Pharmaceutical Industry News Archive
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February 2009
February 2
Pfizer Discontinues Global Phase III Trial of Axitinib for Futility in Advanced Pancreatic Cancer
Aastrom Phase II IMPACT-DCM Trial Placed On Clinical Hold Pending Review of Isolated Serious Adverse Event
Federal Trade Commission Files Complaint Against Par Pharmaceutical Over Court-Approved AndroGel Litigation Settlement
Hollis-Eden Pharmaceuticals Announces Cost-Cutting Measures to Focus Resources on Advancement of Ongoing Clinical Development Programs
February 3
Schering-Plough Reports Financial Results for 2008 Fourth Quarter, Full Year
Merck Announces Fourth-Quarter and Full-Year 2008 Financial Results
King Pharmaceuticals Announces Corporate Restructuring to Reduce Operating Expenses
PharmaNet Development Group Agrees to be Acquired by JLL Partners
Astellas Announces Global Development Organizational Changes
February 4
Allergan Reports Fourth Quarter 2008 Operating Results and Announces Restructuring
Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated])
What's the ideal relationship between the drug industry, health professionals and patients?
Sens. Kohl, Grassley Introduce Bill to Stop Industry 'Payoffs' That Delay Generic Drugs
University of Maryland School of Medicine and Medical Center Implement New Policies Governing Physician/Industry Relationships
Strong operating results for Roche in 2008
February 5
February 6
Vertex Pharmaceuticals Announces Transition in Company Leadership
Idenix Pharmaceuticals and GlaxoSmithKline Sign Worldwide License Agreement for IDX899 for HIV
Biogen Idec Reports Full Year and Fourth Quarter 2008 Results
Biogen Idec Receives Shareholder Proposal
Avigen Board Rejects BVF Offer as Inadequate
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega
Abbott Acquisition of Advanced Medical Optics Clears U.S. Antitrust Review
Future Pharmaceutical Innovation Requires Patients to be Placed Right at the Centre
Schering Plough Invests $30 Million in Scottish Facility
Taro Receives FDA Warning Letter Following Inspection of Its Canadian Manufacturing Facility
Sudler & Hennessey Expands Montreal Presence
February 9
H. Lundbeck A/S (DK) - Lundbeck to acquire US-based Ovation Pharmaceuticals, Inc.
KV Pharmaceutical Company Reduces Workforce
Dynavax Announces Receipt of Communication from the U.S. FDA on HEPLISAV Hepatitis B Vaccine
GTCR Announces Agreement to Sell Ovation Pharmaceuticals
Mass. AG Martha Coakley Enters Agreement with Bayer Corporation Resolving Allegations of Deceptive Advertising of Oral Contraceptive
February 10
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs
Pfizer to Publicly Disclose Payments to U.S. Physicians, Healthcare Professionals and Clinical Investigators
Genentech Urges Shareholders to Take No Action With Respect to Unsolicited Tender Offer From Roche
Roche Commences Tender Offer for Genentech for US$86.50 Per Share in Cash
New Guidelines for Prescribing Opioid Pain Drugs Published
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs
Enzon Discontinues Further Development of rhMBL
SK&A Study: More Docs Limit Sales Rep Access
Significant Shareholder Calls upon Enzon to Immediately Add Two Candidates to the Board of Directors
February 11
FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events
FDA Issues Complete Response Letter for Risperdal Consta for the Adjunctive Maintenance Treatment of Bipolar Disorder
FDA and Kaplan EduNeering expand alliance
Sanofi-aventis Delivers 2008 Results Above Guidance
Strong Fourth Quarter for Genzyme Concludes Productive Year
Bristol-Myers Squibb Statement on Mead Johnson Nutrition Company IPO
February 12
Bayer Schering Pharma to Invest 100 Million Euro in China to Build a Global R&D Center
Merck & Co., Inc. Acquires Biologic Manufacturing Capabilities and Developmental Follow-on Biologics Portfolio from Insmed
Pharmalive.com Launches Medical Device Industry Report
Portola Pharmaceuticals Enters Worldwide License Agreement for Development and Commercialization of Novel Antiplatelet Drug Elinogrel
Telik Implements Reorganization to Focus Resources Toward Drug Development Pipeline
Oscient Pharmaceuticals Restructures Commercial Organization
February 13
Sandoz Receives European Commission Approval For Biosimilar Filgrastim
Haemacure Restructures - Seeks Financing or Sale of the Company
Clinicians Using Electronic Prescribing Override Most Medication Safety Alerts
Spending for Prescription Pain Medicines Has Tripled in 10 Years
Novogen to Focus on Oncology Program
ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients
February 17
FDA Approves ULORIC (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
Hospira Reports Fourth-Quarter and Full-Year 2008 Results
Teva Reports Record Full Year 2008 and Fourth Quarter Results
Synta Earns $10 Million from GlaxoSmithKline for Achieving Elesclomol Milestone
Merck Sharp & Dohme Ltd Withdraws Its Marketing Authorisation Application For Vorinostat MSD (Vorinostat)
Doctors' Resources for Off-Label Prescribing May Be Incomplete, Unclear
Teva Provides 2009 Financial Outlook
February 18
CSL Limited announce Half-Year Results for 2008/09
Merck KGaA: 2008 Operating Result Rises 16% to € 1,131 Million
Type of Rheumatoid Arthritis Medication May be Associated With Increased Risk for Shingles
GPC Biotech and Agennix Announce Proposed Merger
Cipher receives tentative FDA approval for extended-release tramadol capsules
Jury Finds Pharmacia Committed Fraud On Wisconsin Medicaid Program; Van Hollen’s Department Of Justice Wins State $9 Million
February 19
Shire Delivers Excellent Growth for the Year, with the New Product Portfolio Achieving Sales of $1 Billion
Solvay: 2008 Operating Result (EUR 965 Million) Down By 19% Compared To The Record Result of 2007
Sanofi-Aventis U.S. Launches Diabetes-Focused YouTube Channel
European Commisssion Grants Ferring Pharmaceuticals Approval of Firmagon (Degarelix) for Treatment of Prostate Cancer
European Medicines Agency Recommends Suspension of Marketing Authorization for Raptiva
FDA Public Health Advisory: Updated Safety Information about Raptiva (efalizumab)
United States Joins Suits Against Scios and Johnson & Johnson
European Medicines Agency recommends continued vaccination with Gardasil
European Medicines Agency recommends new contraindication and warning for Rasilez and other aliskiren medicines
Dallas Scientists Discover Statins May Falsely Indicate Thyroid Problems
La Jolla Pharmaceutical Company Announces Reduction in Workforce and Evaluates Strategic Options
February 20
CV Therapeutics Reports 2008 Fourth Quarter and Full Year Financial Results
CV Therapeutics' Board of Directors Rejects Astellas Unsolicited Proposal
Schering-Plough Submits Response to FDA for SAPHRIS (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
UCB (BE) - UCB to Divest Equasym
Shire to Enter European ADHD Market With the Acquisition of Equasym IR and XL
Questions of Ethics and Quality Cloud Globalization of Clinical Trials
House Committee on Energy and Commerce Chairmen Waxman and Stupak Request Study Data for Vytorin
Daiichi Sankyo Notice on Organizational Restructuring as of April 1, 2009
Discontinuation of Development of TAK-242 for Severe Sepsis
Shire Announces Opening of Office in Japan
Neuralstem's ALS Trial on Clinical Hold
February 23
Abbott Receives European Commission Clearance on Acquisition of Advanced Medical Optics
Astellas Pharma Issues Statement Regarding CV Therapeutics Rejection of All-Cash Proposal
European Commission Approves EFIENT (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI
AstraZeneca Announces SEROQUEL XR is Now Available to Treat Bipolar Depression
Patient Knowledge of Health Information Influences Cancer Treatment
Two FDA Quality Systems Compliance Resources Published
MedWatch - Zonisamide (marketed as Zonegran, and generics) Can Cause Metabolic Acidosis in Some Patients
February 24
Genentech Announces March 2, 2009 Webcast of Investment Community Meeting
Genentech Special Committee Rejects Roche's $86.50 Offer as Inadequate
Panacos Provides Corporate and Strategic Update
AstraZeneca's Partner, MAP Pharmaceuticals, Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints
Basilea Pharmaceutica Ltd. (CH) - Basilea Pharmaceutica Files Claims Against Johnson & Johnson Over Its Handling of Ceftobiprole (ZEFTERA/Zevtera) Clinical Studies
Basilea Pharmaceutica Ltd. (CH) - Zevtera Review Process Delayed in EU
Orion Corporation (FI) - Orion: Primary Objective of STRIDE-PD Study Was Not Achieved
Pfizer Discontinues Development of Two Phase 3 Compounds
US Physicians Sharply Increase Their Negative Word of Mouth about Pharma, with EU Doctors Also Expressing High Dissatisfaction
February 25
Elan Announces Further Alignment of Resources as Part of On-Going Strategic Review Process
Abbott Successfully Completes Tender Offer for Shares of Advanced Medical Optics
Smaller, Refocused Salesforce Will Enable Pharmaceutical Companies to Create Greater Value for Patients, Says New PricewaterhouseCoopers Report
Press Statement Issued by Ranbaxy Laboratories Limited
United States Files Complaint Against Forest Laboratories for Allegedly Violating the False Claims Act
Trubion Pharmaceuticals Inc. Announces Work-Force Reductions and Restructuring
February 26
FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India
Forest Laboratories, Inc. Provides Statement in Response to Complaint Filed by U.S. Government
King Pharmaceuticals Reports Year-End and Fourth-Quarter 2008 Financial Results
Parents Learn About HPV Vaccine Mostly from Drug Company Ads
February 27
Endo Pharmaceuticals Returns Product Rights to Transdur-Sufentanil to Durect
FDA Sends Letter to GlaxoSmithKline Over Avodart Ad
Synta Suspends Elesclomol SYMMETRYTrial in Metastatic Melanoma
FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs
Amicus Therapeutics Suspends Enrollment for Phase 2 Clinical Trial of AT2220 for Pompe Disease
Astellas Files Lawsuit Against CV Therapeutics
