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

Advertising (PDF file) (December 18, 2006)
Government Accountability Office (GAO) report calling for improvements in FDA's oversight of direct-to-consumer (DTC) advertising (see BioCentury Extra, Thursday, Dec. 14).

Expanded access (PDF files) (December 18, 2006)
FDA proposed rules designed to widen access to investigational drugs, and to clarify when charging for investigational treatments is appropriate (see BioCentury Extra, Monday, Dec. 11).

Sarbanes-Oxley (December 18, 2006)
SEC statement regarding proposed interpretive guidance for management to improve Section 404 Implementation (see BioCentury, Dec. 18).
— Final SEC rule (PDF file) extending the date by which smaller public companies must comply with Section 404, and an SEC summary of the rule.

Product documentation (December 18, 2006)
— Daronrix: A statement regarding the mock-up pandemic influenza vaccine Daronrix, an H5N1 whole virus inactivated antigen from GlaxoSmithKline plc (LSE:GSK; GSK). (PDF files)
Hemopure: Briefing documents for the Dec. 14 meeting of FDA’s Blood Products Advisory Committee to discuss the U.S. Navy's proposed Phase IIb/III RESUS trial of Hemopure (HBOC-201) from Biopure Corp. (BPUR) (see BioCentury, Dec. 18).
Ketek: Briefing documents for the Dec. 14-15 joint meeting of FDA’s Anti-Infective Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee to examine the overall benefit/risk profile of Ketek telithromycin from sanofi-aventis Group (Euronext:SAN; SNY) (see BioCentury, Dec. 18).
Tarceva: CHMP Q&A on its revised opinion to expand use of Tarceva erlotinib to include treatment of patients with metastatic cancer and in combination with gemcitabine, from Roche (ROG), Genentech Inc. (DNA) and OSI Pharmaceuticals Inc. (OSIP). (PDF file)

Antidepressants (PDF file) (December 11, 2006)
Briefing documents for the Dec. 13 meeting of FDA's Psychopharmacologic Drugs Advisory Committee to discuss the agency's meta-analysis of the effect of antidepressants on suicidal thoughts or behavior (see BioCentury Extra, Tuesday Dec. 5).

EMEA (December 11, 2006)
New EMEA public database designed to facilitate access to information about medicines available in the EU.

Reimbursement (PDF file) (December 11, 2006)
Government Accountability Office (GAO) report on Medicare payment policy covering drugs and services for patients with end stage renal disease (ESRD) (see BioCentury Extra, Wednesday Dec. 6).

Pediatrics (PDF file) (December 11, 2006)
Briefing document for the Dec. 6 meeting of FDA's Oncologic Drugs Advisory Committee to discuss endpoints for trials of treatments for pediatric brain tumors.

Stem cells (PDF files) (December 11, 2006)
A draft Scientific Strategic Plan identifying California Institute for Regenerative Medicine's priorities for stem cell research over the next 10 years (see BioCentury Extra, Friday Dec. 8).

Product documentation (December 11, 2006)
— Gemzar: NICE final appraisal determination recommending Gemzar gemcitabine from Eli Lilly and Co. (LLY) in combination with paclitaxel to treat metastatic breast cancer only when Taxotere docetaxel from sanofi-aventis (Euronext:SAN; SNY) as a monotherapy or in combination with Xeloda capecitabine from Roche (SWX:ROG) are also considered appropriate. (PDF file)
— Heparin: Label revision to include the possibility of delayed onset of heparin-induced thrombocytopenia (HIT), from Baxter International Inc. (BAX).

Australia (December 4, 2006)
New government website providing information about the regulation and development of biotechnology and related products in Australia.

Labeling (PDF files) (December 4, 2006)
FDA draft labeling guidance and comments from the Biotechnology Industry Organization (BIO) that the proposal could confuse rather than assist practitioners and the public.

Rheumatoid arthritis (PDF files) (December 4, 2006)
NICE final appraisal document recommending limited use of TNF alpha inhibitors to treat Alzheimer's disease symptoms, including 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), and a list of comments and responses on the appraisal. (see BioCentury Extra, Nov. 28).

Capital markets (December 4, 2006)
Interim summary from the Committee on Capital Markets Regulation, which concludes that U.S. capital markets are losing their competitiveness in global markets due in large part to regulatory and legal costs.

Product documentation (December 4, 2006)
— Celebrex: Briefing documents for the Nov. 29 meeting of FDA's Arthritis Advisory Committee to discuss use of Celebrex celecoxib to treat juvenile rheumatoid arthritis, from Pfizer Inc. (PFE). (PDF file)

eSubmissions (PDF file) (November 20, 2006)
FDA notice of a Dec. 18 public hearing to discuss the electronic submission of product information to the agency.

Pediatrics (November 20, 2006)
Briefing documents for the Nov. 16 meeting of FDA's Pediatric Advisory Committee to discuss adverse events for drugs granted pediatric exclusivity (see BioCentury Extra, Monday Nov. 13).

Rheumatoid arthritis (November 20, 2006)
NICE draft for the scope of a consultation document for the management and treatment of rheumatoid arthritis in adults.

Product documentation (November 20, 2006)
Alimta: NICE preliminary appraisal recommending against Alimta pemetrexed to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) from Eli Lilly and Co. (LLY) (see BioCentury Extra, Tuesday Nov. 14).
— Ketek: FDA notice of Dec. 14 -15 meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the benefit versus risk of Ketek telithromycin.
Tamiflu: “Dear Healthcare Professional" letter from Roche (SWX:ROCZ) for and revised precautions section of the label to include postmarketing reports of self-injury and delirium in patients treated with influenza drug Tamiflu oseltamivir (see BioCentury, Nov. 20). (PDF file)
Tarceva: NICE preliminary appraisal recommending against Tarceva erlotinib from OSI Pharmaceuticals Inc. (OSIP), Genentech Inc. (DNA) and Roche (SWX:ROCZ) for the second-line treatment of patients with locally advanced or metastatic NSCLC who would normally receive docetaxel (see BioCentury Extra, Tuesday Nov. 14).

Biosimilars (PDF file) (November 13, 2006)
Position paper from the Biotechnology Industry Organization (BIO) on naming and labeling requirements for biologics, including biosimilars (see BioCentury Extra, Thursday, Nov. 9 & Friday Nov. 10).

Stem cells (PDF file) (November 13, 2006)
Draft guidance discussing ownership and licensing of IP acquired by for-profit organizations as a result of state-funded research through the California Institute of Regenerative Medicine (CIRM).

Breast cancer (November 6, 2006)
NICE guidance for the classification and care of women at risk of familial breast cancer in primary, secondary, and tertiary care.

Drug expenditures (PDF file) (November 6, 2006)
Agency for Healthcare Research and Quality (AHRQ) report on "Trends in Brand Name and Generic Prescribed Medicine Utilization and Expenditures, 1999 and 2003."

Drug approvals (November 6, 2006)
New FDA searchable database for drug approvals.

Ethics (PDF file) (November 6, 2006)
NIH survey assessing NIH employee opinions on the impact of the agency's ethics rules (see BioCentury Extra, Tuesday, Oct. 31).

Generics (PDF file) (November 6, 2006)
Citizen's Petition by MedImmune Inc. asking FDA to refuse to approve any ANDA for generic versions of MEDI's Ethyol amifostine with labeling that omits dosage, administration, and other information related to the consequences of using the drug to reduce the incidence of xerostomia in head and neck cancer patients being treated with radiotherapy.

Hepatitis C (PDF file) (November 6, 2006)
FDA briefing document for the Oct.19-20 meeting of the Antiviral Products Advisory Committee to discuss clinical trial design issues for developing products to treat chronic HCV (see Cover Story).

Influenza (PDF file) (October 30, 2006)
WHO’s Global Vaccine Action Plan, outlining strategies to reduce a potential pandemic influenza vaccine supply gap (see BioCentury Extra, Tuesday Oct. 24).

Incontinence (October 30, 2006)
NICE guidance on the management and treatment of urinary incontinence in women.

Product documentation (October 30, 2006)
Effexor XR: “Dear healthcare professional” letter on reports of overdose occurring in patients taking Effexor venlafaxine to treat major depressive disorder, from Weyeth (WYE), predominantly in combination with alcohol and/or other drugs. (PDF file)
— Menactra - CDC updates to a previous alert regarding reports of Guillain Barre Syndrome (GBS) in patients receiving Menactra meningococcal vaccine from sanofi-aventis Group (Euronext:SAN; SNY).

Biomarkers (October 23, 2006)
FDA briefing documents for the Oct.18-19 meeting of the Advisory Committee for Pharmaceutical Science to discuss the addition of information to the label for tamoxifen about increased risk for breast cancer recurrence in CYP2D6 poor metabolizers (see BioCentury Extra, Thursday, Oct.19).

Drug misuse (October 23, 2006)
— NICE final appraisal determination recommending methadone and buprenorphine as maintenance therapy to manage opioid dependency, and a final appraisal determination recommending naltrexone to treat detoxified formerly opioid-dependent people who are highly motivated to remain in an abstinence program.

HIV (PDF file) (October 23, 2006)
FDA guidance for fixed dose combinations, co-packaged drug products, and single-entity versions of previously approved antiretrovirals to treat HIV.

Product documentation (October 23, 2006)
— Fludara: NICE appraisal consultation document recommending against Fludara fludarabine for the first-line treatment of chronic lymphocytic leukemia (CLL), from Schering AG (FSE:SCH; SHR).
— Gleevec: "Dear Healthcare Professional" letter from Novartis AG (NVS; SWX:NOVN) revising the Precautions section of the label for Gleevec to include occasional cases of severe congestive heart failure and left ventricular dysfunction.
— Velcade: NICE final appraisal determination recommending against Velcade bortezomib to treat progressive multiple myeloma (MM), from Millennium Pharmaceuticals Inc. (MLNM) and Johnson & Johnson (JNJ) (see BioCentury Extra, Friday Oct. 20).

Alzheimer's disease (October 16, 2006)
List of denied appeals made by corporate and patient advocacy groups against recent NICE draft guidance on the use of drugs to treat AD (see BioCentury Extra, Oct. 11).

Genitourinary disease (October 16, 2006)
Draft NICE guidance for the diagnosis, treatment and management of urinary tract infections in children.

Industry development (PDF file) (October 16, 2006)
Study of research & development in the U.S. pharmaceutical industry by the Congressional Budget Office (CBO).

Laboratory testing (PDF file) (October 16, 2006)
FDA guidance on evaluation of out-of-specification (OOS) test results of regulated drugs.

Sexually transmitted disease (October 16, 2006)
Draft NICE guidance on reducing the transmission of sexually transmitted infections (STIs) and the rate of conceptions in women less than 18 years of age.

Product documentation (October 16, 2006)
— Coumadin: A new patient medication guide and reorganization of current safety information for patients taking Coumadin warfarin sodium, an anticoagulant used in the prophylaxis and treatment of thrombosis and embolism from Bristol-Myers Squibb Co. (BMY). (PDF files)

Chronic fatigue syndrome (October 9, 2006)
NICE draft guideline on the diagnosis and management of chronic fatigue syndrome (myalgic encephalomyelitis) in adults and children.

Genomics (October 9, 2006)
Link to the Broad Institute Connectivity Map, a reference collection of gene-expression profiles from human cells treated with active small molecules (see BioCentury Extra, Monday Oct. 2).

MedImmune v. Genentech (PDF file) (October 9, 2006)
Transcripts of the oral arguments from MedImmune Inc. (MEDI) and Genentech Inc. (DNA) in their litigation before the U.S. Supreme Court regarding MEDI’s licensing of DNA’s Cabilly II patent.

Osteoporosis (October 9, 2006)
— NICE appraisal consultation document for secondary prevention recommending for Evista raloxifene as well as Fosamax; Didronel; Actonel; and Protos.

Venous thromboembolism (October 9, 2006)
NICE-commissioned draft report on the prevention of venous thromboembolism in orthopedic surgery and other high-risk surgical procedures.

Breast cancer (October 2, 2006)
NICE guidances recommending for the use of docetaxel and against the use of paclitaxel to treat early breast cancer.

Kidney disease (October 2, 2006)
NICE guidance on improved care for patients with anemia due to chronic kidney disease.

Viral vaccines (PDF file) (October 2, 2006)
Draft FDA guidance on the characterization and qualification of cell substrates and other biological reagents used in producing viral vaccines (see BioCentury Extra, Friday Sept. 29).

Product documentation (October 2, 2006)
Rituxan: NICE guidance recommending that Rituxan rituximab be made available in combination with cyclophosphamide, vincristine, and predinsolone as a first line therapy in treatment-naive patients with symptomatic stage III/IV follicular lymphoma, from Biogen Idec Inc. (BIIB) and Roche (SWX:ROCZ).
Trasylol: FDA statement regarding new safety data not presented at the Sept. 21 meeting of the Cardiovascular and Renal Drugs Advisory Committee, which voted to recommend Trasylol aprotinin for patients undergoing cardiopulmonary bypass during coronary artery bypass graft (CABG) surgery, from Bayer AG (FSE:BAY; BAY).

Product Documentation (September 25, 2006)
— Gemzar: NICE appraisal consultation document for Gemzar gemcitabine to treat metastatic breast cancer, from Eli Lilly and Co. (LLY).
— Trasylol: Briefing document for the Sept. 21 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss the risk/benefit profile for Trasylol aprotinin for patients undergoing cardiopulmonary bypass during coronary artery bypass graft (CABG) surgery, from Bayer AG (FSE:BAY; BAY). (PDF file)

Allergenics (September 18, 2006)
Briefing slides for the Sept. 13 meeting of FDA's Allergenic Products Advisory Committee to discuss the reclassification of class IIIA allergenic products

Clinical trial registries (PDF file) (September 18, 2006)
Memorandum of understanding between FDA, NCI, and clinical trial investigators and sponsors describing the FIREBIRD federal research data registry.

Drug-drug interactions (PDF file) (September 18, 2006)
Draft FDA guidance on conducting drug-drug interaction studies.

FDA budget (September 18, 2006)
Website for The FDA Alliance, which is seeking to increase the agency's budget. (see Cover Story).

Product documentation (September 18, 2006)
— Factive: Briefing documents for the Sept. 12 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss an sNDA for a five-day regimen of Factive gemifloxacin to treat acute bacterial sinusitis (ABS), from Oscient Pharmaceuticals Corp. (OSCI) and LG Life Sciences Ltd.

Diagnostic assays (PDF file) (September 11, 2006)
FDA draft guidance for in vitro diagnostic multivariate index assays (IVDMIAs) (see Ebb & Flow & BioCentury Extra, Wednesday Sept. 6).

Noninferiority trials (PDF file) (September 11, 2006)
Letter from Democratic members of the House Energy and Commerce Committee and Sen. Chuck Grassley (R-Iowa) asking the Government Accountability Office (GAO) to study FDA's use of noninferiority studies to approve antibiotics and other drugs (see BioCentury Extra, Thursday Sept. 7).

Product documentation (September 11, 2006)
— Abraxane: FDA briefing documents for the Sept. 7 meeting of FDA's Oncologic Drugs Advisory Committee to review an NDA for Abraxane paclitaxel as an adjuvant treatment of node-positive breast cancer, from Abraxis BioScience Inc. (ABBI). (PDF file)
— Genasense: FDA briefing document for the Sept. 6 meeting of FDA's Oncologic Drugs Advisory Committee to review an NDA for Genasense oblimersen to treat relapsed/refractory chronic lymphocytic leukemia (CLL), from Genta Inc. (GNTA) (see "No Renaissance for Genasense"). (PDF file)
— Fragmin: FDA briefing document for the Sept. 6 meeting of FDA's Oncologic Drugs Advisory Committee to review an NDA for Fragmin dalteparin to prevent the recurrence of venous thromboembolism (VTE) in cancer patients. (PDF file)

NICE topic referrals (September 4, 2006)
NICE announcement of new public health topics, technology appraisals and clinical guidelines referred to it by NHS.

Product documentation (September 4, 2006)
— Gestiva - Briefing documents and questions for the Aug. 29 meeting of FDA's Advisory Committee for Reproductive Health Drugs to discuss an NDA for Gestiva to prevent premature birth, from Adeza Biomedical Corp. (ADZA). (PDF files)

Drug registration (PDF file) (August 28, 2006)
Report of the HHS Office of Inspector General on FDA’s national drug code directory (see BioCentury Extra, Wednesday Aug. 23).

Emergency care (PDF file) (August 28, 2006)
Draft FDA guidance for research in emergency settings involving an exception from informed consent requirements.

Myocardial infarction (August 28, 2006)
NICE first draft guidance for secondary prevention in primary and secondary care for patients following a myocardial infarction (MI).

Nanotechnology (PDF file) (August 28, 2006)
Memorandum of understanding between FDA, NCI and the National Institute of Standards and Technology (NIST) for the Nanotechnology Characterization Laboratory (NCL) and related nanotechnology activities.

Product documentation (August 28, 2006)
Avastin/Erbitux: NICE final appraisal determination recommending that Avastin bevacizumab from Genentech Inc. (DNA) and Erbitux cetuximab from partners ImClone Systems Inc. (IMCL) and Merck KGaA (FSE:MRK) not be made available to NHS patients with metastatic colorectal cancer (see BioCentury Extra, Monday Aug. 21).
Cinacalcet: NICE second appraisal document recommending against cinacalcet hydrochloride from Amgen Inc. (AMGN) to treat secondary hyperparathyroidism in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Dexedrine: “Dear Healthcare” letter from GlaxoSmithKline plc (LSE:GSK; GSK), warning that misuse of Dexedrine dextroamphetamine to treat ADAD and narcolepsy might cause sudden death and serious cardiovascular adverse events. (PDF file)
Herceptin: NICE guidance recommending use of Herceptin trastuzumab from Genentech Inc. (DNA) and Roche (SWX:ROCZ) to treat women with early stage HER2-positive breast cancer (see BioCentury Extra, Wednesday Aug. 23).

Antimicrobials (PDF file) (August 21, 2006)
FDA amendment to food additive regulations to include the antimicrobial use of bacteriophages as safe food in ready-to-eat meat.

HIV (PDF file) (August 21, 2006)
2006 recommendations on the treatment of HIV in adults, published by the U.S. panel of the International AIDS Society in the Journal of the American Medical Association.

Breast cancer (August 14, 2006)
NICE final appraisal determination recommending for Arimidex anastrozole from AstraZeneca plc (LSE:AZN; AZN); Aromasin exemestane from Pfizer Inc. (PFE) and Femara letrozole from Novartis AG (NVS; SWX:NOVN) to be used as adjuvants to treat early estrogen receptor-positive invasive breast cancer in postmenopausal women.

Nanotechnology (PDF file) (August 14, 2006)
FDA request for comments regarding an Oct. 10 meeting on the uses of nanotechnology materials in products regulated by the agency, including human and animal drugs, human biologics and medical devices.

Post-marketing requirements (PDF file) (August 14, 2006)
H.R. 5922, introduced by Rep. Ed Markey (D-Mass.), which would give HHS authority to impose postmarket study requirements and tighten regulation of drugs that receive accelerated approval (see BioCentury Extra, Tuesday Aug. 8).

Sarbanes-Oxley (PDF file) (August 14, 2006)
SEC announces proposals intended to provide relief to smaller public companies from compliance with Section 404 of SOX (see BioCentury, Aug. 14).

Product documentation (August 14, 2006)
— Rituxan: NICE final appraisal determination recommending for Rituxan rituximab from Biogen Idec Inc. (BIIB), Genentech Inc. (DNA) and Roche (SWX:ROCZ) in combination with cyclophosphamide, vincristine and prednisolone to treat symptomatic Stage III/IV follicular lymphoma in previously untreated patients.

CDC-FDA cooperation (PDF file) (August 7, 2006)
Memorandum of understanding outlining procedures for cooperation and information exchange between the agencies.

Formulation (PDF file) (August 7, 2006)
FDA guidance impurities in new drug products, prepared as ICH guidance Q3A(R).

Bipolar disorder (July 31, 2006)
NICE guidance for the management of bipolar disorder in adults, children and adolescents, in primary and secondary care.

Breast cancer (July 31, 2006)
NICE final appraisal determinations recommending against Taxol paclitacel from Bristol-Myers Squibb Co. (BMY) as an adjuvant treatment of women with early node-positive breast cancer, and recommending for adjuvant treatment using Taxotere docetaxel from sanofi-aventis Group (Euronext:SAN; SNY) with doxorubicin and cyclophosphamide to treat women with node-positive breast cancer.

Clinical trials (July 31, 2006)
Technical reports from the National Cancer Institute's Biometric Research Branch, including papers on adaptive enrichment techniques by Richard Simon (see Cover Story).

Drug spending (PDF files) (July 31, 2006)
— French report suggesting the French spend more on drugs per inhabitant than the Germans, British, Italians and Spanish.
— U.K. Department of Health's ninth report to Parliament on the Pharmaceutical Price Regulation Scheme (PPRS).

Esophageal cancer (July 31, 2006)
— NICE interventional procedures consultation documents for photodynamic therapy for early esophageal cancer and for palliative photodynamic therapy for advanced disease.

Psoriasis (July 31, 2006)
NICE guidance for the use of Enbrel etanercept from Amgen Inc. (AMGN) and Raptiva efalizumab from Genentech Inc. (DNA) and Serono S.A. (SWX:SEO; SRA) to treat adults with psoriasis.

Psoriatic arthritis (July 31, 2006)
NICE guidance for the use of Enbrel from Amgen (AMGN) and Remicade infliximab from Johnson & Johnson (JNJ) and Schering-Plough Corp. (SGP) to treat adults with psoriatic arthritis.

Transplant (July 31, 2006)
NICE interventional procedures consultation for living donor liver transplantation.

Product documentation (July 31, 2006)
— Velcade: NICE preliminary appraisal suggesting that Velcade bortezomib monotherapy, from Millennium Pharmaceuticals Inc. (MLNM), should not be used to treat multiple myeloma (MM) except in clinical studies (see BioCentury Extra, Wednesday, July 26).

Influenza (July 24, 2006)
— Public comments on two draft FDA guidance documents covering the development of seasonal and pandemic influenza vaccines (see BioCentury Extra, Wednesday, July 19).

Stem cells (PDF file) (July 24, 2006)
Final version of the Stem Cell Research Enhancement Act of 2005, passed by the House and Senate and vetoed by President Bush (see BioCentury Extra, Wed., July 19).

eSubmissions (PDF file) (July 17, 2006)
FDA guidance for submitting lot release protocols in electronic format to the Center for Biologics Evaluation and Research (CBER).

Hypercholesterolemia (PDF file) (July 17, 2006)
Draft NICE scope for a guideline on the identification and management of patients with familial hypercholesterolemia.

Postmarketing commitments (PDF file) (July 17, 2006)
Report from HHS Office of Inspector General, suggesting that monitoring postmarketing study commitments is not a top priority at FDA (see BioCentury Extra, Monday July 10).

Reimbursement (July 17, 2006)
Revised guidance on Coverage with Evidence Development (CED) from the Centers for Medicare and Medicaid Services (CMS), plus public comments on the draft guidance (PDF file) (see BioCentury, July 17).
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Sarbanes-Oxley (PDF file) (July 17, 2006)
SEC "concept release" soliciting public comment on guidance it is developing to help management comply with Sarbanes-Oxley Act Section 404 requirements for internal control structure and procedures for financial reporting (see BioCentury, July 17).

Product documentation (July 17, 2006)
Nabi-HB: FDA briefing document for the July 13 meeting of the Blood Products Advisory Committee to review a BLA for IV Nabi-HB to prevent recurrence of HBV infection after liver transplant, from Nabi Biopharmaceuticals (NABI) (see BX). (PDF file)

Product documentation (July 10, 2006)
— Ketek: FDA adds liver toxicity warnings and strengthens myasthenia gravis warnings to the label for antibiotic Ketek telithromycin, from sanofi-aventis Group (Euronext:SAN; SNY) (see BioCentury, July 3).
— Nabi-HB IV: Notice of meeting of FDA's Blood Products Advisory Committee to review a BLA for Nabi-HB IV human hepatitis B immune globulin to prevent recurrence of HBV in liver transplant patients, from Nabi Biopharmaceuticals (NABI). (PDF file)

Atrial fibrillation (July 3, 2006)
NICE guidelines for the identification and management of atrial fibrillation.

Brain tumors (July 3, 2006)
NICE guidance on improving outcomes for patients with brain and other CNS tumors.

Genetic data (July 3, 2006)
Epigenetic data on human chromosomes 6, 20, and 22 and the website of the Human Epigenome Project (HEP) (see BioCentury Extra, Monday June 26).

Hypertension (July 3, 2006)
NICE updated guidance for the management of hypertension in adults.

Orphan drugs PDF file (July 3, 2006)
European Commission's five-year report on the impact of Orphan medicine legislation (see BioCentury Extra, Monday June 26).

Product documentation (July 3, 2006)
— Alimta: NICE final appraisal determination for Alimta pemetrexed disodium to treat malignant pleural mesothelioma, from Eli Lilly and Co. (LLY).
— Aptivus: "Dear Healthcare Professional" letter from Boehringer Ingelheim Corp. reporting intracranial hemorrhage events (ICH) in HIV patients treated with Aptivus tipranavir, and revised labeling. (PDF files)
— Taxotere: NICE guidance on Taxotere docetaxel to treat hormone refractory prostate cancer, from sanofi-aventis Group (Euronext:SAN; SNY).

Enforcement (June 26, 2006)
FDA’s Office of Regulatory Affairs Bioresearch Monitoring (BIMO) information page (see BioCentury, June 26)).

GM foods (PDF file) (June 26, 2006)
FDA guidance on safety of proteins produced from bioengineered plants for use as food.

LabCorp. V. Metabolite (PDF file)
Dissent from three U.S. Supreme Court justices in LabCorp. v. Metabolite Laboratories Inc., in which the majority decided the court’s decision to hear the case was “granted improvidently” (see BioCentury Extra, Friday June 23).

PMAs (PDF files) (June 26, 2006)
Review and inspection for PMAs under the Bioresearch Monitoring (BIMO) process.

Product documentation (June 26, 2006)
Exubera: NICE appraisal consultation document adjusting the recommended prescribing protocol for Exubera inhaled insulin for the treatment of Type I and Type II diabetes, from Pfizer Inc. (PFE) (see BioCentury Extra, Thursday June 22).

Product documentation (June 12, 2006)
— Herceptin: NICE draft guidance for use of Herceptin in the U.K.
— Omniscan: "Dear Healthcare Professional" letter from GE Healthcare Ltd. reporting cases of nephrogenic fibrosing dermopathy or nephrogenic systemic fibrosis (NSF/NFD) in patients with renal failure who underwent magnetic resonance angiography (MRA) with Omniscan gadodiamide. (PDF file)

Product documentation (June 5, 2006)
— Sprycell dasatinib: FDA briefing documents for the June 2 meeting of the Oncologic Drugs Advisory Committee to review Sprycel dasatinib to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), from Bristol-Myers Squibb Co. (BMY) (see "Sprycel Easy to Sell"). (PDF file)

Alzheimer’s disease (PDF file) (May 29, 2006)
NICE final appraisal determination for Aricept donepezil from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Pfizer Inc. (PFE); Razadyne galantamine from Shire Pharmaceuticals Group plc (LSE:SHP; SHPGY) and Johnson & Johnson (JNJ); Exelon rivastigmine from Novartis AG (NVS; SWX:NOVN), and Ebixa (Namenda) memantine from Forest Laboratories Inc. (FRX) and H. Lundbeck A/S (CSE:LUN) to treat Alzheimer’s disease (AD).

Breast cancer (May 29, 2006)
NICE appraisal consultation document for hormonal therapies for the adjuvant treatment of early estrogen-receptor-positive breast cancer.

Sarbanes-Oxley (PDF file) (May 29, 2006)
“The Competitive and Open Markets that Protect and Enhance the Treatment of Entrepreneurs (COMPETE) Act (H.R. 5405), introduced in the House by Tom Feeney (R-Fla.) (see BioCentury Extra, Thursday, May 18).

Breast cancer (May 22, 2006)
NICE draft for consultation on the treatment of females at risk of familial breast cancer in primary, secondary, and tertiary care.

eBay (PDF file) (May 22, 2006)
Unanimous Supreme Court opinion written by Justice Clarence Thomas, and two concurring opinions, in eBay Inc. v. MercExchange LLC.

Hepatitis C (May 22, 2006)
NICE final appraisal determination for Viraferon interferon alfa-2b and Rebetol ribavirin to treat mild chronic HCV, from Schering-Plough Corp. (SGP).

Product documentation (May 22, 2006)
— Exelon: Briefing documents for the May 17 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee to discuss the inclusion of mild to moderate dementia associated with Parkinson's disease (PD) in the label for Exelon rivastigmine from Novartis AG (NVS; SWX:NOVN), which is marketed to treat dementia associated with Alzheimer's disease (AD) (see BioCentury Extra, Wednesday, May 17).
— Gardasil: Briefing documents for the May 18 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss the use of Gardasil human papillomavirus (HPV) vaccine from Merck & Co. Inc. (MRK).
— Paxil: "Dear Healthcare Professional" letter from GlaxoSmithKline plc (LSE:GSK; GSK) advising of label changes to include the Clinical Worsening and Suicide Risk section for Paxil and Paxil CR paroxetine to treat depression, anxiety and related psychiatric disorders (see BioCentury Extra, Friday, May 12). (PDF file)

Pediatric trials (PDF file) (May 15, 2006)
Draft FDA guidance on the process for handling trials that include children as subjects.

Vaccines (PDF file) (May 15, 2006)
FDA notice of a May 19 meeting of the Vaccines and Related Biological Products Advisory Committee's research review subcommittee to hear presentations of research programs at the Office of Vaccines Research and Review (OVRR).

cGMP regulations (May 8, 2006)
FDA announcement that it is withdrawing a direct final rule on current good manufacturing practice (cGMP) regulations for Phase I products because of "significant adverse comments." (see BioCentury Extra, Monday. May 1). (PDF file)

Patents (May 8, 2006)
European Court of Justice ruling against MIT that patent extensions via Supplementary Protection Certificates are not available to combination products with only one active ingredient, in a case brought by the university regarding Gliadel for brain cancer (see BioCentury Extra, Friday May 5).

Urinary incontinence (May 8, 2006)
NICE draft consultation for the management of urinary incontinence in women.

Colon cancer (May 1, 2006)
NICE technology appraisal for Xeloda capecitabine from Roche (SWX:ROCZ) and Eloxatin oxaliplatin from sanofi-aventis Group (Euronext:SAN; SNY), a therapeutic regimen also called XELOX, for the adjuvant treatment of stage III Dukes' C colon cancer.

Glioma (PDF file) (May 1, 2006)
NICE final appraisal determination for Gliadel wafer carmustine implant from Link Pharmaceuticals Ltd. and Temodal temozolomide from Schering-Plough Corp. (SGP) to treat newly diagnosed high-grade glioma.

Product documentation (May 1, 2006)
— Cellegesic: Briefing documents for FDA's Cardiovascular and Renal Drugs Advisory Committee meeting on April 25 to discuss an NDA for Cellegesic nitroglycerin ointment to treat pain associated with chronic anal fissures, from Cellegy Pharmaceuticals Inc. (CLGY) (see "Cellegesic Splits its Panel").
— Exubera: NICE preliminary appraisal recommending against Exubera inhaled insulin to treat Type I and Type II diabetes, from Pfizer Inc. (PFE) (see Cover Story).

Anemia (PDF file) (April 24, 2006)
NICE draft guideline for second consultation on anemia management in people with chronic kidney disease.

Hypertension (PDF file) (April 24, 2006)
Draft FDA guidance for outcome claims for drugs to treat hypertension.

SBIRs (PDF file) (April 24, 2006)
Government Accountability Office (GAO) report on venture capital-backed companies receiving SBIRs (see BioCentury Extra, Tuesday, April18).

Product documentation (April 24, 2006)
— TGN1412: MHRA webpage containing links to documents pertaining to its interim investigation into the adverse reactions experienced by patients in a Phase I trial of TGN1412 to treat B cell chronic lymphocytic leukemia (CLL), from TeGenero Immuno Therapeutics AG, plus a link (PDF file) to the ICH guideline on preclinical safety evaluation of biotechnology-derived pharmaceuticals (see "The TeGenero Impact" ).

Nanotechnology (April 17, 2006)
FDA call for comments to plan a public meeting on the use of nanotechnology materials in FDA-regulated products, to be held in the fall.

Pricing (April 17, 2006)
Proceedings of European Generic Medicines Association (EGA) seminar on generic pricing and reimbursement systems in Europe.

Sarbanes-Oxley (PDF file) (April 10, 2006)
A letter from Biotechnology Industry Organization (BIO) and other trade organizations endorsing an SEC advisory committee's draft recommendations for reforms of the Sarbanes-Oxley Act (see BioCentury Extra, Monday, April. 3).

Product documentation (April 10, 2006)
Macugen: "Dear Healthcare" letter to include reports of anaphylaxis/anaphylactoid reactions in patients taking Macugen pegaptanib to treat neovascular age-related macular degeneration (AMD) from Pfizer Inc. (PFE) and OSI Pharmaceuticals Inc. (OSIP) (see BioCentury Extra, Friday, April 7). (PDF file)

Clinical Trial Sponsors (PDF file) (April 3, 2006)
FDA guidance on the establishment and operation of clinical trial data monitoring committees.

ADHD (March 27, 2006)
— FDA briefing documents and questions (PDF file) for the March 22 meeting of the Pediatric Advisory Committee to discuss the pediatric use of ADHD drugs.
— FDA briefing documents for the March 23 meeting of the Psychopharmacologic Drugs Advisory Committee to discuss Sparlon modafinil to treat children and adolescents with ADHD, from Cephalon Inc. (CEPH).

ADHD (March 20, 2006)
FDA briefing documents for a March 22 meeting of the Pediatric Advisory Committee to discuss psychiatric adverse events in patients taking ADHD drugs (see BioCentury Extra, Wednesday, March.15).

Combination therapies (PDF file) (March 20, 2006)
FDA guidance concerning non-clinical safety evaluation of drug or biologic combinations.

Critical Path (PDF file) (March 20, 2006)
FDA list of 76 priority Critical Path projects (see BioCentury Extra, Thursday, March 16).

Prescription drugs (PDF file) (March 20, 2006)
FDA guidance on donating prescription drug samples to free clinics.

Product documentation (March 20, 2006)
Ontak: “Dear Healthcare Professional” letter, concerning the inclusion of risk of visual loss in the label for Ontak denileukin to treat cutaneous T cell lymphoma (CTCL), from Ligand Pharmaceuticals Inc. (LGND). (PDF file)

Product documentation (March 13, 2006)
— Tequin: Dear Healthcare Professional letter announcing a label change to include serious cases of hypo- and hyperglycemia associated with Tequin gatifloxacin to treat bacterial infections, from Bristol-Myers Squibb Co. (BMY). (PDF files)
— Tysabri: FDA briefing documents for the March 7-8 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee to discuss the sBLA for Tysabri natalizumab to treat multiple sclerosis (MS), from Biogen Idec Inc. (BIIB) and Elan Corp. plc (ELN) (see Cover Story).

Product documentation (March 6, 2006)
Cubicin: Briefing documents for the March 6 meeting of FDA’s Anti-Infective Drugs Advisory Committee to discuss an sNDA for Cubicin daptomycin to treat bacteremia caused by Staphylococcus aureus, from Cubist Pharmaceuticals Inc (CBST) (see BioCentury Extra, Friday, March 3).
Tracleer: Actelion Ltd. (SWX:ATLN) notice to healthcare professionals of changes to the prescribing information for Tracleer bosentan based on cases of hepatotoxity in patients treated for pulmonary arterial hypertension (PAH). (PDF file)

Patents (February 20, 2006)
Amendment to the Indian Patent Act governing pharmaceuticals (see "Testing IP Reform in India").

Pediatrics (PDF file) (February 20, 2006)
FDA guidance for nonclinical safety studies of therapeutics to treat pediatric patients.

Vaccines (PDF file) (February 20, 2006)
FDA guidance for toxicity studies for investigational preventive and therapeutic vaccines to treat infectious diseases.

Product documentation (February 20, 2006)
— Tequin: Label revision to include reports of hypoglycemia and hyperglycemia in diabetic patients taking Tequin gatifloxacin to treat respiratory tract and other infections, from Bristol-Myers Squibb Co. (BMY). (PDF file)

ADHD (February 13, 2006)
Briefing documents for the Feb. 9 meeting of FDA’s Drug Safety and Risk Management Advisory Committee to discuss the design of studies to characterize the safety of ADHD drugs (see BioCentury Extra, Friday Feb. 10).

Critical Path (February 13, 2006)
— “Opportunities for Improving the Drug Development Process, Results from a survey of Industry and the FDA,” by Ernst Berndt, et al. (see BioCentury, Feb. 10).
FDA proposal for a CRADA with Conformia Software Inc. to collect information using focus groups to determine what factors may influence pharmaceutical development (see BioCentury Extra, Friday Feb. 10). (PDF file)

Pharmacogenetics (PDF file) (February 13, 2006)
Draft FDA guidance for pharmacogenetic tests and genetic testing for heritable markers (see BioCentury Extra, Wednesday Feb. 8).

Clinical investigators (PDF files) (February 6, 2006)
FDA guidance for the inspection of clinical investigators and for inspections for IRBs conducted under FDA's Bioresearch Monitoring (BIMO) Program.

IRBs (PDF file) (February 6, 2006)
FDA guidance for sponsors and investigators seeking a waiver of IRB requirements for drug and biological product studies.

Clinical trials (PDF file) (February 6, 2006)
Draft FDA guidance on use of patient-reported outcome measures as endpoints and to support labeling claims.

Proposed IRS Section 409A rule (January 30, 2006)
Proposed IRS rules for valuing stock options at private companies.

Product documentation (January 30, 2006)
— Droxia/Hydria: "Dear Healthcare Provider" letter concerning cutaneous vasculitic toxicities in patients with myeloproliferative disorders during therapy with Droxia and Hydria hydroxyurea from Bristol-Myers Squibb Co. (BMY). (PDF files)

Product documentation (January 23, 2006)
Xenical: Briefing documents for a Jan. 23 joint meeting of FDA's Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee to discuss whether Xenical orlistat, from Roche (SWX:ROCZ), will be properly used as an over-the-counter (OTC) drug to promote weight loss.

Product documentation (PDF file) (January 16, 2006)
— Clozaril: "Dear Healthcare" letter from Novartis AG (NVS; SWX:NOVN) regarding an updated label warning of safety issues for antipsychotic drug Clozaril clozapine related to dementia-related psychosis, parlytic ileus, hypercholesterolemia and interaction with citalopram.

ADHD (PDF file) (January 9, 2006)
FDA announcement of a Feb. 9-10 meeting of the Drug Safety and Risk Management Advisory Committee to discuss approaches that could be used to study whether ADHD drugs increase cardiovascular risk in children and adults.

Toxicology (PDF file) (January 9, 2006)
Draft FDA guidance for recommended approaches to integration of genetic toxicology study results.

Product documentation (PDF file) (January 9, 2006)
Avandia/Avandamet/Avandaryl: "Dear Healthcare Provider" letter from GlaxoSmithKline plc (LSE:GSK; GSK) warning of new onset and worsening diabetic macular edema in patients taking Avandia rosiglitazone, Avandamet rosiglitazone/metformin and Avandaryl rosiglitazone/glimepiride to treat Type II diabetes (see BioCentury Extra, Thursday Jan. 5).

 

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