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April 23, 2014
04:55 EDTDNA, DNA, DNA, AMGN, AMGN, AMGN, PFE, PFE, PFE, BIO, BIO, BIO, BIIB, BIIB, BIIB, MRK, MRK, MRK, ASTX, ASTX, ASTX, SNY, SNY, SNY, GSK, GSK, GSKCambridge Healthtech Institute to hold a conference
9th Annual Drug Discovery Chemistry Conference is being held in San Diego, CA on April 23-25.
News For DNA;AMGN;PFE;BIO;BIIB;MRK;ASTX;SNY;GSK From The Last 14 Days
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October 20, 2014
10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the productís U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
08:06 EDTSNY, MRKMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:34 EDTMRKAdvaxis names Mauro Chief Medical Officer
Advaxis (ADXS) announced that it has appointed David Mauro, as executive vice president, Chief Medical Officer Mauro most recently served as executive director, section head oncology clinical development at Merck (MRK). In connection with his appointment, Mauro received a one-time inducement award of 165K restricted shares, of which 55K are fully vested and as of the grant date. The remaining shares vest annually over a two-year period.
07:32 EDTBIIBCubist names Perez CEO to succeed Bonney
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07:19 EDTSNY, MRK, GSK, AMGNIBC Life Sciences to hold a conference
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07:16 EDTDNAAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
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 EDTMRK, PFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFE, BIO, SNYAmerican Society of Human Genetics to hold annual meeting
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07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
October 19, 2014
15:56 EDTAMGNAmgen to aid in production method for Ebola drug ZMapp, Bloomberg says
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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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09:06 EDTAMGN, SNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
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