Pharmaceutical Industry News Archive

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January 2007

January 11

The National Association of Boards of Pharmacy Warns About the Continued Dangers of Counterfeit Prescription Drugs Prescription Drugs - An Overview of Approaches to Negotiate Drug Prices Used by Other Countries and U.S. Private Payers and Federal Programs GenVec Receives Clearance From FDA for EUS Administration of TNFerade Elaprase for the Treatment of Hunter Syndrome Approved by the European Commission Wyeth and Solvay Enter Into an Additional Neuroscience Collaboration Bristol-Myers Squibb and AstraZeneca Announce Worldwide Collaboration to Develop and Commercialize Diabetes Compounds Astellas Terminates Agreement on Acute Heart Failure Agent Carperitide The European Commission Approves First and Only Enzyme Replacement Therapy for Hunter Syndrome Bayer and Onyx Announce Pivotal Nexavar Kidney Cancer Study Published in New England Journal of Medicine FDA Clarifies Path to Review Completion for MDS Bioanalytical Clients Biopure Provides Further Comment on U.K. Regulatory Body Letter Regarding Marketing Application for Hemopure Valeant Pharmaceuticals & Metabasis Therapeutics Close Licensing Deal with Schering-Plough Corporation FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products U.S. Congress Threatens Canada's Prescription Drug Supply Entelos Acquires Option to Phase I Compound from Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Organon to Submit Antidepressant Mirtazapine for Approval in Japan Significantly Earlier Than Expected Lilly Announces Strategic Changes to its Global Manufacturing Operations AstraZeneca and Bristol-Myers Squibb Announce Worldwide Collaboration To Develop And Commercialise Diabetes Compounds PhRMA Statement on PDUFA Reauthorization Proposals PRESCRIPTION DRUGS- An Overview of Approaches to Negotiate Drug Prices Used by Other Countries and U.S. Private Payers and Federal Programs FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program

January 12

Astellas Pharma US, Inc. Announces Availability of Mycamine 100mg Vial SCAI Issues Clinical Alert on Drug-Eluting Stents and Late Thrombosis Bioinvent Enters Collaboration with Genentech to Develop and Commercialize Bioinvent's Proprietary Antibody for the Potential Treatment of Cardiovascular Diseases Forest Laboratories Announces Completion of Acquisition of Cerexa, Inc. Cipralex Approved for the Treatment of Obsessive Compulsive Disorder UCB and Schwarz Pharma Start Preparations for Domination and Profit Transfer Agreement UCB and Schwarz Pharma Reach Principle Decision on Group Integration by Domination and Profit Transfer Agreement Euroscreen Products SA Acquired by PerkinElmer Inc. First Roche GS-FLX Genome Sequencing System Installed at VBI ReNeuron to Commence Phase I Study of ReN001, Stem Cell Therapy Sanofi-Aventis Intends to Contest in Court the Decision to Classify Acomplia Among Non-reimbursable Drugs in Germany Rep. Pelosi: Requiring Medicare Prescription Drug Negotiation Is a Resounding Victory for America’s Seniors

January 16

Study finds 90 Percent of Actiq 'Lollipop' Prescriptions are Off-label Enrollment Completed in Pivotal Phase III Study Comparing Prasugrel to Clopidogrel in Patients With Acute Coronary Syndrome Merck Serono Completes Patient Enrollment in CLARITY Phase III Pivotal Clinical Trial of Oral Cladribine UK Court of Appeal Releases Decision on Angiotech Patent Boston Scientific Comments on U.K. Court Decision on Angiotech Patent Forest Laboratories, Inc. Reports Q3'07 Diluted Earnings Per Share of $0.78 Beijing Med-Pharm Corporation Wins Bidding for Shares of Chinese Drug Distributor Shanghai Rongheng Wellbutrin XR Receives First European Approval European Union Meeting Performance Goals for New Drug Review, But Lags Behind U.S. in New Drug Availability, According to Tufts Center for the Study of Drug Development Merck Serono Announces Positive Results From Phase III Diet Study of Phenoptin for Phenylketonuria Genizon BioSciences Announces a License and Collaboration Agreement with Pfizer in Three Major Diseases Neupro Now Approved in Europe for All Stages of Parkinson's Disease Inex Pharmaceuticals Announces Appeal Date for Spin-out of Tekmira Pharmaceuticals Crucell Announces Star Research License Agreement with Novo Nordisk A/S MediciNova Announces Results From a Phase II/III Interstitial Cystitis Trial With MN-001 More European Patients with Epilepsy to Benefit from Keppra Nycomed Officially Launched as Combined Group

January 17

Barr Launches Generic Metaglip Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg Eisai Research Institute Opens New 150,000 Square Foot Facility in Andover to Enhance Basic Discovery Research Capabilities New Transfusion Therapies Company to Be Named 'Fenwal' Archemix and Merck KGaA to Collaborate on Aptamer-Based Cancer Therapeutics GlaxoSmithKline Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development Cipher's Response to Approvable Letter for CIP-ISOTRETINOIN Accepted for Review by FDA Evidence Lacking to Support Many Off-Label Uses of Atypical Antipsychotics Bureau of Competition Issues FY 2006 Summary of Pharmaceutical Company Settlement Agreements Additional Generic Versions of Blockbuster Cholesterol-Lowering Drug Zocor Creates Generic Competition and Significantly Reduces Costs Vioxx Trial Update:Statement on Vioxx Product Liability Trial in New Jersey

January 18

Anesiva Announces Clinical Data From Phase 1 Trial of 1207 GlaxoSmithKline Initiates Head-to-Head Study of Cervical Cancer Vaccines IMPAX Files Amendment to Vadova NDA Preliminary Results: Merck KGaA Posts Record 2006 Profit After Tax of EUR 1 Billion Adherex Buys Out Eniluracil Development Options From GlaxoSmithKline FDA Approves 18-Month Shelf Life for Taxus Stent System Novartis Strategic Healthcare Portfolio Drives Sustained Strong Performance with Record Full-year Results in 2006 Exforge Approved in Europe as Powerful New Blood Pressure Therapy Combining Two Leading Medications in a Single Pill NicOx Receives Euro 5 Million Milestone Payment From Merck & Co. for Antihypertensive Collaboration Pfizer's Sutent Is Granted Full Marketing Authorization for First-Line Use in Advanced Kidney Cancer in the European Union Submission of an Application for an additionalIndication of Actos in Japan; Concomitant Therapy with Biguanides for Type 2 Diabetes Endo Pharmaceuticals Receives Subpoena From U.S. Department of Health and Human Services Hospira Acquisition of Mayne Pharma Clears U.S. Antitrust Review Cipralex Approved in Europe for the Treatment of Obsessive Compulsive Disorder FTC Challenges Hospira/Mayne Pharma Deal

January 22

Pfizer Achieves Key 2006 Financial Targets PharmAthene and Healthcare Acquisition Corp. Announce Definitive Merger Agreement FDA Commissioner Announces Important Personnel Changes FDA Sends Daiichi Sankyo Warning Letter Novartis and Mochida Pharmaceutical to Co-promote Diovan in Japan Evotec Wins Key Contracts With Solvay Pharmaceuticals: Fragment-Based Drug Discovery and a Third Extension of the Library Synthesis and Medicinal Chemistry Collaboration Eisai Announces Inovelon Receives Marketing Authorization Approval from European Commission Paramount Acquisition Corp. Announces Termination of Proposed Business Combination With BioValve Technologies, Inc. Plaintiff Drops Vioxx Suit Against Merck Five Weeks Before First Trial in Philadelphia State Court AstraZeneca Makes $100M Research Investment In Boston Pfizer Announces Priorities to Drive Improved Performance, Position Company for Future Success and Enhance Total Shareholder Return Acumen Pharmaceuticals Inc. Announces Milestone Achievement in Collaboration With Merck & Co., Inc.

January 23

Daily Use of Antidepressants Associated with Increased Risk of Fracture in Older Adults Johnson & Johnson Reports Fourth-Quarter and Full-Year 2006 Results Otsuka Pharmaceutical Co., Ltd. Announces Establishment of New Organization Astellas Receives an Action Letter from FDA for NDA of FK506 MR in the U.S. Shire Licenses the North American Rights for SPD754 (apricitabine) to Avexa Ltd Stiefel Laboratories Receives FDA Approval of Olux-E (Clobetasol Propionate) Foam, 0.05% for Treatment of Psoriasis and Eczema Cell Therapeutics Reaches Agreement With U.S. Attorney's Office Neurocrine Announces Plans to Resubmit NDA for Indiplon Capsules in Q2 2007 Coley Pharmaceutical Group Suspends Independent Development of Actilon; Concentrates Efforts on Preclinical TLR Therapeutics Product Candidates Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder

January 24

FDA Statement on Effectiveness of Newer Birth Control Pills Abbott Reports Strong Fourth-Quarter Results and Record Operating Cash Flow in 2006 Kirin and Astellas Enter Into Licensing Agreement on Immunosuppressive Fully Human Monoclonal Antibody Renovis Restructures to Focus on Advancing Its Neurological and Inflammatory Disease Programs Into Clinical Trials Merck Serono Has Initiated the ONWARD Study to Evaluate Oral Cladribine as Add-on Treatment for Multiple Sclerosis Lucentis Receives Approval in the European Union The Medicines Company Determines Not to Proceed with Proposed Offering First Actemra Multinational Phase III Trial Demonstrates Significant Improvement in Signs and Symptoms of Rheumatoid Arthritis MichBio Will Assist Displaced Pfizer Employees Innogenetics Files to Reinstate Jury's Willfulness Verdict in Successful Patent Infringement Case Against Abbott Laboratories Newer Class of Antidepressants Similar in Effectiveness, But Side Effects Differ

January 25

Cardiovascular Drugs, Four Other Therapeutic Classes of Drugs Dominate the Market WHO Revives Efforts to Eliminate Forgotten Disease Bristol-Myers Squibb Company Reports Financial Results for the Fourth Quarter and Twelve Months of 2006 and Announces EPS Guidance for 2007 Baxter's Fourth Quarter Financial Results Exceed Expectations Biogen Idec Initiates Phase III Trial of Galiximab for Follicular Non-Hodgkin's Lymphoma Akzo Nobel Reconfirms Listing of Organon BioSciences Cardinal Health to Sell Pharmaceutical Technologies and Services Segment to The Blackstone Group for $3.3 Billion Nippon Shinyaku, Apogepha Terminate Development of NS-8, for the Treatment of Overactive Bladder Bayer Discontinues Trasylol Clinical Trial Program in Non-CABG Indications Januvia, First in New Class of Oral Treatments Known as DPP-4 Inhibitors, Recommended for Approval for the Treatment of Type 2 Diabetes in the European Union Committee for Medicinal Products for Human Use Summary of Positive Opinion for Xelevia Committee for Medicinal Products for Human Use Summary of Positive Opinion for Januvia Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Xyrem Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Prevenar ICOS Shareholders Vote to Approve Merger With Eli Lilly FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine

January 26

Pfizer Gains Favorable Ruling From Canadian Court on Lipitor Basic Patent, Will Appeal Ruling on Calcium Salt Patent Copegus Approved in Japan as Combination Therapy with Pegasys for Patients with Chronic Hepatitis C Astellas and Pfizer Reached Settlement on Declaratory Judgment Action Relating to Lipitor Agreement BioVeris Completes Additional Vaccine License Antiviral Agent Copegus Tablet 200 mg Received Approval as a Combination Therapy with Chronic Hepatitis C Treatment Drug Pegasys European Medicines Agency Adopts Positive Opinion Recommending Approval of Xyrem for the Treatment of Narcolepsy with Cataplexy in Adult Patients Amgen's Fourth Quarter 2006 Revenue Increased 17% to $3.8 Billion; Full Year 2006 Revenue Increased 15% to $14.3 Billion Bayer Schering Pharma AG Announces Oral Formulation of Fludara Approved in Japan Illumina Announces the Completion of Its Acquisition of Solexa

January 29

USP Publishes Standards for Medications for Neglected Diseases iCardiac Technologies Enters Into Cardiac Safety Alliance With Pfizer Kyowa Hakko Nine-Month Operating Income up 17.5% Unigene Enters Supply Agreement to Manufacture Osteoporosis Peptide Tarceva : European Approval for Pancreatic Cancer Treatment OSI Pharmaceuticals Announces European Regulatory Approval of Tarceva for Treatment of Patients with Pancreatic Cancer GlaxoSmithKline Files Its New Pre-Pandemic Influenza Vaccine in Europe Genelabs Technologies Announces Sale of Equity in Taiwan-Based Biotechnology Company Shionogi: Consolidated Financial Results for the Third Quarter of Fiscal Year 2006 Genentech and Tanox Receive 'Second Request' from the Federal Trade Commission Schering-Plough Reports Financial Results for 2006 Fourth Quarter, Full Year FDA MedWatch: Aranesp (darbepoetin alfa) Study Showing the Drug Ineffective in Reducing RBC Transfusions or Fatigue in Cancer Patients with Anemia and a Higher Mortality Rate Observed in the Aranesp Treatment Group Pharmion Corporation Announces FDA Approval of Vidaza NDA Supplement for IV Administration Wyeth Pharmaceuticals Listed as the Best 10 Pipeline for the Third Consecutive Year by R&D Directions Magazine United States Joins Suit Against Pharmaceutical Manufacturer Boehringer Ingelheim Roxane Inc.

January 30

Innovative Long-Acting Contraceptive Product Mirena Approved in Japan Merck Announces 2006 Financial Results that Demonstrate Solid Revenue Growth Merck Serono Launches Easypod, First Electronic Growth Hormone Injection Device Proton Pump Inhibitor Pariet Tablets 10mg Receives Approval in Japan for Helicobacter Pylori Eradication Lilly Announces Completion of ICOS Corporation Acquisition Wyeth Reports Earnings Results for the 2006 Fourth Quarter and Full Year P&G Delivers 17% EPS Growth - Raises Fiscal Year Outlook Leading Healthcare Companies Join in Major Research and Development Effort to Prevent Heart Attack and Stroke New Physician Survey Finds FDA Too Slow in Approving New Drugs and Devices A New Laser Weapon Against Counterfeit Drugs LifeSpan BioSciences Enters into Agreement with Roche for Expanded DrugTarget Localization Database FDA Approves NovoLog Category Change for Use in Pregnant Women with Type 1 Diabetes Pfizer Canada to Streamline Pharmaceutical Operations to Improve Performance and to Better Meet Emerging Customer and Business Needs

January 31

NeuroDerm's Transdermal L-DOPA Parkinson's Patch Completes First Clinical Trial The Practice of Authorized Generics During the 180-Day Exclusivity Period May Be Nearing its End With the Introduction of S. 438 - 'The Fair Prescription Drug Competition Act of 2007' AstraZeneca and Palatin Technologies Announce Worldwide Collaboration to Discover, Develop and Commercialise Obesity Compounds Lilly Announces 2006 Adjusted EPS of $3.18 Excluding Charges and Reported EPS of $2.45 FDA Reinforces Commitment to Drug Safety Avanir Receives FDA Approvable Letter for New Formulation of Currently Marketed Antipsychotic Drug FazaClo Novo Nordisk: Financial statement for 2006 CSL to File Pandemic Vaccine Dossier with the Therapeutic Goods Administration Daiichi Sankyo: Consolidated Financial Results for the First Nine Months of Fiscal 2006 YM BioSciences Announces Termination of the Tesmilifene Phase III Pivotal Trial in Advanced Breast Cancer Mylan Laboratories Announces Strategic Global Reorganization to Maximize Growth Opportunities and Leverage Efficiencies Provided by New Global Platform Polydex Pharmaceuticals reports Phase III trial of Ushercell for HIV Prevention Halted
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