Pharmaceutical Industry News Archive
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News Archive for November 2007
November 1, 2007
- 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 2, 2007
- ADVENTRX Provides Update on Cofactor Program
- Dainippon Sumitomo Pharma Signs License Agreement for a Sedative Hypnotic Agent
- Medtronic and Kyphon Complete Merger
- Barr Confirms Patent Challenge of Ritalin LA
November 5, 2007
- 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, 2007
- 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 7, 2007
- Nastech Reacquires Teriparatide (Parathyroid Hormone; PTH1-34) Nasal Spray from Procter & Gamble
- Watson Files FDA Application for Generic YAZ
- Alcon Gains All Regulatory Clearances for Acquisition of WaveLight AG
- Agilent Technologies Signs Agreement to Acquire Velocity11, a Leader in Life Science Lab Automation and Robotics
- Tweens Double Use of Diabetes Drugs
- Omnicare Comments on Analyst and Press Reports
- Entelos Finalizes Initial Consideration for Iconix Biosciences, Inc. Acquisition
November 8, 2007
- 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 9, 2007
- Merck Agreement to Resolve U.S. Vioxx Product Liability Lawsuits
- The Lanier Law Firm Announces $4.85 Billion National Vioxx Settlement with Merck & Co. Inc.
- Results of a Survey of Parents' Perceptions of the Duration of Their Child's ADHD Medication Reported at Medical Meeting
November 12, 2007
- AtheroGenics Modifies ANDES Clinical Trial Discontinuing Highest Dose of AGI-1067
- MedZilla.com Releases its October Employment Outlook Numbers for Biotechnology, Pharmaceuticals, Healthcare & Science
- PAION is Seeking a New US-Partner for Desmoteplase
November 13, 2007
- Nanogen to Close Array Business - Will Focus on Two High Growth Product Lines
- Cegedim Strategic Data (CSD) Acquires 3ES
- Pfizer and Nektar Reach Agreement on Exubera
- Sanofi Pasteur and Acambis Join Forces to Bring West Nile Vaccine to Market
- Orion Sues Sun Pharmaceuticals in the U.S. to Enforce a Patent for Stalevo
- Entelos Announces Expanded Research with Pfizer
November 14, 2007
- 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 15, 2007
- GPC Biotech Announces Corporate Restructuring
- Dragon Sells EPO Business; Focus on Antibiotic Core Business
- Johnson & Johnson Announces Changes to Accelerate Growth
- PerkinElmer Completes Acquisition of ViaCell
- JDRF and Lilly Partner to Fund Research to Identify Beta Cell Biomarkers
- NCCN Receives Major Grant for Anti-Cancer Drug Study
- FDA Announces Steps to Improve Advisory Committee Processes
- Getting Ready Corporation and Winston Laboratories, Inc. Announce Merger Agreement
- Sanofi-aventis Announces New Research Center in Oro Valley
November 16, 2007
- Cambridge Major Laboratories Adds ChemShop B.V.
- UCB to Appeal European Negative Opinion on Cimzia for the Treatment of Patients with Crohn's Disease
- Pfizer to Acquire Coley Pharmaceutical Group
- Argos Therapeutics and Therakos, Inc. Enter Exclusive Agreement for Regulatory T Cell Technology
- Schering-Plough Receives Clearance From U.S. Federal Trade Commission for Planned Acquisition of Organon Biosciences N.V.
- Floor Statement of U.S. Senator Chuck Grassley of Iowa Ranking Member of the Committee on Finance Intimidation of Scientists
November 19, 2007
- Celgene to Acquire Pharmion for $2.9 Billion in Cash and Stock
- Genelabs Technologies Regains Exclusive Rights to Prestara in Japan From Mitsubishi Tanabe Pharma Corporation
- Cognizant Completes the Acquisition of marketRx
- FDA Announces Board Members of Reagan-Udall Foundation
- Nycomed Significantly Increases Profitability
- Boston Scientific Announces Amended Agreement to Settle Product Lawsuits
- Sciele Signs Exclusive Agreement with Novo Nordisk to Market Prandin and PrandiMet
- Schering-Plough Completes Acquisition of Organon BioSciences
- United Kingdom and Germany Suspend Marketing and Sale of Prexige Pending Outcome of European Regulatory Review
- EPO Rules AstraZeneca MUPS Patent Valid
November 20, 2007
November 21, 2007
- 92 Medicines and Vaccines now in Development for HIV/AIDS
- Anika Therapeutics and Galderma Agree to Terminate License, Development and Supply Agreements
- FDA-MedWatch- Chantix (Varenicline)-FDA Reviewing Post Marketing Cases Describing Suicidal Ideation And Occasional Suicidal Behavior
- FDA Issues Early Communication for Chantix
- GSK to Acquire Reliant Pharmaceuticals
- GlaxoSmithKline to Acquire Reliant Pharmaceuticals
- Alkermes Announces Proceeds of Up to $174 Million from Sale of Stake in Reliant Pharmaceuticals and Plans to Repurchase Shares of Its Common Stock
November 26, 2007
- Bristol-Myers Squibb and Pierre Fabre Provide Update On Vinflunine Development Status
- InterMune Buys Out License Agreement for Pirfenidone
- Simcere Acquires Nanjing Tung Chit
- Intercell/Novartis Alliance – Next EUR 80 Million Payment Received
- Maxygen Updates Status of MAXY-alpha Program
- OncoMethylome Sciences to Collaborate with GlaxoSmithKline Biologicals for Personalized Cancer Treatment
- Beijing Med-Pharm Announces Exclusive Agreement to Market Enablex in China
- Targeted Genetics Announces That FDA Has Removed Hold on Phase I/II Clinical Trial of tgAAC94 for Inflammatory Arthritis
- Health Media Announces Acquisition of the Embryon Group Companies
November 27, 2007
- 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 28, 2007
- eResearchTechnology (eRT) Agrees to Acquire the Centralized ECG Business of Covance
- Boehringer Ingelheim Initiates NEwArT Study Comparing Viramune (nevirapine) to a Ritonavir-Boosted Atazanavir-based Regimen in Treatment-Naive HIV Patients
- QLT Board Authorizes Exploration of Strategic Alternatives to Enhance Near- to Mid-Term Shareholder Value
November 29, 2007
- 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
November 30, 2007
- Cardinal Health Receives DEA Order to Temporarily Cease Distribution of Controlled Substances from Auburn, Wash. Facility
- Boston Scientific Welcomes FDA Panel Recommendation to Approve Promus / Xience V Everolimus-eluting Coronary Stent System
- Pfizer Inc Commences Tender Offer for All Outstanding Shares of Coley Pharmaceutical Group, Inc.
- Sanofi-Aventis and Astellas to Restructure the Joint Venture Activities in Japan of Fujisawa Sanofi-Aventis K.K.
- Speedel Receives First Cost-of-Goods Savings for SPP100
