Pharma Industry News Archive

Pharma Industry News: August 2009

August 3 Repros Therapeutics Inc. Suspends Dosing of Proellex and Provides Update on Financial Status
August 3 U.S. District Court Issues in Favor of Daiichi Sankyo Regarding Patent Litigation for Benicar, Benicar HCT and Azor
August 3 Nycomed to Acquire Local Portfolio from Sanofi-Aventis and Zentiva
August 3 European Medicines Agency and U.S. Food and Drug Administration (FDA) launch Good Clinical Practice Initiative
August 4 MedWatch - Botox and Botox Cosmetic and Myobloc:changes to drug names to reinforce individual potencies and prevent medication errors, recommendations for healthcare professionals to consider, information for patients, family members
August 4 Antidepressant Use Increasing In the United States
August 4 Lilly, Chao Center, PDA partner with Russian officials to improve quality of global drug manufacturing, distribution
August 4 Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers
August 4 MedWatch - Tumor Necrosis Factor (TNF) Blockers: Boxed Warning describing increased risk of lymphoma in children, adolescents treated with TNF blockers
August 5 Anesiva, Inc. and Arcion Therapeutics Announce Merger Agreement
August 5 Dynavax Announces Path for HEPLISAV Hepatitis B Vaccine Development
August 5 Merck and Schering-Plough Resolve Previously Disclosed Civil Class Action Lawsuits Related to Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe)
August 5 Shire plc: Core Portfolio of Products Delivers 20% Sales Growth
August 5 FDA: Cancer Warnings Required for TNF Blockers
August 5 Withdrawal Of The Marketing Authorisation In The European Union
August 5 The Foundation for National Institutes of Health Announces Unprecedented Product Donation by sanofi-aventis in the U.S.
August 5 Teva Announces Appeals Court Ruling Affirming Invalidation of Yasmin Patent
August 6 King Pharmaceuticals Reports Second Quarter 2009 Financial Results
August 6 Med Ad News? PharmaMed Marketing & Media Conference Announces Updates to the Three Innovative Sales-Force-Effectiveness, Digital Marketing & Patient Centered Communication Tracks
August 6 NicOx reacquires rights to PF-03187207 for glaucoma from Pfizer
August 6 Pharmaceutical & Medical Packaging News Launches New Website Featuring Breaking News & More Industry Resources For Healthcare Packaging Professionals
August 6 U.S. Payers Intend to Limit Preferred Coverage to Only One Immune Biologic
August 6 Baxter Completes Production of First Commercial Batches of A/H1N1 Pandemic Vaccine
August 6 Elan Files Declaratory Suit Against Biogen Idec; Company Has Not Breached Tysabri Collaboration Agreement
August 6 Vernalis and GlaxoSmithKline Enter Into a Collaboration, Option and License Agreement Over a Novel Vernalis Oncology Programme
August 7 Active Biotech (SE) - New information regarding RhuDex
August 7 Antisoma plc (UK) - Antisoma Announces Discontinuation of Development of AS1402
August 7 FDA Commissioner Sets Out Vision on Enforcement to Support Public Health
August 7 FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination
August 7 Merck Shareholders Approve Merger With Schering-Plough
August 7 Nabi Biopharmaceuticals Announces Sale of PentaStaph to GlaxoSmithKline PLC
August 7 Alzheimer's Drug Discovery Foundation-Funded PharmatrophiX Reaches Major Milestone
August 10 Nycomed and Forest Laboratories to Collaborate on Daxas (roflumilast) for COPD
August 11 Astellas Seeks Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications
August 11 Novartis International AG (CH) - Sandoz Launches First Generic Version of Prograf Capsules
August 11 Statement on Fosamax (alendronate sodium) Product Liability Trial in U.S. District Court
August 12 Schering-Plough Announces Resolution of Litigations on U.S. Marketing of Generic Forms of Solid Oral Dosage Forms of Clarinex
August 12 Dwayne Johnson, Novo Nordisk and the Entertainment Industry Foundation Educate Families about Healthy Living and Diabetes
August 12 Bristol-Myers Squibb Announces Expiration of Hart-Scott-Rodino Review Period for Acquisition of Medarex, Inc.
August 13 FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
August 13 Stada Chief Financial Officer departs
August 13 STADA with development as planned in H1/2009: Sales: EUR 755.2 million, net income EUR 48.3 million ? outlook confirmed
August 13 Update on Astellas' Complaint Challenging the FDA's Decision for Citizen Petition in the US
August 13 Mylan Pharmaceuticals Receives Final FDA Report and Reaffirms Its 48-Year Exemplary Record of Quality
August 14 Supply Shortage Of Cerezyme ? Updated Treatment Recommendations Required
August 14 NEHI Research Shows Patient Medication Nonadherence Costs Health Care System $290 Billion Annually
August 14 FDA MedWatch - CellCept (mycophenolate mofetil) - cases of Pure Red Cell Aplasia reported in patients treated with CellCept
August 17 Gilead Sciences Receives Subpoena from U.S. Department of Health & Human Services Regarding Ranexa
August 18 U.S. District Court Rules Against Lilly Regarding Gemzar Patent
August 18 Geron's IND for Spinal Cord Injury Placed on Hold
August 18 Transcept Announces Plans to Reduce Expenses by Decreasing Staff Following Recent Completion of Purdue U.S. License and Collaboration Agreement
August 18 Par Pharmaceutical Wins on Invalidity in Ultram ER Litigation
August 19 Basilea Pharmaceutica Ltd. (CH) - FDA Issues Warning Letter to Johnson & Johnson Related to Ceftobiprole
August 19 FDA Sends J&J Warning Letter Over Trial Conditions
August 19 PhRMA Statement on Commitment to Health Care Reform
August 19 Mylan Files Lawsuit Against Pittsburgh Post-Gazette
August 19 Merck Wins Singulair Patent Infringement Lawsuit
August 19 Pfizer And Private Access Announce Plans To Develop Online Community To Accelerate Clinical Research
August 19 US Physicians Define Healthcare Reform Platform on Sermo
August 20 ZymoGenetics Submits Citizen Petition to FDA Requesting Removal of Bovine Thrombin from Market in the Interest of Patient Safety
August 20 Secure eHealth License Holder Private Access, Inc. Announces Commercial Beta Release of Privacy-Enhanced Search Technology, Including Collaboration with Pfizer, Inc.
August 20 Bristol-Myers Squibb Announces Preliminary Court Approval of Derivative Settlement
August 21 FDA Proposes Mandatory Electronic Safety Reporting
August 21 Bristol-Myers Squibb Extends Tender Offer for Medarex, Inc.
August 21 Merck is Pleased the FDA and CDC Re-Affirm the Safety Profile of Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]
August 21 MediciNova and Avigen Enter Into Definitive Agreement for Business Combination
August 21 Off-label use: Oft not evidence based
August 21 Astellas: Reorganization of Drug Discovery Research Functions
August 21 Palio Announces Partnership with Zemoga
August 21 Diabetes drug linked to increased risk of heart failure
August 24 FDA Issues Warning Letters to Several, Including Allergan, Galderma Laboratories and Johnson & Johnson Pharmaceutical Research & Development
August 24 UCB Further Strengthens its Second Largest Market, Germany
August 24 Shire Builds Competitive Position of its HGT Business through Research Collaboration with Santaris Pharma A/S on LNA Drug Platform
August 24 ARIAD And Its Co-Plaintiffs Announce That the Court of Appeals Granted Their Petition for Rehearing En Banc In the Lilly NF-kB Patent Lawsuit
August 24 Warner Chilcott Acquires P&G's Global Pharmaceuticals Business
August 25 FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat
August 25 Ligand to Acquire Neurogen for Stock and Contingent Value Rights
August 25 GSK Advisory: Warehouse Theft
August 25 MedWatch - Orlistat (marketed as Alli and Xenical): FDA reviewing reports of serious liver injury, including liver failure
August 25 Cambrex Receives FDA Warning Letter
August 25 Study: 3 out of 4 U.S. Nurses Recommend Health Websites to Patients
August 25 Wyeth Continues Research Project Originally Initiated In Collaboration With Karo Bio
August 25 Lawsuit Claims Celgene Corporation Misappropriated the Idea Behind its Multiple Myeloma Treatments
August 26 GlaxoSmithKline Statement Confirming alli Safety
August 27 FDA Warns About Stolen Insulin
August 27 FDA Sends Johnson & Johnson and Pedinol Pharmacal Warning Letters
August 27 Geron Comments on FDA Hold on Spinal Cord Injury Trial
August 27 Abbott to Collaborate With Pfizer Inc on Companion Diagnostic Test to Select Patient Candidates for Novel Investigational Non-Small Cell Lung Cancer Therapy
August 27 WPP Interim Results 2009
August 27 Filing: Ortho-McNeil Drops Injectable Risperdone Development.
August 27 Pfizer and Astellas Announce Co-promotion Agreement for Caduet Combination Tablets
August 27 Taisho Pharmaceutical: Discontinuation of Development of NT-702 for a Part of Indications
August 27 Bristol-Myers Squibb Completes Initial Tender Offer for Medarex, Inc. with 87.7% of Shares Tendered; Announces Subsequent Offering Period
August 27 Pharmalive.Com Launches New Bioscience Investment Report
August 28 MedWatch - Intelence (etravirine):Reports of severe, potentially life-threatening and fatal skin reactions
August 31 Jim New Steps Down as CEO of LifeCycle Pharma Today
August 31 Merck CEO Announces Structure and Global Leadership Team for New Merck

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