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May 13, 2014
04:55 EDTLLY, LLY, ARIA, ARIA, VSTM, VSTM, PFE, PFE, MRK, MRK, RXDX, RXDX, MACK, MACK, ONXX, ONXX, BAYRY, BAYRY, GSK, GSK, SNTA, SNTABoston Biotech Conference to hold a conference
Cancer Advance New York Conference is being held in New York on May 13-14.
News For SNTA;GSK;BAYRY;ONXX;MACK;RXDX;MRK;PFE;VSTM;ARIA;LLY From The Last 14 Days
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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.
15:12 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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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 BREO® ELLIPTA®), 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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12:48 EDTLLYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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11:36 EDTRXDXIgnyta price target raised to $17 from $14 at Leerink
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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.
March 17, 2015
19:42 EDTRXDXOn The Fly: After Hours Movers
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16:03 EDTRXDXIgnyta acquires 4 oncology R&D assets from Teva for 1.5M shares of common stock
Teva (TEVA) and Ignyta (RXDX) announced the acquisition by Ignyta of the worldwide rights and assets relating to four targeted oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7M shares at $10 per share, valuing the total offering at approximately $41.6M. Under the terms of the asset purchase agreement with Teva, Ignyta is acquiring all of Teva’s assets and worldwide rights relating to four oncology development programs in exchange for 1.5M shares of Ignyta’s common stock. Teva has agreed not to sell or otherwise transfer any of these shares until March 17, 2016, and Ignyta is required to register the resale of these shares with the SEC prior to such date. Ignyta also assumed all of Teva’s ongoing obligations under certain contracts relating to the purchased programs, including the agreements under which Teva in-licensed rights to the assets.
07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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March 16, 2015
15:33 EDTMRKMerck says study shows VYTORIN reduced CV events more than simvastatin alone
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07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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07:27 EDTLLYBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.
06:40 EDTPFEPCSK9 studies show potential improvement in heart health, WSJ says
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March 13, 2015
16:04 EDTMRKMerck provides update on investigational medicine sugammadex injection
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13:27 EDTARIAARIAD drug granted orphan designation as GIST treatment
ARIAD Pharmaceuticals' Iclusig was granted FDA orphan status on February 12 as a treatment of gastrointestinal stromal tumors, or GIST, according to a post to the agency's site. Reference Link
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