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Stock Market & Financial Investment News

News Breaks
March 28, 2014
05:46 EDTSHPG, ARIA, GSK, LLY, JAZZRumors suggest Jazz looking to buy ARIAD, Daily Mail reports
Rumors suggest that Jazz Pharmaceuticals (JAZZ) is willing to pay $20-plus per share to acquire ARIAD (ARIA), Daily Mail says in its Market Report. GlaxoSmithKline (GSK), Shire (SHPG) and Eli Lilly (LLY) are rumored to have lost out on the auction for ARIAD, the paper adds. Reference Link
News For ARIA;JAZZ;GSK;SHPG;LLY From The Last 14 Days
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March 20, 2015
09:47 EDTGSKGlaxoSmithKline, Theravance launch Revlar Ellipta in Italy
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Revlar Ellipta in Italy following the recent approval by the Italian regulatory authorities in December 2014. Relvar is a fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. The components will be administered using the Ellipta, a dry powder inhaler. In Italy, the product is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product is appropriate; and for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease with a FEV1<70% predicted normal post-bronchodilator with an exacerbation history despite regular bronchodilator therapy.
09:41 EDTSHPGBernstein global specialty pharma analyst holds analyst/industry conference call
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09:01 EDTLLYEli Lilly up 2% to $75.75 in pre-market trading
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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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07:41 EDTLLYAmerican Academy of Dermatology to hold annual meeting
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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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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
13:05 EDTJAZZJazz Pharmaceuticals management to meet with Piper Jaffray
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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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March 17, 2015
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
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.
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