Product Documentation (PDF files) (December 19, 2005)
� RotaTeq: Briefing documents for Dec. 14 meeting of FDA’s Vaccines & Related Products Advisory Committee Meeting to discuss RotaTeq rotavirus vaccine to protect against rotavirus gastroenteritis, from Merck & Co. Inc. (MRK).
� Zostavax: Briefing documents for Dec. 15 meeting of FDA’s Vaccines & Related Products Advisory Committee Meeting to discuss Zostavax live zoster vaccine to prevent herpes zoster (shingles) and postherpetic neuralgia (PHN), and to reduce acute and chronic shingles-associated pain in adults, from Merck & Co. Inc. (MRK).

Diagnostics (PDF file) (December 12, 2005)
Draft FDA guidance covering nucleic acid-based in vitro diagnostic devices for detection of microbial pathogens.

Risk management (PDF file) (December 12, 2005)
FDA announcement of public workshop on April 28, 2006, to discuss risk management, corrective and preventive actions, and training.

Product Documentation (December 5, 2005)
� Aranesp/Epogen: Dear Healthcare Professional letter from Amgen Inc. (AMGN) regarding an updated label warning that pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp darbepoetin alfa treat chemotherapy-induced anemia and with Epogen epoetin alfa to treat anemia in kidney disease patients. (PDF file)
� Daytrana: Briefing documents for the Dec. 2 meeting of FDA's Psychopharmacologic Drugs Advisory Committee to discuss an NDA for the Daytrana methylphenidate transdermal system to treat pediatricADHD, from Shire Pharmaceuticals Group plc (LSE:SHP;SHPGY) and Noven Pharmaceuticals Inc. (NOVN) (see BioCentury, Dec. 5).
� Flomax: Dear Doctor letter from Boehringer Ingelheim Pharmaceuticals Inc. warning that intraoperative floppy iris syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers, including Flomax tamsulosin to treat benign prostatic hyperplasia (BPH). (PDF file)
� Procrit: Dear Healthcare Professional letter from Johnson & Johnson (JNJ) regarding an updated label warning that pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Procrit epoetin alfa to treat chemotherapy-induced anemia. (PDF file)

Hormone products (PDF file) (November 21, 2005)
Draft FDA labeling guidance for noncontraceptive estrogen drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms.

Plan B (PDF file) (November 21, 2005)
Government Accountability Office (GAO) report on the investigation of FDA's not approvable letter for Plan B levonorgestrel contraceptive from Barr Laboratories, Inc. (BRL) (see BioCentury Extra, Monday Nov. 14).

Product Documentation (November 21, 2005)
� Tamiflu: Briefing documents from FDA's Pediatric Advisory Committee meeting on Nov. 18 to discuss adverse events for a number of drugs granted pediatric exclusivity, including influenza vaccine Tamiflu oseltamivir from Gilead Sciences Inc. (GILD) and Roche (SWX:ROCZ) (see BioCentury Extra, Friday Nov.18).

Critical Path (November 14, 2005)
March 2004 FDA white paper on the Critical Path Initiative (see Cover Story).

Product Documentation (November 14, 2005)
� Amevive: "Dear Healthcare Provider" letter from Biogen Idec Inc. (BIIB) and FDA containing a contraindication for psoriasis drug Amevive alefacept in patients with HIV.

Electronic Drug Labels (November 7, 2005)
National Library of Medicine DailyMed website for drug label information (see BioCentury Extra, Wednesday, Nov. 2).

Product Documentation (November 7, 2005)
� Avinza: Dear Healthcare Professional letter from Ligand Pharmaceuticals Inc. (LGND) regarding Black Box warning that patients should not consume alcohol while taking Avinza morphine sulfate for chronic moderate to severe pain. (PDF file)

Product Documentation (October 31, 2005)
� Zevalin: Warning letter from Biogen Idec Inc. (BIIB) regarding severe cutaneous or mucocutaneous reactions in patients treated with Zevalin ibritumomab for non-Hodgkin's lymphoma (NHL). (PDF file)

Non-Antiarrhythmic Drugs (PDF file) (October 24, 2005)
FDA guidance for the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization.

Psychopharmacologic drugs (PDF file) (October 24, 2005)
Announcement of Oct. 25-26 meeting of FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) to discuss acute and long-term efficacy for psychiatric drugs (see BioCentury Extra, Tuesday Oct. 18).

Ventricular Repolarization (PDF file) (October 24, 2005)
FDA guidance for nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization.

Product Documentation (October 24, 2005)
� Cymbalta: Eli Lilly (LLY) "Dear Healthcare Professional" letter and updated label extending the precaution concerning hepatotoxicity in patients with substantial alcohol use being treated with Cymbalta duloxetine to treat major depressive disorder and diabetic peripheral neuropathic pain (see BioCentury Extra, Monday Oct. 17). (PDF file)

Clinical trial websites (October 17, 2005)
HHS guidance for Institutional Review Board (IRB) review of information provided to human research subjects through clinical trial websites.

Duras Capital (PDF file) (October 17, 2005)
SEC complaint filed against Durus Capital Management and its principals.

PDUFA (PDF file) (October 17, 2005)
Issues outline for a Nov. 14 public hearing by FDA to seek comments and suggestions for renewal of the Prescription Drug User Fee Act (see BioCentury Extra, Friday Oct. 14).

Product Documentation (October 10, 2005)
� Menactra: Link to the Vaccine Adverse Event Reporting System (VAERS) (see BioCentury Extra, Monday, Oct. 3).

Clinical trial registries (PDF file) (October 3, 2005)
Comments from the Biotechnology Industry Organization (BIO) to the World Health Organization regarding WHO's International Clinical Trials Registry Platform.

Product Documentation (PDF files) (October 3, 2005)
� Exjade: Briefing documents from for the Sept. 29 meeting of FDA's Blood Products Advisory Committee to discuss an NDA Exjade deferasirox from Novartis AG (NVS; SWX:NOVN) to treat chronic iron overload due to blood transfusions in patients six years of age or older.

Andrew von Eschenbach (September 26, 2005)
Website for NCI’s Academic Public-Private Partnership Program (AP4), launched under now-FDA Acting Commissioner Andrew von Eschenbach (see Cover Story).

Post-approval studies (PDF file) (September 19, 2005)
Draft FDA guidance on handling post-approval studies imposed on a PMA by the Center for Devices and Radiological Health (CDRH).

Product Documentation (September 19, 2005)
� Erbitux: "Dear Healthcare Provider" letter warning of an increased incidence of hypomagnesemia in recent trials and announcing label changes recommending electrolyte monitoring for Erbitux cetuximab to treat colorectal cancer, from ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co. (BMY) (see BioCentury Extra, Wednesday, Sept. 14). (PDF file)
� Revlimid: FDA briefing documents for Sept. 14 meeting of the Oncologic Drugs Advisory Committee (ODAC) to review Revlimid lenalidomide to treat patients with myelodysplastic syndrome (MDS) with 5q chromosomal deletions, from Celgene Corp. (CELG) (see BioCentury Extra, Tuesday Sept. 12).
� Tarceva: FDA briefing documents for Sept. 13 meeting of the Oncologic Drugs Advisory Committee (ODAC) to review Tarceva erlotinib to treat advanced or metastatic pancreatic carcinoma in combination with gemcitabine, from OSI Pharmaceuticals Inc. (OSIP) and Genentech Inc. (DNA) (see BioCentury Extra, Monday Sept.12).
� Xinlay: FDA briefing documents for Sept. 13 meeting of the Oncologic Drugs Advisory Committee (ODAC) to review Xinlay atrasentan to treat metastatic hormone-refractory prostate cancer in men with confirmed metastases, from Abbott Laboratories (ABT) (see BioCentury Extra, Monday Sept.12).

Product Documentation (September 12, 2005)
� Exubera: FDA briefing documents for the Sept. 8 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to review Exubera inhaled insulin powder to treat adults with Type I and Type II diabetes, from Pfizer Inc. (PFE), sanofi-aventis (Euronext:SAN; SNY), and Nektar Pharmaceuticals Co. Inc. (NKTR).
� Orencia: FDA briefing documents for the Sept. 6 meeting of the Arthritis Drugs Advisory Committee to review Orencia abatacept to treat rheumatoid arthritis (RA), from Bristol-Myers Squibb Co. (BMY).
� Pargluva: FDA briefing documents for the Sept. 9 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to review Pargluva muraglitazar to treat Type II diabetes, from Bristol-Myers Squibb Co. (BMY) and Merck & Co. Inc. (MRK).

Protein imaging (September 5, 2005)
Website for Protein Atlas, a database from the Swedish Human Proteome Resource Program containing images of the locations of different proteins in human cells and tissues (see BioCentury Extra, Wednesday Aug. 31).

Product Documentation (PDF files) (September 5, 2005)
� Abatacept: FDA briefing documents for the Sept. 6 meeting of the Arthritis Advisory Committee to discuss Abatacept (CTLA4-Ig) to treat rheumatoid arthritis, from Bristol-Myers Squibb Co. (BMY) (see BioCentury Extra, Friday, Sept. 2).
� Herceptin: "Dear Healthcare Professional" letter from Genentech Inc. (DNA) including data on cardiotoxicity seen in recent trials for Herceptin trastuzumab treat metastatic breast cancer (see BioCentury Extra, Thursday, Sept. 1).

Conflict of interest (August 29, 2005)
Final NIH rules governing financial relationships between its employees and biotech and pharmaceutical companies (see BioCentury Extra, Friday Aug. 26).

User fees (PDF file) (August 8, 2005)
Fiscal year 2006 PDUFA fees (see BioCentury Extra, Tuesday, Aug. 2).

Product Documentation: (August 8, 2005)
� MT 100: Briefing documents for the Aug. 4, 2005, meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee to review MT 100 naproxen/metoclopramide to treat migraine, from Pozen Inc. (POZN) (see Cover Story).

Product Documentation (August 1, 2005)
� Bexxar/Zevalin: CMS announcement of continued off-label coverage of Zevalin ibritumomab tiuxetan from Biogen Idec Inc. (BIIB) and Bexxar tositumomab from GlaxoSmithKline plc (LSE:GSK;GSK) to treat non-Hodgkin's lymphoma (NHL).

Safety (PDF file) (July 25, 2005)
CDER guidance regarding the estimation of the maximum safe starting dose in adult healthy volunteers enrolled in clinical trials.

Product Documentation (PDF files) (July 25, 2005)
� Natrecor: Dear Healthcare Provider letter concerning the recommendations of an expert panel of cardiology and heart failure clinicians with regard to recent questions raised about worsened renal function and mortality for patients using Natrecor nesiritide, from the Scios Inc. subsidiary of Johnson & Johnson (JNJ).
� Raptiva: Dear Healthcare Provider letter and revised label concerning reports of adverse events including immune-mediated hemolytic anemia, thrombocytopenia and serious infections for patients taking Raptiva efalizumab to treat psoriasis, from Genentech Inc. (DNA) and Serono S.A. (SWX:SEO; SRA).

Patent claims (PDF file) (July 18, 2005)
U.S. Court of Appeals for the Federal Circuit ruling on legal standards for defining terms used in patent claims (see BioCentury Extra, Wednesday July 13).

Emergency use (PDF file) (July 4, 2005)
Draft FDA guidance for the emergency use authorization of medical products.

Gingivitis (PDF file) (July 4, 2005)
Draft FDA guidance on the development and evaluation of drugs for the treatment and prevention of gingivitis.

U.K. health (July 4, 2005)
NHS backgrounder on its new Institute for Innovation and Improvement.

Product Documentation (June 20, 2005)
� Bidil: Briefing documents for the June 16 meeting of the cardiovascular and Renal Drugs Advisory Committee to review BiDil to treat heart failure in black patients.

Product Documentation (PDF file) (June 13, 2005)
� Sustiva: “Dear Healthcare Professional” letter from Bristol-Myers Squibb Co. (BMY) advising of a strengthened warning label for pregnant women taking on Sustiva efavirenz to treat HIV.

Antiviral drugs (PDF file) (June 6, 2005)
Draft FDA guidance on developing antiviral drugs, conducting virology studies, and submitting the data to the agency.

Autologous chondrocyte implantation (June 6, 2005)
Updated NICE guidance on the use of ACI to treat cartilage defects in knee joints.

Cancer (June 6, 2005)
Updated NICE guidance on treatments for advanced ovarian cancer.

Prescribing instructions (PDF file) (June 6, 2005)
Draft FDA guidance on developing useful consumer medication information.

Product Documentation (PDF files) (June 6, 2005)
� Novantrone: "Dear Healthcare Professional" letter from Serono S.A. (SWX:SEO;SRA) concerning revisions made to the label for Novantrone mitoxantrone to treat multiple sclerosis (MS).
� Pulminiq: Briefing documents for the June 6 meeting of FDA's Pulmonary Advisory Committee to review Pulminiq inhaled cyclosporine to prevent chronic lung transplant rejection, from Chiron Corp. (CHIR) (see BioCentury Extra, Friday June 3).

Product Documentation (PDF files) (May 23, 2005)
� Aredia/Zometa: “Dear Healthcare Professional” letter from Novartis (NVS; SWX:NOVN) regarding risk of osteonecrosis of the jaw (ONJ) in cancer patients receiving Aredia pamidronate and Zometa zoledronic to treat bone metastases and bone complications.
� Natrecor: “Dear Healthcare Professional” letter regarding additions to the warning section of the label for Natrecor nesiritide to treat acutely decompensated congestive heart failure (ADCHF) patients who have shortness of breath (dyspnea), from the Scios unit of Johnson & Johnson (JNJ).

Off-label coverage (May 16, 2005)
CMS draft decision memo seeking public comment on a decision not to draft a national coverage determination for radiolabeled antibodies Zevalin ibritumomab tiuxetan from Biogen Idec (BIIB) and Bexxar tositumomab from GlaxoSmithKline (LSE:GSK; GSK) to treat non-Hodgkin's lymphoma (NHL) (see BioCentury Extra, Monday May 9).

Product Documentation (May 9, 2005)
� Zarnestra: Briefing documents for the May 5 meeting of FDA’s Oncologic Drugs Advisory Committee (ODAC) to review Zarnestra tipifarnib for advanced myeloid leukemia (AML), from Johnson & Johnson (JNJ) (see Cover Story).

Amgen v. Suthers and Niwana (May 2, 2005)
Lawsuit seeking to compel Amgen Inc. (AMGN) to resume supply of glial-derived neurotrophic factor (GDNF) to Parkinson's disease patients.

Product Documentation (May 2, 2005)
� Xigris: Dear Healthcare Professional letter from Eli Lilly & Co. (LLY) for Xigris drotrecogin alfa to treat severe sepsis, announcing the halt of enrollment in a pediatric sepsis trial due to futility. (PDF file)

Product Documentation (PDF file) (April 25, 2005)
� Trileptal: "Dear Healthcare Provider" letter about additional warning on the label for epilepsy drug Trileptal oxcarbazepine, from Novartis AG (NSV; SWX:NOVN) (see BioCentury Extra, Wednesday, April.20).

Phase O trials (PDF file) (April 18, 2005)
FDA draft guidance on exploratory IND studies.

Reimbursement (PDF file) (April 11, 2005)
CMS draft guidance on “coverage with evidence development,” linking national coverage determinations with requirements to collect additional clinical evidence (see “Show CMS the Data,” BioCentury, April 11).

Product Documentation (April 1, 2005)
� Agrylin/Clolar/Diflucan: FDA announces availability of medical and pharmacology reviews of pediatric studies submitted in supplements for Agrylin anagrelide to treat essential thrombocythemia, from Shire Pharmaceuticals Group plc (LSE:SHP; SHPGY); Clolar clofarabine to treat treat children with refractory or relapsed acute lymphocytic leukemia, from Genzyme Corp. (GENZ); and Diflucan fluconazole to treat fungal infections, from Pfizer Inc. (PFE).
� Reminyl: "Dear Healthcare Professional" letter warning of two deaths seen in clinical trials of patients with mild cognitive impairment who were taking Reminyl galantamine, which is approved to treat mild to moderate Alzheimer's disease (AD), from Johnson and Johnson (JNJ) and Shire Pharmaceuticals Group plc (LSE:SHP;SHPGY). (PDF file)

NIH funding (March 28, 2005)
Table of the actual and estimated annual NIH research funding for 2003 through 2006, by disease area.

Lupus (PDF file) (March 28, 2005)
FDA draft guidance for the development of drugs to treat systemic lupus erythematosis.

Product Documentation (March 21, 2005)
� Avonex: Dear Healthcare Professional letter describing rare reports of severe hepatic injury in multiple sclerosis patients receiving Avonex interferon beta-1a, from Biogen Idec Inc. (BIIB) (see BioCentury Extra, Wednesday March 16). (PDF file)
� Xigris: FDA notifies healthcare professionals about revisions to the warnings section of labeling for Xigris drotrecogin alfa a biological to treat adult patients with severe sepsis who are at high risk of death, from Eli Lilly & Co. (LLY).

Insider trading (March 14, 2005)
SEC statement on new allegations of insider trading in shares of ImClone Systems Inc. (IMCL) (see BioCentury Extra, Wednesday, March 9.)

PDUFA (PDF file) (March 14, 2005)
FDA notice of a new web-based system to electronically obtain user fee payment identification numbers and submit PDUFA cover sheets.

Product Documentation (March 14, 2005)
� Baraclude: Briefing documents from the March 11 meeting of FDA's Antiviral Drug Products Advisory Committee to discuss Baraclude entecavir, from Bristol-Myers Squibb Co. (BMY) (see Cover Story).

Biosimilars (PDF file) (March 7, 2005)
Comments submitted by the Biotechnology Industry Organization (BIO) regarding a draft guidelines released by the EMEA last December concerning follow-on biologics (see BioCentury Extra, Friday March 4).

Product Documentation (March 7, 2005)
� Combidex: Briefing documents for the Mar. 3 meeting of FDA's Oncologic Drugs Advisory Committee to discuss Combidex ferumoxtran-10 as an MRI contrast agent to differentiate between metastatic and non-metastatic lymph node, from Advanced Magnetics Inc. (AVM) and Cytogen Corp. (CYTO).
� Iressa: Briefing documents for the Mar. 4 meeting of FDA's Oncologic Drugs Advisory Committee to discuss Iressa gefitinib to treat non-small cell lung cancer in patients who had failed chemotherapy, from AstraZeneca plc (LSE:AZN; AZN) (see BioCentury Extra, Friday March 4). (PDF file)

Cell/Gene therapy (PDF file) (February 28, 2005)
Briefing information for the March 3-4 meeting of FDA’s Cellular, Tissue and Gene Therapies Advisory Committee to discuss cellular therapies for repair and regeneration of joint surfaces.

Genetic nondiscrimination (February 28, 2005)
Summary of the Genetic Information Nondiscrimination Act of 2005, passed by the U.S. Senate.

Lung Cancer (February 28, 2005)
NICE guidance on the diagnosis and treatment of lung cancer.

Microorganisms (PDF file) (February 28, 2005)
FDA draft guidance for manufacturing biological drug substances, intermediates, or products using spore-forming microorganisms.

Stem cells (February 21, 2005)
Citizen's petition filed with California's Independent Citizen's Oversight Committee proposing conflict of interest and ethical regulations for implementation of Proposition 71 (see BioCentury Extra, Thursday Feb. 17).

Clinical trials registries (February 14, 2005)
Newly launched registry of clinical trials, from Forest Laboratories Inc. (FRX).

Drug safety (February 14, 2005)
� Briefing information for the Feb. 16-18 joint meeting of FDA's Arthritis and Drug Safety and Risk Management advisory committees to discuss Cox-2 inhibitors (PDF file).
� Briefing information for the Feb. 14-15 meeting of FDA's Pediatric Advisory Committee to discuss adverse event reporting and potential cancer risk among pediatrics treated with dermatological immunosupressants.

Product Documentation (February 14, 2005)
� Adderall XR: Health Canada statement on its decision to suspend sales of Adderall mixed salts amphetamine to treat attention deficit hyperactivity disorder (ADHD), from Shire Pharmaceuticals Group plc (LSE:SHP; SHPGY).
� Agrylin: Dear Healthcare Professional letter concerning changes to the contraindications and warning sections of the label for Agrylin (Xagrid in the EU) anagrelide to treat essential thrombocythemia, from Shire Pharmaceuticals Group plc (LSE:SHP; SHPGY).

NIH (February 7, 2005)
NIH conflict of interest website, containing Information about the agency’s new regulations barring NIH employees from paid or unpaid work for industry and related entities (see BioCentury Extra, Tuesday Feb. 1).

Reimbursement (January 31, 2005)
CMS decision to reimburse off-label use of Avastin bevacizumab from Genentech Inc. (DNA) and Roche (SWX:ROCZ); Camptosar irinotecan from Pfizer Inc. (PFE); Eloxatin oxaliplatin from sanofi-aventis (Euronext:SAN; SNY); and Erbitux cetuximab from ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb (BMY)) in trials sponsored by the National Cancer Institute.

Product Documentation (January 24, 2005)
� Aranesp: Dear Healthcare Professional letter warning of an increased risk of cardiovascular events and mortality associated with high doses of other epoetin products, which has been added to the label of Aranesp darbepoetin alfa to treat chemotherapy-induced anemia in patients with nonmyeloid malignancies, from Amgen Inc. (AMGN). (PDF file)

COX-2 inhibitors (January 17, 2005)
� Initial agenda for the Feb. 16-18 joint meeting of FDA's Arthritis and Drug Safety and Risk Management advisory committees to discuss risk/benefit considerations for COX-2 drugs and related agents (see Cover Story).

Reimbursement (January 17, 2005)
HHS report describing an intensified CMS-FDA collaboration to speed reimbursement decisions.

Product Documentation (January 17, 2005)
� Mevacor: Briefing information for the Jan. 13-14 joint meeting of FDA's Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee on an over-the-counter marketing application for Mevacor lovastatin, from Merck & Co. Inc. (MRK) (see BioCentury Extra, Friday Jan. 14).

Product Documentation (January 10, 2005)
� Avastin: Dear Healthcare Provider letter regarding an increased risk of arterial thromboembolic events associated with the use of Avastin bevacizumab when used in combination with chemotherapy, from Genentech Inc. (DNA). (PDF file)

Price controls (PDF file) (January 3, 2005)
U.S. Commerce Department report on the impact of pharmaceutical price controls in OECD countires (see BioCentury Extra, Tiuesday Dec. 21, 2004).

Product Documentation (January 3, 2005)
� Plenaxis: CMS decision to reimburse for prostate cancer drug Plenaxis abarelix, from Praecis Pharmaceuticals Inc. (PRCS).
� Remicade: Dear Healthcare Professional letter concerning a new warning for hepatotoxicity for Remicade infliximab, from the Centocor Inc. subsidiary of Johnson & Johnson (JNJ). (PDF file)

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