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Stock Market & Financial Investment News

News Breaks
August 6, 2014
07:02 EDTGSK, SNTA, SNYSynta Pharmaceuticals names Anne Whitaker as CEO, effective September 2
Synta Pharmaceuticals (SNTA) announced that Anne Whitaker will join the Company as President, CEO and a member of the Company’s Board of Directors effective September 2, 2014. Ms. Whitaker has more than 20 years of experience in the pharmaceutical industry, principally at GlaxoSmithKline (GSK) and Sanofi (SNY) including, most recently, the role of President, North America Pharmaceuticals, at Sanofi.
News For SNTA;GSK;SNY 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.
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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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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07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
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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05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
March 16, 2015
08:23 EDTSNYPCSK9 data continues to impress, says Leerink
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07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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07:16 EDTSNYRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTSNYPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
13:04 EDTSNYSanofi, Regeneron announce publication of results of ODYSSEY long term trial
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) today announced that 18-month results of a Phase 3 trial of Praluent, alirocumab, an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol by an additional 62% at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks."These results demonstrated the durable efficacy for Praluent when added to maximally-tolerated statin therapy and further reinforce its generally consistent safety profile," said Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent -- we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events."
March 13, 2015
10:37 EDTSNYSanofi says NHS England de-lists cabazitaxel, aflibercept
Sanofi announcd that NHS England has confirmed that it is de-listing both cabazitaxel and aflibercept from the Cancer Drugs Fund, so that neither of these medicines will be available to new patients in England on the NHS. It added, "However regarding cabazitaxel NHS England have agreed to engage in talks to explore immediate ways of maintaining access to patients until it is reviewed by NICE." Tarja Stenvall, General Manager for Sanofi in the UK, commented, "We are hugely disappointed that cabazitaxel and aflibercept have been cut from the CDF and that new patients in England will no longer have access to these crucial cancer treatments. However NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review. Our concern is for patients who should continue to have access to cabazitaxel until a longer term solution is reached and who may feel confused and uncertain until this happens."
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