Monday, November 28, 2011

Novartis Snags EU Approval of Combo Pill for High BP - Nov. 28, 2011

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•  Novartis (NVS) Snags EU Approval of Combo Pill for High BP More...
•  Bristol-Myers Squibb Company (BMY) and AstraZeneca PLC (AZN)'s ONGLYZA® (saxagliptin) Approved for Use in Europe as Combination Therapy With Insulin (With or Without Metformin) in Adults With Type 2 Diabetes More...
•  Perrigo Company (PRGO) Receives Final FDA Approval for Store Brand Equivalent to Generic Version of Mucinex® More...
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•  Cipher Pharmaceuticals (DND.TO) Submits NDA Amendment For CIP-ISOTRETINOIN More...
•  Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Submits New Drug Application in the U.S. for Investigational Type 2 Diabetes Therapy, Fixed-Dose Combination Alogliptin/Metformin More...
•  Gilead Sciences, Inc. (GILD) Receives European Marketing Authorization for Eviplera®, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults More...
•  Allergy Therapeutics plc Release: Submissions of Complete Response to PEI in Germany and Clinical Study Protocol to US FDA More...
•  AEterna Zentaris (AEZS): FDA Grants IND to Investigator at Baylor College of Medicine for Phase 2A Trial with AEZS-130 in Cancer Cachexia More...
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•  National Institutes of Health (NIH) Discontinues Tenofovir Vaginal Gel in 'Voice' HIV Prevention Study More...
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•  Celsion Corporation (CLN) Announces Unanimous Recommendation by Independent Data Monitoring Committee to Continue and Complete Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer as Planned More...
•  Ipsen's Partner Inspiration Biopharmaceuticals Announces the Initiation of the Second Phase III Pivotal Clinical Study of OBI-1 in Congenital Hemophilia A With Inhibitors More...
•  A Second Life for Bayer HealthCare (BAY)'s Diabetes Drug in China More...
•  Regeneron Pharmaceuticals, Inc. (REGN) and Bayer HealthCare (BAY) Initiate Phase 3 Clinical Program for the Treatment of Wet Age-Related Macular Degeneration in China More...
•  NicOx SA (COX.PA): Patient Recruitment Completed by Bausch & Lomb in Glaucoma Study More...
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•  PRANA Biotechnology (PRAN) Secures Key Patent for Parkinson's Drug PBT434 in the United States More...
•  AusBiotech Ltd. Supports Government's Response on Patents More...
•  US Patent Office Rejects All 191 Claims in Key MonoSolRx LLC Patent Asserted Against BioDelivery Sciences International (BDSI) More...
•  USPTO Denies Request for Reexamination of Butamax Pioneering Patent and Orders Limited Reexamination of Butamax Second Patent More...
•  Dr. Paul Marks Joins Cellceutix Scientific Advisory Board; Cellceutix Files Worldwide Patents to Protect Kevetrin(TM) More...
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•  Novartis AG (NVS) Halts Delivery to Second German Drug Wholesaler More...
•  Moleac Announces the Launch of NurAiD II in France, a "Recovery Stimulator" Marketed as a Natural Food Supplement More...
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•  Yawning May Cool the Brain When Needed, University of Maryland Study More...
•  Moderate Alcohol Consumption Could Help Prevent Diabetes, Harvard School of Public Health Study More...
•  Ovary Removal Not Tied to Increased Risk of Death, City of Hope Study More...
•  Heart Patients Prefer Longevity Over Quality of Life, University Hospital in Basel Study More...
•  Mediterranean-Ish Diet Tied to Better Heart Health, University of Miami Study More...
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Pharm Country (Wayne, Pennsylvania)

Octagon Research Solutions, Inc.
Clinical Data Project Manager
Provides project management expertise in the planning and execution of regulatory oversight, leadership and oversight of multi-functional task force teams. Reporting directly to the Director of Project Management within our Clinical Data Operations Department.

Biotech Bay (Redwood City, California)

Abbott
Senior Section Manager, Clinical Data Management
Responsibilities may include interaction and coordination with staff across multiple Abbott sites. Represents Clinical Data Management function at internal and regulatory agency audits.

Genetown (Billerica, Massachusetts)

PAREXEL International
Biostatistician II, Clinical Trials
Will work under the supervision of an experienced biostatistician in the production of statistical analysis plans and reports, and provide statistical advice to clients as a key contact with regard to statistical and contractual issues.

Bio NC (Durham, North Carolina)

Cato Research
Director, Clinical Trial Operations
Manages overall operation of the entire clinical study including project planning, budget, resource management and contract research organization management. Manages clinical operational plan, and incorporates the study and scientific plan.

Biotech Beach (Santa Monica, California)

Astellas Pharma US
Clinical Research Specialist
Responsible for preparation, processing, review and filing of study documents. Assists the study team and CRO in study start-up activities including system set-up and study tracking. Processes and tracks site and vendor payments.

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