FDA Classifies Prolia(TM) (Denosumab) Complete Response Submission and Targets Action Date
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- Category: Amgen
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission.
Lilly, Merck, And Pfizer Announce the Formation of the Asian Cancer Research Group, Inc.
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- Category: Pfizer
Eli Lilly and Company, Merck (also known as Merck Sharp & Dohme (MSD) outside the USA and Canada), and Pfizer Inc. announced the formation of the Asian Cancer Research Group, Inc., (ACRG), an independent, not-for-profit company established to accelerate research and ultimately improve treatment for patients affected with the most commonly-diagnosed cancers in Asia.
Novartis receives FDA approval of Menveo®
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- Category: Novartis
Novartis announced that Menveo®, a quadrivalent meningococcal conjugate vaccine was approved by the US Food and Drug Administration (FDA) for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age[1].
US FDA approves Rituxan/MabThera for the most common type of adult leukemia
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) approved Rituxan/MabThera (rituximab) plus fludarabine and cyclophosphamide (FC) chemotherapy for people with either previously untreated (first-line) or previously treated (relapsed or refractory) CD20-positive chronic lymphocytic leukemia (CLL).
GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia
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- Category: GlaxoSmithKline
The Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone) that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug.
GSK rejects conclusions reported in The New York Times story on Avandia
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) rejects the conclusions about the safety of Avandia (rosiglitazone) reported in the February 20, 2010, New York Times story.
GlaxoSmithKline and XenoPort receive FDA Complete Response letter for Horizantâ¢
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- Category: GlaxoSmithKline
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).
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