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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.
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August 20, 2014
08:30 EDTGSKPernix closes acquisition of Treximet
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08:29 EDTGSKPernix Therapeutics to host conference call
Conference call to discuss acquisition of Treximet will be held on August 20 at 9 am. Webcast Link
08:04 EDTGSKPOZEN announces U.S. rights for Treximet acquired by Pernix Therapeutics
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08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 18, 2014
11:41 EDTPFECubist rises after report sparks takeover interest speculation
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08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
06:34 EDTGSKLawyer says GSK connected investigators to not appeal ruling, Reuters says
Defense lawyer Zhai Jian said GlaxoSmithKline connected corporate investigator Peter Humphrey and his American wife are not aiming to appeal a Chinese court's prison sentence ruling, according to Reuters, citing comments from Jian. Reference Link
August 14, 2014
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
August 13, 2014
16:19 EDTGSKOn The Fly: Closing Wrap
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13:13 EDTGSKInterMune exploring sale after bids from Sanofi, Roche, Glaxo, Bloomberg says
InterMune (ITMN) is working with its financial advisers Goldman Sachs (GS) and Centerview Partners to evaluate takeover bids it has received from Sanofi (SNY), Roche (RHHBY), GlaxoSmithKline (GSK) and Actelion (ALIOF), said Bloomberg, citing people with knowledge of the matter. The report noted that one of the sources said Sanofi has so far shown the most interest in a deal for InterMune, whose shares are up more than 13% to $51.56 following the first headlines from the report. Reference Link
August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
07:15 EDTGSKWHO says ethical to offer unproven interventions in light of Ebola outbreak
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06:18 EDTGSKGSK CEO faces pressure as company deals with weak sales, allegations, WSJ says
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August 11, 2014
12:57 EDTGSKGlaxoSmithKline facing new bribery allegations in Syria, Reuters reports
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08:47 EDTGSKGlaxo to conduct Ebola vaccine trials later this year, Guardian says
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August 8, 2014
09:03 EDTGSKGlaxoSmithKline weakness creates buying opportunity, says Argus
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06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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06:18 EDTGSKRoyal Bank of Scotland's Hampton leads race to become new GSK chair, FT reports
Royal Bank of Scotland (RBS) Chairman Philip Hampton is the frontrunner to succeed Christopher Gent as chairman of GlaxoSmithKline (GSK), the Financial Times reports, citing sources. Gent will step down from his role at GSK next year. Hampton is not expected to step down from RBS until after May's general election, the sources say. Reference Link
August 7, 2014
08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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