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Stock Market & Financial Investment News

News Breaks
June 26, 2014
04:55 EDTPFE, PFE, VRTX, VRTX, BAYRY, BAYRY, CBST, CBST, IRWD, IRWD, AMGN, AMGN, SHPG, SHPG, GSK, GSK, CELG, CELG, BMY, BMY, LLY, LLYQ1 Productions to hold a conference
Customer Centric Medical Information Conference to be held in Boston on June 26-27.
News For PFE;BMY;CELG;GSK;SHPG;AMGN;IRWD;CBST;BAYRY;VRTX;LLY From The Last 14 Days
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March 20, 2015
08:12 EDTSHPGShire upgraded to Outperform from Market Perform at Bernstein
Bernstein upgraded Shire as the firm thinks that the stock's risk/reward ratio is positive following several new developments. Among these developments are the firm's belief that the company's orphan drug strategy looks increasingly strong, while the risks to the company's Vyvanse and mesalamines drugs look to have moderated and the company has several near-term, 2015 catalysts. Target $295.
08:01 EDTLLYEli Lilly and Innovent Biologics announce strategic alliance
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07:55 EDTPFE, BMYAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTPFE, LLY, AMGN, CELG, BAYRYAmerican Academy of Dermatology to hold annual meeting
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06:26 EDTCELGCelgene price target raised to $144 from $135 at Piper Jaffray
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March 19, 2015
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
15:55 EDTAMGNAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTAMGNAmgen denied preliminary injunction for biologics against Novartis, Reuters says
15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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11:00 EDTPFEPfizer participates in a conference call with Bernstein
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09:37 EDTCELGActive equity options trading on open
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08:08 EDTLLYEli Lilly and Hanmi sign license and collaboration agreement
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07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREOŽ ELLIPTAŽ), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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17:07 EDTCELGCelgene GED-0301 Phase II data published in New England Journal of Medicine
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12:48 EDTLLYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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08:03 EDTSHPGTherapeuticsMD names Angus Russell, J. Martin Carroll as directors
TherapeuticsMD (TXMD) announced the appointment of two biopharmaceutical senior executives, Angus C. Russell and J. Martin Carroll, as independent members of its board of directors, and that Randall S. Stanicky has stepped down from the board of directors. Angus C. Russell served as CEO of Shire PLC (SHPG) from June 2008 until April 2013. J. Martin Carroll served as president and CEO of Boehringer Ingelheim Corp. U.S. from 2003 until 2011.
07:46 EDTLLYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
07:22 EDTSHPGShire looking for 'transformational' deal, Betaville blog says
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