FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications
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- Category: AstraZeneca
On 8 April 2009, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalised anxiety disorder (GAD).
Genzyme to acquire the worldwide rights to Campath® (alemtuzumab) from Bayer HealthCare
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- Category: Genzyme
Genzyme Corporation (Nasdaq: GENZ) has entered into an agreement to acquire the worldwide rights to Campath® (alemtuzumab) from Bayer HealthCare, giving Genzyme primary responsibility for the development and commercialization of this potential break-though treatment for multiple sclerosis (MS). Bayer will continue to fund a portion of alemtuzumab's development in MS and will retain an option to co-promote the product in MS upon approval.
The First Pharmaceutical Company for Protection of Human Rights in Clinical Research
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- Category: Pfizer
Pfizer Inc announced has become the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) for ensuring the protection of human subjects taking part in early-stage clinical trials.
Pfizer Development Pipeline Shows Advances In High-Priority Disease Areas
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- Category: Pfizer
Pfizer Inc has provided an update to its pipeline, highlighting the progression of clinical programs in high-priority therapeutic areas, and announced the start of Phase 3 clinical trials for two new molecular entities. In total, the company initiated seven Phase 3 programs within the past six months.
GSK submits Tyverb®/Tykerb® for first-line treatment of metastatic breast cancer in Europe, US
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) has announced the submission of two simultaneous regulatory applications to expand the use of Tyverb®/Tykerb® (lapatinib). If authorised, lapatinib could be used as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic (or advanced) breast cancer in Europe and the United States.
Significantly More Patients With Cardiovascular Disease Quit Smoking Using Chantix/Champix®
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- Category: Pfizer
Pfizer Inc announced the results of a study that found that 47 percent of smokers with a history of cardiovascular disease who took CHANTIX/CHAMPIX® (varenicline) were able to quit smoking and remain abstinent during the last four weeks of treatment (weeks 9-12) compared with just 13.9 percent of those given placebo. These findings were presented today at the American College of Cardiology 58th Annual Scientific Session in Orlando, Fla.
Bayer Crop Science and the French research organization CNRS intensify collaboration
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- Category: Bayer
Bayer CropScience and the National Centre for Scientific Research (Centre National de la Recherche Scientifique, CNRS) in Paris, France, have renewed a framework agreement signed in 2005. The new, joint research projects pursued under this agreement are intended to contribute to ensuring a sustainable food supply for a growing world population in the context of climate change.
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