Pharmaceutical Industry News Archive
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News Archive for January 2007
January 2, 2007
January 4, 2007
January 5, 2007
January 9, 2007
- FDA Approves MedImmune's Refrigerated Formulation of FluMist
- Purdue will launch first medication-error investigation program in U.S.
January 10, 2007
- Use of Corticosteroid Inhalers for the Treatment of Asthma and COPD to Increase
- Genentech Announces Full Year and Fourth Quarter 2006 Results
January 11, 2007
- 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, 2007
- 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 13, 2007
January 15, 2007
- Glass Lewis and PROXY Governance Recommend ICOS Shareholders Vote for Lilly's $34 Per Share Cash Merger
- PhRMA Statement on HR 4
- Genzyme Announces Publication of Study Showing Impact of Cerezyme on Bone Health for Patients With Type 1 Gaucher Disease
- Novo Nordisk Focuses Research and Development on Therapeutic Proteins - Discontinues R&D Within Small Molecules
- Tanox, Inc. Stockholders Approve Merger With Genentech, Inc.
January 16, 2007
- 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, 2007
- 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, 2007
- 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 19, 2007
- Vioxx Plaintiffs Failed to Prove Their Cases
- Abbott To Sell Its Core Laboratory Diagnostics Business, Including Point Of Care, To GE For $8.13 Billion
- Lilly ICOS LLC Reports Results for 2006
- S-1 Oral Anticancer Agent Improves Patients' Survival In Adjuvant Gastric Cancer Trial Versus Surgery Alone
- Statin Plus Cancer Drug Deliver Combo Punch to Brain Cancer Cells
- Pharmos Announces Clinical Data from Phase 2a Trial of Cannabinor for Capsaicin-induced Pain
- Mitsubishi Chemical Holdings Corporation: Notice Concerning Certain Media Reports
- Platinum Equity Completes Acquisition of Healthcare Marketing Services Unit from Cardinal Health
- Health Canada Approves Cangene's Anti-Hepatitis B Product
January 22, 2007
- 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, 2007
- 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, 2007
- Kirin and Astellas Enter Into Licensing Agreement on Immunosuppressive Fully Human Monoclonal Antibody
- FDA Statement on Effectiveness of Newer Birth Control Pills
- Abbott Reports Strong Fourth-Quarter Results and Record Operating Cash Flow in 2006
- 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, 2007
- 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, 2007
- 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, 2007
- 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, 2007
- 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, 2007
- 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
