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News Breaks
February 3, 2013
14:25 EDTMDT, BMY, AZN, RHHBY, STJ, MRK, PFE, GSK, BSX, LLY, SNY, JNJDrug, medical device makers must disclose doctor payments, Bloomberg says
Payments from drugmakers and medical device companies to doctors must be disclosed to the U.S. government beginning next March, says Bloomberg. Reference Link
News For RHHBY;JNJ;GSK;AZN;SNY;PFE;BMY;LLY;MRK;MDT;BSX;STJ From The Last 14 Days
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March 19, 2015
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.
07:02 EDTRHHBYSigma-Aldrich signs exclusive distribution agreement with Roche
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05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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12:48 EDTLLY, RHHBYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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10:00 EDTSTJOn The Fly: Analyst Downgrade Summary
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09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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07:46 EDTLLY, RHHBYLilly 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.
05:39 EDTMDT, BSX, STJSt. Jude Medical downgraded to Market Perform from Outperform at Wells Fargo
Wells Fargo downgraded St. Jude Medical (STJ) to Market Perform saying competitive pressures will drive 2015 market share losses in the company's cardiac rhythm management business, which represents 50% of total sales. Wells believes the launch of CardioMEMS will not be strong enough to offset the headwinds in CRM unit. The firm thinks Boston Scientific's (BSX) earlier than expected approval for its next generation subcutaneous implantable cardioverter-defibrillator called Emblem will drive share gains against St. Jude and Medtronic (MDT) in the single chamber ICD market. Wells cut its price target range for St. Jude shares to $69-$70 from $73-$74. The medical technology company closed yesterday down $2.01 to $65.45.
March 17, 2015
16:13 EDTBSXBoston Scientific announces FDA, CE Mark approval of EMBLEM S-ICD system
Boston Scientific has received FDA and CE Mark approval of the EMBLEM Subcutaneous Implantable Defibrillator, or S-ICD, system. The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest, yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators. A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May and subsequent U.S. launch planned for the third quarter of 2015.
14:10 EDTAZNIGI Laboratories recent sell-off a buying opportunity, says Craig-Hallum
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10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
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
05:35 EDTJNJJohnson & Johnson to invest $10M in UK government fund to fight dementia
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