Pharmaceutical Industry News Archive

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March 2007

March 7

Wyeth and Progenics to Begin Clinical Testing of a New Formulation of Oral Methylnaltrexone Based on Phase 2 Findings ZymoGenetics Provides Update on rhThrombin Development Plans Thelin (sitaxentan sodium) Receives Australian Marketing Approval Authentix Partners with AstraZeneca to Protect Drug Supply with Unit-Level Mass Serialisation Avalon Pharmaceuticals and Merck & Co., Inc. Establish a Drug Discovery, Development and Commercialization Collaboration Litigation Settlement Reached Between Tercica, Genentech and Insmed Use of ADHD Medication Soars Worldwide CV Therapeutics Announces Topline MERLIN TIMI-36 Results AARP Presses Case for Rx Importation Pharmaceutical Company Ordered to Withdraw Advertising AARP Watchdog Report Shows Drug Prices Continue to Soar Lipitor Receives FDA Approval for Five New Indications in Patients With Heart Disease Acambis Restructures Organisation to Focus Resources on Key Programmes and Operations, and Reduce Cost Base by 20% Insmed Announces Restructure, Settlement Ending Iplex Patent Dispute Publicis Groupe Announces Acquistion of Pharmagistics (USA), Leader in Prescription Drug Compliance, Move Boosts PHCG's Technological and Digital Expertise African-American Doctors Say DTC Ads Improve Doctor-Patient Relationships and Educate Patients

March 9

Engel Publishing Partners Celebrates Its 25th Year as a Leading Pharmaceutical Information Provider U.S. Court of Appeals Reinstates Permanent Injunction Against Abbott Laboratories for Infringing Innogenetics' Patent Dorland Global Corporation Acquired by Huntsworth PLC IMS Health Reports U.S. Prescription Sales Jump 8.3 Percent in 2006, to $274.9 Billion FDA Sends Letter to Takeda Over Rozerem Advertisement Roche Files Supplemental New Drug Application with U.S. Food & Drug Administration for Tamiflu 30 mg and 45 mg Capsules PhRMA to Present Clinical Trial Exceptional Service Award Amgen Announces Update To U.S. Prescribing Information for Aranesp and Epogen Galen Partners and Arena Capital Partners Complete Sale of EduNeering Holdings, Inc., to Kaplan, Inc. Ortho Biotech Revises Prescribing Information for Procrit (Epoetin alfa)

March 13

Sleeping Pill Advertisement Targeting Children Illustrates Need for Congress to Reform Prescription Drug Ads Allegra (fexofenadine hydrochloride) Oral Suspension Now Available to Help Manage Seasonal Allergy Symptoms In Children Merck & Co., Inc. to Appeal Humeston Vioxx Verdict Cellzome Receives First Milestone Payment for Alzheimer's Program from Ortho-McNeil Pharmaceutical, Inc. Baxter's Board of Directors Expands Share Repurchase Authorization By $2 Billion Pediatric Study Costs Rose Substantially from 2000 as Complexity Grew, According to Tufts Center for the Study of Drug Development Ecopia and Caprion Complete Combination and Announce Closing of $45 Million Private Placement: New Entity Called Thallion Pharmaceuticals Inc. Inflazyme Announces Outcome of Review of Phase 2b Asthma Study: Potential Mitigating Factors Identified which Prevent Clear Interpretation of Results FDA Approves Tykerb (lapatinib) in Combination With Xeloda (capecitabine) for the Treatment of Advanced or Metastatic Breast Cancer in Women Who Have Progressed on Prior Therapy Illumina Announces Outcome of First Phase of Its Patent Litigation against Affymetrix

March 14

Cancer Drug, But Not Drug Company, Praised By Networks Neuromed Receives Milestone Payment of $2 Million Under Collaboration and License Agreement with Merck & Co., Inc. Baxter Holds 2007 Investor Conference in Chicago Bristol-Myers Squibb Significantly Expands Research And Development Presence In India Through Collaborations With Biocon And Accenture Study of Drug Therapy for Compulsive Buying Yields a Puzzle, Stanford Researcher Says Maxygen Announces End of Co-Development Agreement IR BioSciences, Inc. Responds to the Recently Cancelled Acute Radiation Syndrome (ARS) RFP by DHHS FDA Requests Label Change for All Sleep Disorder Drug Products Biopartners Holdings AG Purchased by Bioton S.A. Consona Corporation (M2M Holdings, Inc.) Closes on Acquisition of KNOVA Software, Inc. Eli Lilly and Company CEO Says Biomedical Breakthroughs Are Transforming Medicine and Promise to Radically Ease the Impact of Aging

March 19

Curecumin May Be an Effective Treatment for Prostate Cancer Coronary Artery Disease ARISE Trial Showed AGI-1067 Did Not Meet Primary Endpoint Evotec and Boehringer Ingelheim Enter Into Target Discovery Collaboration in Alzheimer's Disease Update: FDA Approves Alexion's Soliris for All Patients With PNH Medivir Receives Shares and Cash Payment from Epiphany Biosciences Social Networks Impact the Drugs Physicians Prescribe According to Stanford Business School Research Beijing Med-Pharm Corporation Signs Definitive Agreement for the Acquisition of Majority Interest in Shanghai Rongheng Pharmaceutical Co., Ltd. Auriga Laboratories Sales Force Doubles Again to 200 Associates Since January Shire Announces Expiration of Hart-Scott-Rodino Waiting Period AtheroGenics Reports ARISE Trial Results for AGI-1067 Inyx Reports Update on Corporate Matters WellPoint Expands GenericSelect Program to Include Generic Version of Blockbuster Cholesterol-Lowering Treatment Zocor IMS Health Acquires ValueMedics Research in the U.S., Extending Capabilities to Demonstrate Value of Medicines

March 20

Hold the Pickles and the Penicillin: Leading Food-Service Company to Serve Antibiotic-Free Hamburgers Nationwide Cetero Research Acquires Allied Research International, Gains Specialty Clinical Experience InterMune Updates Expense Forecasts and Development Plans 3SBio Inc. Announces Addition to Product Portfolio Astellas Receives and FDA Action Letter for Prograf sNDA Takeda's New Structure for Pharmaceutical Marketing Division in Japan Takeda Submits a European Marketing Authorization Application for Ramelteon, a New Treatment for Insomnia Corcept Therapeutics Announces Phase 3 Study Evaluating Corlux for Psychotic Major Depression Misses Primary Endpoint Medical Discoveries Inc. Engages Strategic Advisor to Explore Alternatives Taro Files 2005 Form 20-F Following Completion of 2005 Audit Barr Confirms Filing an Application with a Paragraph IV Certification for Abilify Tablets New Data from the US and Japan Support: No Established Causal Link Between Neuropsychiatric Symptoms and Treatment with Tamiflu US Databases Indicate Psychiatric Symptoms Lower in Influenza Patients Taking Tamiflu Versus Those Not Taking Tamiflu New Cancer Practice Guidelines Recommend Noxafil (Posaconazole) for Antifungal Prophylaxis in Certain High-Risk Patients New Treatment Option for Epilepsy Patients With One of the Most Debilitating Seizure Types Pfizer Wins Celebrex Patent Challenge by Generic Manufacturer Teva

March 22

Conceivex At-Home Conception Kit Puts Couples in Control of Their Fertility Eisai To Acquire Morphotek Dey, L.P. Reaches Settlement with State of Hawaii on Pricing Litigation Cubist Pharmaceuticals Licenses Rights for Development and Commercialization of Cubicin in Japan to Merck & Co., Inc. PDI, Inc. Comments on Status of a Substantial Contract Sales Program Reps. Dingell, Stupak Call on Amgen, Johnson & Johnson to Suspend Direct-to-Consumer Marketing for Anemia Drugs Bayer Schering Pharma Presents Innovations in Men's Healthcare at the 22nd Annual Meeting of the European Association of Urology (EAU) U.S. District Court Grants Permanent Injunction Prohibiting Mylan from Marketing Generic Version of Topamax Acomplia (rimonabant) is Now Officially Reimbursable in France, for the Treatment of Eligible Obese and Type 2 Diabetic Patients GSK Announces Nationwide Availability of Once-A-Day Coreg CR for the Treatment of Three Key Cardiovascular Conditions GSK Giving Figures Exceed £300m for Fourth Year Running: Medicines for Lymphatic Filariasis Elimination Valued at £16 Million Pharmacist, Patient Groups Call for Inquest into B.C. Counterfeit-Pills Death VASTox plc Acquires DanioLabs Ltd and Dextra Laboratories Ltd to Strengthen Its Drug Discovery Pipeline and Pharmaceutical Services Business PEDIATRIC DRUG RESEARCH:Studies Conducted under Best Pharmaceuticals for Children Act DRUGSAFETY: FDA Needs to Further Address Shortcomings in Its Postmarket Decision-making Process

March 23

AstraZeneca Names Shanghai Site As Initial Base for New Innovation Centre China NovaDel's European Formulation of Ondansetron Targeted for U.S. Zensana CDC Finalizes Advisory Panel Recommendations for Gardasil, Merck's Cervical Cancer Vaccine Amgen Discontinues Vectibix Treatment in PACCE Trial Evaluating Vectibix as Part of Triple Combination Regimen Hana Biosciences Provides Pipeline Update Sen. Durbin Amendment to Delay Potential Cuts in Medicaid Payments to Hospitals Nationwide Successfully Addded to Supplemental Spending Bill Procognia Enters Protein Kinase Array Collaboration With GSK Pfizer Statement in Response to Appeals Court Decision in Norvasc Patent Case Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA Leukemic Cells Find Safe Haven in Bone Marrow Marketing Authorisation Application for Ambrisentan Validated by European Medicines Agency Genentech to Provide Business Update at Annual Investment Community Meeting UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US Flamel Technologies Welcomes Nationwide Availability of Coreg CR Dalton Medicinal Chemistry Partners and Boehringer Ingelheim (Canada) Ltd. enter into a Medicinal Chemistry Agreement European Medicines Agency Statement on Safety of Tamiflu Avicena Clarifies Description of Creatine Versus PD-02, Company's Lead Drug Compound Used in NIH Phase III Clinical Trial in Parkinson's Disease Mylan Laboratories Launches Amlodipine Besylate Tablets and Has Triggered Its 180 Days of Exclusivity Advancis Pharmaceutical Resubmits New Drug Application for Once-Daily Amoxicillin PULSYS

March 26

Mylan Announces Another First to Market With the Launch of Ciprofloxacin Extended-Release Tablets Arrowhead to Form New Nanomedicine Subsidiary and Acquire Nanotherapeutics Company, C Sixty, Inc. First Study To Show Positive Benefit On Atherosclerosis For People With Early Signs Of Diseased Arteries Abbott Announces Positive Six-Month Results From the World's First Clinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary Stent Bayer Deal with Novartis Improves Profit Outlook for Betaseron Franchise Abbott's Xience V Everolimus Eluting Coronary Stent Superior to Taxus Stent in Spirit III U.S. Pivotal Clinical Trial Novartis to Launch Its Own Branded Version of a Leading Multiple Sclerosis Therapy Through Agreement with Bayer Schering Pharma Insmed Withdraws Its Marketing Authorisation Application for Iplex Genta Announces Expectation of a Negative Opinion from the CHMP on Genasense Application for Advanced Melanoma Januvia Approved in the European Union for the Treatment of Type 2 Diabetes Asahi Kasei Pharma Corporation and Eisai Co., Ltd. Signed License Agreement for Vasodilator Eril in Korea Schering-Plough and Merck to Develop Another New Cholesterol Lowering Medicine Herceptin Receives Positive Opinion in Europe for Use in Combination with an Aromatase Inhibitor for the Treatment of Patients with Her2- and Hormone Receptor-positive Metastatic Breast Cancer Scios Announces Results From Exploratory Nesiritide Study Providing Important New Renal and Mortality Safety Data with a Neutral Effect on the Primary Endpoint Everest Data on Short- and Long-Term Use of Otsuka's Investigational Novel Treatment, Tolvaptan, Published in Journal of the American Medical Association and Featured in ACC's Late Breaking Clinical Trials Cholesterol Drug Fails to Slow Progression of Coronary Disease, Cleveland Clinic Study Reports Wyeth Receives FDA Approval for New BeneFIX Features That Provide Hemophilia B Patients a Simpler and More Convenient Preparation Process for Recombinant Factor IX Shire Announces Posting of Circular, Date of Extraordinary General Meeting and Extension of Tender Offer for New River Shares Until April 17, 2007 Study: Identical Doses of BiDil Components Are Not Bioequivalent to the Fixed Dose Combination-BiDil-Used in A-HeFT Roche Submits Application to the FDA for use of Xelox (Xeloda plus oxaliplatin) With or Without Avastin for the Treatment of Advanced Colorectal Cancer EvoGenix Achieves Milestone in Collaboration with GlaxoSmithKline European Union CHMP Recommends Approval of First and Only Biologic Treatment for Pediatric Crohn's Disease: Remicade

March 27

U.S. District Court Enjoins the FDA from Approving Additional Amlodipine Besylate ANDAs Replidyne Defines Preliminary Phase III Development Plan for Faropenem BioCryst Provides Fodosine Update Acuity Pharmaceuticals and Froptix Corporation Agree to Mergers with Public Shell; New Company to Develop and Market Drugs for Disorders of the Eye BrainCells and Lundbeck Form CNS Drug Research Collaboration FDA MedWatch-KETEK telithromycin) Dear Healthcare Professional letter issued re: safety related labeling changes Lipitor Provides Unprecedented Cardiovascular Risk Reductions in Diabetes Patients with Metabolic Syndrome and in Stroke Patients Boehringer Ingelheim Grows Faster Than the Market Once Again - Spiriva, Micardis and Flomax/Alna the Top Products Seattle Genetics Announces Extension of Antibody-Drug Conjugate Collaboration with Genentech NICE Alzheimer's Treatment Decision Subject to Judicial Review Heart Intervention Doesn’t Outweigh Medicine in Study Merck Wins Product Liability Case in Madison County, Ill. - Schwaller v. Merck Lipitor Significantly Lowered Hospitalization Costs for Patients with Heart Disease, Two New Analyses Show

March 28

Pharmacopeia Earns Milestone Payment From Schering-Plough As Novel Therapeutic Candidate Enters Phase 1 Clinical Trial Sanofi-aventis and Oxford BioMedica Enter Global Licensing Agreement to Develop and Commercialise TroVax For Cancer Cell Signaling Technology Announces Alliance with Merck to Provide PhosphoScan Proteomics & Antibody Development for Biomarker Discovery to Support Oncology Therapeutic Programs Calcium Channel Blocker Adalat GITS Offer Additional Benefits CSL Therapy That Mimics “Good” Cholesterol May Reduce Plaque Volume in Coronary Arteries Merck & Co., Inc. and Lundbeck Discontinue Joint Development Program for Gaboxadol, an Investigational Compound for Insomnia Daiichi Sankyo, Inc. Announces Filing For WelChol Label Change to Include Ezetimibe Efficacy Data Clinical Development Initiated on Lead Compound in NicOx’ Glaucoma Collaboration with Pfizer MorphoSys and Astellas Enter Antibody Partnership Beijing Med-Pharm Corporation Signs Definitive Agreement for the Acquisition of Majority Interest in Shanghai Rongheng Pharmaceutical Co., Ltd. FDA MedWatch: Accutane (isotretinoin)- Webpage Warning Against Buying Product and Generic Versions On Line

March 29

VWR International, Inc. Acquires Remaining Stake in KMF Laborchemie Handels GmbH NicOx Announces that Pfizer has Disclosed Further Details of Glaucoma Trial for PF-03187207 CuraGen Announces Definitive Agreement to Sell 454 Life Sciences to Roche Avastin Approved in Europe for First Line Treatment of Women with Metastatic Breast Cancer KV Pharmaceutical Updates Metoprolol Succinate Application Status Ad hoc Release According to Section 15 WpHG Cytori To Raise $6.0 Million in Strategic Equity Agreement with Green Hospital Supply NeoPharm Reports on FDA Meeting Avanir Pharmaceuticals Provides Business Update and Announces Restructuring Plan Roche Acquires 454 Life Sciences to Strengthen Presence in Ultra-Fast Gene Sequencing R&D Directions’ March Issue Profiles 100 Great Investigational Drugs, Talks with Pfizer’s President of Global Research & Development, and More MedImmune Licenses Reverse Genetics Technology to sanofi pasteur for Use in Influenza Vaccine Production Study Sheds Light on Medication Treatment Options for Bipolar Disorder Athersys Successfully Advancing Multiple Commercial Collaborations GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix

March 30

GlaxoSmithKline Files Meningococcal Conjugate Vaccine Progenics and Wyeth Announce Submission of New Drug Application for the Subcutaneous Formulation of Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients Receiving Palliative Care Astellas Licenses Regeneron's Velocimmune Technology for Discovering Human Monoclonal Antibodies FDA Announces Voluntary Withdrawal of Pergolide Products Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer Xeloda Approved in Europe for the Treatment of Advanced Stomach Cancer European Medicines Agency Recommends Restricted Use and Strengthened Warnings for Ketek LG Life Sciences and Takeda Announce Collaboration for Anti-Obesity Drugs CanBas and Takeda to Sign the Collaboration Agreement for Investigational Compounds for Treatment of Cancer Takeda to Obtain Development and Commercial Rights for R-851 from 3M Galapagos Announces Achievement of Milestones Totaling €3.2 Million in Osteoarthritis Alliance with GlaxoSmithKline Completion of the Acquisition of CellCyte Genetics Corporation (WA) Novartis Suspends US Marketing and Sales of Zelnorm In Response to Request from FDA New Chemistry Approach Promises Less Expensive Drugs Amicus Therapeutics Files For Initial Public Offering
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