10).

Patents (PDF file) (January 15, 2007)
The U.S. Supreme Court ruling in MedImmune Inc. v. Genentech Inc. (DNA) (see BioCentury, Jan. 15).

PDUFA (PDF file) (January 15, 2007)
Proposed PDUFA IV recommendations from FDA to Congress (see BioCentury, Jan. 15).

Pharmacogenomics (PDF file) (January 15, 2007)
Draft FDA guidance establishing definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories.

Advisory committees (PDF file) (January 8, 2007)
Compendium of FDA advisory committee reports reviewing activities during the 2006 fiscal year (Oct.1, 2005, through Sept 30, 2006).

Animal cloning (January 1, 2007)
FDA draft risk assessment regarding milk and meat from cattle, pigs and goats produced through somatic cell nuclear transfer and their progeny (see BioCentury Extra, Thursday Dec. 28, 2006).

Ankylosing spondylitis (January 1, 2007)
NICE appraisal consultation document recommending conditions for use of Humira adalimumab from Abbott Laboratories (ABT), Enbrel etanercept from Amgen Inc. (AMGN) and Wyeth (WYE), and Remicade infliximab from Johnson & Johnson (JNJ) and Schering-Plough Corp. (SGP) for adults with severe active ankylosing spondylitis.

Glioblastoma multiforme (January 1, 2007)
NICE appraisal consultation document recommending Temodal temozolomide (Temodar-US) from Schering-Plough Corp. (SGP) to treat newly diagnosed glioblastoma multiforme (GBM), and against Gliadel carmustine implants from MGI Pharma Inc. (MOGN) and Link Pharmaceuticals Ltd. (West Sussex, U.K.) to treat newly diagnosed high-grade glioma.

R&D (PDF file) (January 1, 2007)
U.S. Government Accountability Office (GAO) report that a higher rate of drug industry R&D spending has not seen a corresponding increase in the number of NDA submissions and FDA approvals (see BioCentury Extra, Tuesday Dec.19, 2006).

OTC pain drugs (January 1, 2007)
FDA proposal to amend labeling on OTC analgesic, antipyretic, and antirheumatic drugs to include information regarding the potential for stomach bleeding and liver damage.

Pfizer (January 1, 2007)
New Pfizer Inc. (PFE) website tracking compounds in its pipeline.

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