Pharmaceutical Industry News Archive
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November 2008
November 3
Over 60 Million U.S. Adults Engaging in Health 2.0
Tweens and Teens Double Use of Diabetes Drugs
Daiichi Sankyo Acquires Merck Serono's Cardio-Metabolism Sales Force and Products in Turkey
Caraco Pharmaceutical Laboratories, Ltd. Receives FDA Warning Letter
Avigen Announces Restructuring and Strategic Direction
November 4
John Patterson to Retire from AstraZeneca
Genzyme and Osiris Partner to Develop and Commercialize First-in-Class Adult Stem Cell Products
Replidyne and Cardiovascular Systems Sign Merger Agreement
Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra and Launches Immediately
November 5
Westaim Terminates Reorganization Agreement and Cancels Shareholders' Meeting
Drug Companies Gave Vermont Health Care Providers Gifts Worth $4.9 Million Over Two Years
Grassley Calls on FDA Leaders to Address Mismanagement of FDA Employee Pay and Benefits
Hospira Reports Third-Quarter 2008 Results
ImClone Systems Announces Expiration of Hart-Scott-Rodino Waiting Period
Shire Successfully Settles Former TKT Shareholder Appraisal Rights Litigation
Urigen Outlines Operating Plans
November 6
FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
King Pharmaceuticals Reports Third-Quarter 2008 Financial Results
Pfizer Discontinues Development Program for Its Phase 3 Obesity Compound (CP-945,598)
Teva Reports Third Quarter 2008 Results
Devgen announces the intention to close its pharma division and to fully focus on the development of its agro business
Sanofi-aventis to Discontinue all Clinical Trials with rimonabant
Teva Updates 2008 Financial Outlook
November 7
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
Express Scripts Warns of Potential Large Data Breach Tied to Threat
Novo Nordisk Invests Close to 400 Million US Dollars in New Insulin Production Plant in China
Amgen Positioned to Deliver Attractive Growth Over Next Five Years
CHI Congratulates Congressional Election Winners
November 10
Sanofi Pasteur First International Vaccine Company to Enter Japan With Pediatric Vaccine ActHIB (Haemophilus Influenzae Type b Vaccine) Available in Japan on December 19, 2008
Biovest International Announces Reorganization Plan to Maximize Long-Term Shareholder Value, Fully Pay All Creditors and Continue Operations to Commercialize its Drugs and Technologies
November 11
Amylin Pharmaceuticals Announces Strategic Restructuring and Workforce Reduction
ASI Announces Results of Advertising Specialties Impression Study
Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring
New study: A Common Class of GI Medications Reduce Protection Against Heart Attack in Patients Taking Widely Prescribed Cardiovascular Drug
November 12
Russia Chooses Inactivated Polio Vaccine from Sanofi Pasteur for Primary Immunization of all Infants
GeneNews Restructures Operations
FDA Approves 30-Minute Onset of Action for Focalin XR
Express Scripts Reports New Threats Tied to Data Security Breach
GlaxoSmithKline Commences Tender Offer to Acquire Genelabs Technologies, Inc.
November 13
FDA Updates the Early Communication about the Ongoing Safety Review of Bisphosphonates
FDA Warns Public of Extortion Scam by FDA Impersonators
Pharmaceutical Industry Needs To Speed Up Transformation To Meet Changing Market Dynamics, According To Ernst & Young Report
FDA MedWatch- Bisphosphonates-Update To The Early Communication Issued Regarding Atrial Fibrillation With Bisphosphonates
FDA Warns Public of Extortion Scam by FDA Impersonators
Public Statement On Exubera (Insulin Human) Withdrawal Of The Marketing Authorisation In The European Union
Novo Nordisk Launches Levemir Satisfaction Guarantee Program
November 14
Actavis Comments on Filing of DOJ Complaint
Pfizer Launches Global Regenerative Medicine Research Unit
Valeant Pharmaceuticals Acquires DermaTech
Senate Finance Chairman Baucus Unveils Blueprint for Comprehensive Health Care Reform
The U.S. Remains Preferred Market for Launching New Products
Javelin Pharmaceuticals Announces 15 Percent Reduction in Workforce
November 17
FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder
Roche, Merck Serono and Abbott Join Forces in Biotechnology Cluster Rhine-Neckar (BioRN)
Out-of-Pocket Costs Grow in Medicare Part D
FREEDOM-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint
Solvay Pharmaceuticals Discontinues R&D Activities of its Anti-Obesity Compound SLV319
Progenics Announces Wyeth Has Received Relistor Approval in Australia
BioSante Pharmaceuticals Announces Receipt of NIH Grant for Inhaled Interferon
Mortara Instrument Announces Extension of ECG Warehouse CRADA With US FDA
November 18
ImClone Systems Announces Clearance of Tender Offer by German FederalCartel Office
Genentech Issues Dear Healthcare Provider Letter Regarding a2nd Case of PML in a Raptiva Patient
ACI’s FDA Boot Camp is the industry standard in providing non-regulatory professionals with the regulatory foundation critical to success
Manhattan Research Releases Report on the Future of Physician Customer Service Portals
AstraZeneca Appoints Rich Fante as President of its U.S. Business
I'm Sticking With My Brand: Loyal Customers Perceive Competitor Ads Differently
Study Finds Cost of Diabetes in the United States Exceeds $217 Billion
Sanofi-Aventis Pharma S.A. Withdraws Its Application for an Extension of Indication for Taxotere and Docetaxel Winthrop (docetaxel)
Public Statement on Forcaltonin - Withdrawal of the Marketing Authorisation in the European Union
Telephone Counseling May Improve Effectiveness of Varenicline (Chantix), According to Free & Clear Study
ACP Guideline Finds No Substantial Differences Among “Second-Generation” Antidepressants
November 19
Novartis highlights innovative approach to drug discovery with dynamic advance in exploratory pipeline
Barr Announces Agreements on Nasacort AQ, Allegra D-12 and Allegra Patent Challenges
ADHD Medications Do Not Cause Genetic Damage In Children
Teva Receives First U.S. Approval for Generic Pulmicort Respules;Commences Commercial Launch
Widely-Used Cancer Drug Associated With Significantly Increased Risk of Blood Clots
Prescription Project Welcomes U.S. Appeals Court Ruling in “Data-Mining” Case
Nevada Attorney General Cortez Masto Files Suit Against Hormone Therapy Drug Manufacturers
IMS v. Ayotte - Physician Privacy Law Upheld as Constitutional by First Circuit
Media Statement re: New Hampshire's Decision to Overturn a New Hampshire U.S. District Court Ruling that Struck Down the State’s Law Banning the Commercial Use of Prescriber-Identifiable Data
AstraZeneca Enters Agreement for Authorized Generic Pulmicort Respules
WebMD and Marketing Technology Solutions Terminate Merger Agreement
Ambrilia Initiates Plan Aiming to Significantly Reduce its Operations in France
Orion to Renew Operational Model of Pharmaceutical R&D. Negotiation Proposal on Reduction of up to 300 Employees in Finland
November 20
Pfizer Withdraws Application to Switch Viagra to Non-PrescriptionStatus in Europe
BIO Congratulates Former Senator Tom Daschle on His Nomination toServe as HHS Secretary
ImClone Systems' State-of-the-Art Manufacturing Facility Receives FDA Approval for Multi-Product Biologics Production
FDA Advisory Committee Provides Opinion on Oritavancin for theTreatment of Complicated Skin and Skin Structure Infections
AstraZeneca to Realign Supply Chain to Improve Productivity and Move Closer to Customers
Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
AstraZeneca Granted Temporary Restraining Order in Pulmicort Respules Patent Litigation
New Jersey Jury Awards $12.9 Million to Three Patients Whose Use of Roche Acne Medication Accutane Found to Cause Severe Bowel Illness
Cervarix, GSK’s Cervical Cancer Vaccine, Wins Tender for Dutch National Immunisation Programme
FDA Sends Warning Letter to Shionogi Over Cedax Direct Mailers
European Medicines Agency Recommends the Suspension of the Marketing Authorisation of Ionsys (fentanyl hydrochloride)
FDA Sends Letter to Protherics Over Voraxaze Web Material
Internet Advertising Revenues in Q3 ’08 at Nearly $5.9 Billion
November 21
Vical Announces Strategic Restructuring and Staff Reduction
SurModics Announces Changes to Its Organizational Structure and Cost-Cutting Initiatives
Par Pharmaceutical Halts Shipment of Budesonide Inhalation Suspension
CombinatoRx Concentrates on Core Strengths
Lilly Completes Cash Tender Offer for ImClone Systems
Nplate (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union
MINRAD International, Inc. Announces Reduction in Workforce
CHMP Posts 12 Opinions
Physicians Anticipate Higher Prescribing Based on JUPITER Study
Barr Shareholders Approve Pending Teva Acquisition
New Data: Advanced Pharmacy Model Significantly Reduces Gaps in Care for Patients with Chronic and Complex Conditions; Improves Clinical and Financial Outcomes
November 24
Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA
King Pharmaceuticals To Acquire Alpharma for Approximately $1.6 Billion
Johnson & Johnson Announces Definitive Agreement to Acquire Omrix
PhRMA Statement on New National Advertising Campaign
FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months
XDx Announces Strategic Restructuring
Lilly Completes Acquisition of ImClone Systems
Schering-Plough Highlights R&D Pipeline Progress, Innovation and Breadth of Research Projects
Genzyme Seeks U.S. Approval for Clolar to Treat Adult AML
November 25
AstraZeneca Provides Update on Agreement with Abraxis Biosciences for Co-Promotion of Abraxane in the US
Roche Signs Definitive Agreement to Acquire Memory Pharmaceuticals
Watson Enters Into Agreement to Acquire Products Related to Teva's Proposed Acquisition of Barr
Antitrust: European Commission Confirms Unannounced Inspections at Pharmaceutical Companies
Anika Therapeutics Terminates Contract with U.S. Distribution Partner for ELEVESS
Bayer Healthcare to Pay U.S. $97.5 Million to Settle Allegations of Paying Kickbacks to Diabetic Suppliers
Bayer Healthcare llc Reaches Settlement with U.S. Department of Justice on Investigation into former Diabetes Care Marketing Programs
November 26
FDA Sends Warning Letter to Actelion Over Tracleer Flash Card
Use Of Inhaled Corticosteroids For Copd Does Not Appear To Improve Survival, But May Increase Risk For Pneumonia
FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections
Pfizer's Novel HIV/AIDS Treatment Selzentry Becomes the Latest Fully Approved Antiretrovial for Treatment-Experienced HIV Patients
Ceregene Announces Clinical Data From Phase 2 Clinical Trial of CERE-120 for Parkinson's Disease
Growth hormone not beneficial for ALS
