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August 2009
August 3
Repros Therapeutics Inc. Suspends Dosing of Proellex and Provides Update on Financial Status
U.S. District Court Issues in Favor of Daiichi Sankyo Regarding Patent Litigation for Benicar, Benicar HCT and Azor
Nycomed to Acquire Local Portfolio from Sanofi-Aventis and Zentiva
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
Antidepressant Use Increasing In the United States
Lilly, Chao Center, PDA partner with Russian officials to improve quality of global drug manufacturing, distribution
Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers
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
Dynavax Announces Path for HEPLISAV Hepatitis B Vaccine Development
Merck and Schering-Plough Resolve Previously Disclosed Civil Class Action Lawsuits Related to Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe)
Shire plc: Core Portfolio of Products Delivers 20% Sales Growth
FDA: Cancer Warnings Required for TNF Blockers
Withdrawal Of The Marketing Authorisation In The European Union
The Foundation for National Institutes of Health Announces Unprecedented Product Donation by sanofi-aventis in the U.S.
Teva Announces Appeals Court Ruling Affirming Invalidation of Yasmin Patent
August 6
King Pharmaceuticals Reports Second Quarter 2009 Financial Results
Med Ad News? PharmaMed Marketing & Media Conference Announces Updates to the Three Innovative Sales-Force-Effectiveness, Digital Marketing & Patient Centered Communication Tracks
NicOx reacquires rights to PF-03187207 for glaucoma from Pfizer
Pharmaceutical & Medical Packaging News Launches New Website Featuring Breaking News & More Industry Resources For Healthcare Packaging Professionals
U.S. Payers Intend to Limit Preferred Coverage to Only One Immune Biologic
Baxter Completes Production of First Commercial Batches of A/H1N1 Pandemic Vaccine
Elan Files Declaratory Suit Against Biogen Idec; Company Has Not Breached Tysabri Collaboration Agreement
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
Antisoma plc (UK) - Antisoma Announces Discontinuation of Development of AS1402
FDA Commissioner Sets Out Vision on Enforcement to Support Public Health
FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination
Merck Shareholders Approve Merger With Schering-Plough
Nabi Biopharmaceuticals Announces Sale of PentaStaph to GlaxoSmithKline PLC
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
Novartis International AG (CH) - Sandoz Launches First Generic Version of Prograf Capsules
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
Dwayne Johnson, Novo Nordisk and the Entertainment Industry Foundation Educate Families about Healthy Living and Diabetes
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
Stada Chief Financial Officer departs
STADA with development as planned in H1/2009: Sales: EUR 755.2 million, net income EUR 48.3 million ? outlook confirmed
Update on Astellas' Complaint Challenging the FDA's Decision for Citizen Petition in the US
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
NEHI Research Shows Patient Medication Nonadherence Costs Health Care System $290 Billion Annually
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
Geron's IND for Spinal Cord Injury Placed on Hold
Transcept Announces Plans to Reduce Expenses by Decreasing Staff Following Recent Completion of Purdue U.S. License and Collaboration Agreement
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
FDA Sends J&J Warning Letter Over Trial Conditions
PhRMA Statement on Commitment to Health Care Reform
Mylan Files Lawsuit Against Pittsburgh Post-Gazette
Merck Wins Singulair Patent Infringement Lawsuit
Pfizer And Private Access Announce Plans To Develop Online Community To Accelerate Clinical Research
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
Secure eHealth License Holder Private Access, Inc. Announces Commercial Beta Release of Privacy-Enhanced Search Technology, Including Collaboration with Pfizer, Inc.
Bristol-Myers Squibb Announces Preliminary Court Approval of Derivative Settlement
August 21
FDA Proposes Mandatory Electronic Safety Reporting
Bristol-Myers Squibb Extends Tender Offer for Medarex, Inc.
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]
MediciNova and Avigen Enter Into Definitive Agreement for Business Combination
Off-label use: Oft not evidence based
Astellas: Reorganization of Drug Discovery Research Functions
Palio Announces Partnership with Zemoga
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
UCB Further Strengthens its Second Largest Market, Germany
Shire Builds Competitive Position of its HGT Business through Research Collaboration with Santaris Pharma A/S on LNA Drug Platform
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
Warner Chilcott Acquires P&G's Global Pharmaceuticals Business
August 25
FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat
Ligand to Acquire Neurogen for Stock and Contingent Value Rights
GSK Advisory: Warehouse Theft
MedWatch - Orlistat (marketed as Alli and Xenical): FDA reviewing reports of serious liver injury, including liver failure
Cambrex Receives FDA Warning Letter
Study: 3 out of 4 U.S. Nurses Recommend Health Websites to Patients
Wyeth Continues Research Project Originally Initiated In Collaboration With Karo Bio
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
FDA Sends Johnson & Johnson and Pedinol Pharmacal Warning Letters
Geron Comments on FDA Hold on Spinal Cord Injury Trial
Abbott to Collaborate With Pfizer Inc on Companion Diagnostic Test to Select Patient Candidates for Novel Investigational Non-Small Cell Lung Cancer Therapy
WPP Interim Results 2009
Filing: Ortho-McNeil Drops Injectable Risperdone Development.
Pfizer and Astellas Announce Co-promotion Agreement for Caduet Combination Tablets
Taisho Pharmaceutical: Discontinuation of Development of NT-702 for a Part of Indications
Bristol-Myers Squibb Completes Initial Tender Offer for Medarex, Inc. with 87.7% of Shares Tendered; Announces Subsequent Offering Period
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
Merck CEO Announces Structure and Global Leadership Team for New Merck
Pharmaceutical Industry News Archive
2012
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