Pharmaceutical Industry News Archive

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May 2007

May 1

Pfizer Wins Celebrex Patent Decision in Canadian Court, Launch of Generic Product by Novopharm Prohibited until 2014 Astellas and Theravance Announce Submission of Telavancin MAA for the Treatment of Complicated Skin and Soft Tissue Infections in Europe New Hampshire Law Banning Commercial Use of Prescription Information Declared Unconstitutional Ista Pharma Ltd Withdraws Its Marketing Authorisation Application for Vitragan Lilly to Publish Information on Grants and Contributions IMPAX Reports SEC Actions MedImmune Reports Financial Results for 2007 First Quarter Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol FDA Warns Consumers About Counterfeit Drugs From Multiple Internet Sellers Baxter Executives Provide Update on Progress at Annual Shareholder Meeting Inex Pharmaceuticals Announces Completion of Spin-out of Tekmira Pharmaceuticals Corporation Eurand Files IPO Registration Statement with SEC First of Its Kind Data Show: Immediate Treatment of Early MS Patients with Betaseron Significantly Delayed Permanent Disability Physicians Practice Acquired by United Business Media

May 2

Biogen Idec Reports First Quarter 2007 Results Teva Reports First Quarter 2007 Results CollaGenex Pharmaceuticals Provides Update on 40 mg Cohort of Phase II Dose-Finding Study of Incyclinide for the Treatment of Acne FDA Approves Oscient Pharmaceuticals' Factive Tablets for Five-Day Treatment of Community-Acquired Pneumonia FDA Advisory Committee Finds Substantial Evidence to Support Advair 500/50 in Reducing COPD Exacerbations FDA Approves Fragmin as First Low-Molecular-Weight Heparin for Extended Treatment to Reduce the Recurrence of Blood Clots in Patients with Cancer Novo Nordisk: Financial statement for the period 1 January 2007 to 31 March 2007 (2 May 2007) Pfizer Launches Online Initiative Disclosing Its U.S. Post-Marketing Commitments Bristol-Myers Squibb Breaks Ground on New Biologics Manufacturing Facility in Massachusetts FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications Sunesis Pharmaceuticals Announces Preclinical Milestone Payment in BACE Collaboration with Merck Allergan Reports First Quarter Operating Results New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

May 3

Vyvanse (lisdexamfetamine dimesylate) Receives Final DEA Schedule Classification, Clearing Way for Launch of First Prodrug Stimulant for Treatment of ADHD sanofi-aventis: Full-year Guidance Raised on Good 2007 First-Quarter Results Medarex to Receive Milestone Payment from Amgen Statement by Merck & Co., Inc., Regarding the Fracture Intervention Trial with Fosamax (alendronate sodium) and Incidence of Atrial Fibrillation Morgan Keegan To Acquire Shattuck Hammond Partners GPC Biotech Consolidates Drug Discovery Activities Medicis Announces FDA Approval of Perlane Mylan Announces Tentative FDA Approval for Letrozole Tablets, USP GPC Biotech AG (DE) - GPC Biotech Consolidates Drug Discovery Activities Senate Committee on Finance Responds to ACCME Takeda Pharmaceutical First Sponsor In New Healthcare Broadband Platform Former Serono Employee Not Guilty in Health Care Fraud Case

May 4

Dyax Announces the Resignation of Thomas Beck, M.D., President and Chief Operating Officer Rx for Africa, Inc. Announces Merger with Rx Africa (Ethiopia) PLC and Diamond Entertainment Corporation Treatment with Copaxone Plus Minocycline Showed Substantial Reduction of Disease Activity in Patients with Active Relapsing-Remitting Multiple Sclerosis Schering-Plough Receives Request for Additional Information From Federal Trade Commission in Connection With Planned Organon Biosciences N.V. Transaction Pharmaceutical Whistleblowers Tell Their Tales Through Blogs, Congress Responds Merck & Co., Inc. Statement on Brazilian Government's Decision To Issue Compulsory License for Stocrin MarketResearch.com Acquires Thomson Business Intelligence (TBI) Market Research (Profound) Service Devax, Inc. Files Registration Statement for Proposed Initial Public Offering

May 7

FDA Advises Manufacturers to Test Glycerin for Possible Contamination Takara Bio Grants Transgenomic License for LA-PCR Technology Adverse Event of FG-2216 for the Treatment of Anemia Overseas Co-Promotion of Actemra, a Treatment for Rheumatoid Arthritis Official Completion of New Patient Enrollment of Post Marketing Surveillance on Enbrel Shows Encouraging Results for Patients and Physicians CollaGenex Pharmaceuticals Discontinues 40 mg Cohort of Phase II Dose-Finding Study of Incyclinide for the Treatment of Acne Affitech Signs Antibody Research and Licensing Agreement with Roche Peptech and Evogenix Merge to Form Antibody Powerhouse Bayer HealthCare and Intendis Announce Strategic Alliance to Co-Promote Yaz (Drospirenone/Ethinyl Estradiol) for Treatment of Moderate Acne Pfizer Partners with Canadian Policymakers to Continue Shaping an Environment Conducive to Research and Innovation AstraZeneca to Begin Construction for $100M Research Investment at R&D Boston; Expansion Solidifies Company's Commitment to Massachusetts as a Scientific and Biotech Hub Viragen Shifts Development Focus for Anti-Cancer Products USA for Innovation Launches ThaiLies.com

May 8

inVentiv Health Announces Executive Management Changes AARP Welcomes Senate Passage of Rx Importation, but Promises to Fight Unnecessary Importation Roadblocks AARP Welcomes Senate Passage of Rx Importation, but Promises to Fight Unnecessary Importation Roadblocks AEterna Zentaris Regains Exclusive Worldwide (ex-Japan) Rights from Solvay for Cetrorelix in Endometriosis Indication AEterna Zentaris Regains Exclusive Worldwide (ex-Japan) Rights from Solvay for Cetrorelix in Endometriosis Indication Solvay Group First Quarter 2007 Results CEOS Up $1.26 Billion, Shareholders Down $330 Billion Bayer Publishes Interim Report for the First Quarter of 2007 Bradley Pharmaceuticals Announces Resignation of Dr. Leonard S. Jacob as Non- Executive Chair, Appointment of Seth W. Hamot as Interim Non-Executive Chair Medicis Pharmaceutical to Pay U.S. $9.8 Million to Resolve False Claims Allegations Lupin Announces Final FDA Approval of Cefdinir for Oral Suspension, 250 mg/5 mL, Launches Entire Product Family Singapore Attracts Four Major Biologics Manufacturing Investments Totaling Close to US$1 Billion in Less Than Two Years

May 14

Teva Comments About the Acquisition of Merck KGaA Generic Business Mylan Laboratories to Acquire Generics Business of Merck KGaA Eisai Obtains Favorable Ruling in Aciphex Patent Infringement Lawsuit Against Teva Pharmaceuticals and Dr. Reddy's Laboratories Cardinal Health to Acquire Medical Technology Leader VIASYS Healthcare for $1.5 Billion Southern District Court of New York Rules Patent for Aciphex Enforceable Biovail Acknowledges Receipt of Wells Notice Oral Pleadings in Implanon Appeal Recall of Two Valproic Acid Drugs, Depakene 500 mg and Ratio-Valproic 500 mg Critical Therapeutics' Sales Force Gains Access to a Second Product as FDA Approves Co-Promotion Partner's New Treatment for COPD Bayhill Therapeutics Appoints Fred Kurland as Chief Financial Officer P&G Announces Business Unit Realignment

May 21

KineMed Evaluates the Mechanism of Action for Colesevelam in Patients With Type 2 Diabetes Talabostat Clinical Program Put on Clinical Hold by FDA AMRI Acquires Manufacturing Facilities in India Tibolone Study in Breast Cancer Patients to Close Ahead of Schedule Roche Receives Approvable Letter for Mircera in the United States Pfizer Says Research and Development Head John LaMattina Will Retire This Year Elan and Wyeth to Initiate Phase 3 Clinical Trial of Bapineuzumab (AAB-001) in Alzheimer's Disease Novartis Defends Its Intellectual Property Rights as US Court Issues Order Prohibiting Teva from Selling a Generic Version of Lotrel Questcor Announces Departure of CEO James Fares Champions Biotechnology, Inc. Acquires Biomerk, Inc. Thermo Fisher Scientific and Quintiles Create Joint Venture to Provide Integrated Response Technology Services GlaxoSmithKline Responds to NEJM Article on Avandia FDA Issues Safety Alert on Avandia

May 24

Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine CV Therapeutics Significantly Reduces Operating Expenses Mylan Reports Fourth Quarter & Fiscal 2007 Adjusted Diluted EPS of $0.47 & $1.65 Excluding any Contribution from Amlodipine EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim) STARLIMS Technologies Ltd. Announces Public Offering of Its Ordinary Shares in the United States at a Price Per Share of $13.50 with Net Proceeds to the Company of Approximately $25.5 Million Neose Receives Milestone Payment From Novo Nordisk on Factor IX Program Annual Stockholders’ Meeting of Bayer Schering Pharma AG, Berlin, Germany: Integration of Bayer Schering Pharma Progressing Rapidly GlaxoSmithKline Launches Chinese R&D Centre with Appointment of Head in Shanghai Helicos Biosciences Prices Initial Public Offering Hispanics and African Americans Among Those at Risk Due to High Cost of Prescription Drugs FDA Sends Warning Letter to Enzon Over Abelcet Flash Card

May 31

Bristol-Myers Squibb Pleads Guilty to Lying to the Federal Government About Deal Involving Blood-Thinning Drug FDA Sends Warning Letter to Allergan Regarding Acular Advertisement Medarex Announces Collaborative Research Agreement with Mitsubishi Pharma Point Therapeutics Reduces Costs by Cutting Work Force Philadelphia Hormone Therapy Verdict Overturned in Favor of Wyeth inVentiv Health Acquires Addison Whitney, Full Service Global Brand Identity and Consulting Firm AtheroGenics Announces Business Plan to Focus on Advancing AGI-1067 in Diabetes Point Therapeutics Reduces Costs by Cutting Work Force Swissmedic Orders the Withdrawal of Zelmac for Irritable Bowel Syndrome KFDunn Merges with Aloysius Butler & Clark to Form New Division: KFDunn Life Sciences Marketing Communications Advanced Cell Technology Enters Into Letter of Intent to Acquire Mytogen, Inc. and Proceed with the Human Clinical Trials Utilizing Myoblasts for the Treatment of Heart Failure Third Point Asks Unconflicted Directors of PDL BioPharma to Conclude Investigation Into CEO McDade's Suspected Ethical and Business Breaches as Expeditiously as Possible FDA Finalizes Guidances For Pandemic and Seasonal Influenza Vaccines HealthShares Announces Changes to the HealthShares Infectious Disease, Respiratory/Pulmonary, Cancer, and Composite Indexes
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