Pharmaceutical Industry News Archive

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November 2007

November 1

Neurocrine Biosciences and Dainippon Sumitomo Pharma (DSP) Announce Agreement to Develop and Commercialize Indiplon in Japan AstraZeneca PLC: Third Quarter and Nine Months Results 2007 Crestor ANDA FDA Sends Northeast General Pharmaceutical Factory Warning Letter IMS Health Predicts 5 to 6 Percent Growth for Global Pharmaceutical Market in 2008, According to Annual Forecast Further Upgrade to 2007 Financial Guidance Based on Strong Revenue Growth; Vyvanse Demand on Track Dynavax and Merck & Co., Inc. Announce Partnership to Develop Heplisav, an Investigational Hepatitis B Vaccine Currently in Phase 3 Perrigo Announces that Dexcel's Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval All-State Properties, L.P. Announces Termination of Reverse Merger With Chinese Pharmaceutical Company FDA Says Consumers Continue to Buy Risky Drugs Online Averion International Corp. Acquires Hesperion AG Federal Court Ruling Enjoining PTO Rules is a Sound Decision, Says BIO

November 5

FDA Requests Marketing Suspension of Trasylol Bayer Temporarily Suspends Global Trasylol Marketing Transition Therapeutics Provides Update on Diabetes Program AstraZeneca Response to November 2, 2007 Ruling In Re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, U.S. District Court, District of Massachusetts Schering-Plough CEO Calls for Four-Pronged Approach to Improving Current Health Care Environment FDA Requests Marketing Suspension of Trasylol Bayer Temporarily Suspends Global Trasylol Marketing Manipal AcuNova and ECRON Merge to Form ECRON AcuNova Targacept to Receive $2 Million from AstraZeneca for Option to Lead Product Candidate in Alpha7 NNR Program Novacea Halts ASCENT-2 Trial in Advanced Prostate Cancer GlaxoSmithKline Initiates Trials of Promacta/revolade (eltrombopag) to Investigate the Potential to Aid Hepatitis C Patients in Achieving Sustained Virological Response Takeda's Investigational Compound TAK-442 for Treatment of Venous/Arterial Thromboembolism Enters into Phase 2 Clinical Stage in the U.S. and Europe Hagens Berman Sobol Shapiro: Judge Orders Double Damages, Issues Stinging Rebuke in Average Wholesale Price Case FDA Selects Members for Risk Communication Advisory Committee CELSION Provides Update on Status of Special Protocol Assessment (SPA) Submission

November 6

GTx, Inc. and Merck & Co., Inc. Enter Global Strategic Collaboration for the Development of SARMs, a Novel Investigational Class of Drugs to Treat Muscle Loss and other Musculoskeletal Conditions Schering-Plough Reports U.S. District Court for District of Massachusetts Finds No Liability for Subsidiary in AWP Case New Galvus Clinical Data Reinforces Efficacy Profile; Safety Update Provided to Regulatory Agencies Bayer Expects a Record Year in 2007 EPIX Pharmaceuticals Achieves Milestone For Second Discovery Program in Collaboration with GlaxoSmithKline AstraZeneca Announces Nexium(esomeprazole magnesium) Savings Program for Purple Plus Members Allergan Reports Third Quarter Operating Results Remicade Becomes First Anti-TNF Biologic Therapy to Treat One Million Patients Worldwide VWR International, LLC Acquires Netherlands-Based Omnilabo International B.V. BIOBASE Enters into a Custom Curation Service Agreement with Procter & Gamble Court Throws Out Claim in Johnson & Johnson Lawsuit Against the American Red Cross Avandia Withdrawals Increase and Accelerate after Reports of Potential Cardiovascular Risk, According to TNS Healthcare

November 8

Prometheus to Acquire Lotronex From GlaxoSmithKline ADVENTRX Pharmaceuticals Reports Third Quarter 2007 Financial Results Abraxis BioScience Announces the Closing Date for the Separation of Its Proprietary Business from Its Hospital-Based Business Astellas and Boehringer Ingelheim Reach Settlement Agreement with Ranbaxy on Flomax Patent Case Ranbaxy and Astellas/Boehringer Ingelheim Enter Into an Agreement to Resolve Tamsulosin U.S. Patent Litigation Amgen to Provide New Evidence as Part of a Formal Reconsideration of CMS' National Coverage Determination on ESAs FDA Sends Scios Letter for Natrecor Amgen Announces Updates to the U.S. Prescribing Information for ESAs Amicus Therapeutics and Shire plc Enter Into $440 Million ex-US Licensing Agreement to Develop and Commercialize Amigal, Plicera and At2220 Dyax Corp. Announces Extension of Antibody Library Collaboration with ImClone Systems Ortho Biotech to Submit Official Request for Reconsideration to CMS Regarding ESA Coverage Policy

November 14

Merck Serono Exercises Option to Rigel's R763/AS703569 and Aurora Kinase Inhibitors in the Japanese Territory Roche Confirms Commencement of Due Diligence with Ventana Nastech Pharmaceutical Company Initiates Plan for Corporate Restructuring and Will Concentrate on Phase 2 Clinical Programs STEP Study Volunteers to be Informed Whether They Received Vaccine or Placebo Fluorotechnics Expands Global Capability via Acquisition of ETC Elektrophorese-Technik NeoStem, Inc. Acquires Stem Cell Technologies, Inc. from UTEK Corporation Early Communication About an Ongoing Safety Review Cefepime (marketed as Maxipime) Number of Cases of Most Vaccine-Preventable Diseases in U.S. at All-Time Low GSK Revises US Labeling for Avandia FDA Issues an Information for Healthcare Professionals Sheet for Viagra, Levitra, and Cialis

November 27

Sepracor Inc. Announces Completion of SEC Investigation Pharmacopeia and GlaxoSmithKline Collaboration Identifies Two Additional Lead Compounds Taconic Acquires 80% Stake in Artemis FDA Sends Warning Letter to GlaxoSmithKline Over 'Dear Healthcare Practitioner' Letters ImmunoCellular Therapeutics Agrees to Acquire Molecular Antibody Technology Drugs May Not Delay Onset of Dementia U.S. Department of Health and Human Services Completes Funding of 2006 Contract Award to CSC's DVC and Baxter Singulex Teams With Wyeth Pharmaceuticals to Translate Pre-Clinical Biomarker Research Into Clinical Study Design Maxygen Announces Plans to Consolidate Operations in the U.S. Myfortic (mycophenolic acid) Delayed- Release Tablets - Use of Drug During Pregnancy Associated with Increased Risks of Pregnancy Loss and Congenital Malformations

November 29

Exelixis to Receive Milestone Payment From Bristol-Myers Squibb for Achievement of Liver X Receptor Agonist Development Milestone OPKO Health Completes Acquisition of Ophthalmic Technologies, Inc. ChemGenex Announces Shareholder Approval to Demerge Verva Pharmaceuticals New LJS Study Finds Broad Consumer Acceptance of Behind-The-Counter Drugs Regeneron Initiates Major Global Collaboration with Sanofi-aventis to Develop and Commercialize Fully-Human Therapeutic Antibodies Bavarian Nordic A/S Reports Positive Data from First EUA Enabling Study with Imvamune Smallpox Vaccine Diabetes Patients Withdrawn from Avandia Are Most Likely Switched to the New First-in-class Agents, Januvia or Byetta, According to Tns Healthcare MGI PHARMA Issues Statement GSK Statement on US Food and Drug Administration Pediatric Advisory Committee Recommendations Regarding Salmeterol Kyowa Hakko Interim Operating Income up 25.2% Axcan Pharma Inc. to be Acquired by TPG Capital and Affiliates for US$1.3 Billion or US$23.35 Per Share in Cash Sen. Grassley Says Independent Reviews of FDA Employee Misconduct Will Better Serve Public
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