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February 15, 2013
10:21 EDTGSK, PFEViiV Healthcare granted FDA priority review for dolutegravir
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK) and Pfizer (PFE), announced that the U.S. Food and Drug Administration has granted a priority review designation to dolutegravir submitted for the treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents. The FDA has assigned dolutegravir a Prescription Drug User Fee Act target date of August 17, 2013. ViiV Healthcare submitted a Marketing Authorisation Application for dolutegravir to the European Medicines Agency on December 17, 2012.
News For GSK;PFE From The Last 14 Days
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October 20, 2014
07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:19 EDTGSKIBC Life Sciences to hold a conference
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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14:50 EDTGSKBARDA asks labs to ramp up Zmapp production, Reuters says
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11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
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October 16, 2014
08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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October 15, 2014
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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October 14, 2014
13:09 EDTGSKGlaxoSmithKline seeks binding bids for mature drugs, Reuters reports
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11:23 EDTGSK, PFEBIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTGSKNIH says several potential Ebola treatments under development
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10:10 EDTGSKNIH director says supporting BioCryst, Chimerix Ebola treatments
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October 13, 2014
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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07:12 EDTGSKOligonucleotide Therapeutics Society to hold annual meeting
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