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News Breaks
December 14, 2012
07:31 EDTISIS, SNYGenzyme, Isis say CHMP adopts negative opinion on KYNAMRO MAA
Genzyme, a Sanofi company (SNY), and Isis Pharmaceuticals (ISIS), announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Genzyme plans to request a re-examination of the CHMP Opinion. An application for KYNAMRO is currently under review by the U.S. Food and Drug Administration. In October, KYNAMRO received a positive vote by an FDA advisory panel that Genzyme had provided sufficient efficacy and safety data to support the marketing of KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
News For SNY;ISIS From The Last 14 Days
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November 20, 2014
06:09 EDTSNYSanofi says has potential to launch up to six new drugs in 2015
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05:22 EDTSNYRegeneron, Sanofi receive FDA Breakthrough Therapy designation in AD
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November 19, 2014
08:17 EDTSNYRegeneron, Sanofi report new data from six alirocumab trials
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07:52 EDTSNYInforma Business Information to hold a conference
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07:11 EDTSNYSanofi drawing up list of CEO candidates to repalce Viehbacher, Reuters reports
Sanofi's (SNY) board is in the process of drawing up a short list of CEO candidates to replace Chris Viehbacher, sources tell Reuters. Jean-Rene Fourtou, a Sanofi director and the honorary chairman of media group Vivendi (VIVHY), has been selected to lead the appointments and governance committee that will select the next CEO. Smith & Nephew (SNN) CEO Olivier Bohuon, AstraZeneca (AZN) CEO Pascal Soriot and former Wyeth CEO Bernard Poussot have been rumored to be potential contenders for the CEO position. Reference Link
November 18, 2014
15:48 EDTISIS, SNYGenzyme, Isis present KYNAMRO data at AHA meeting
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that new two-year data from a phase 3 long-term extension study of KYNAMRO injection was presented at a scientific session at the annual American Heart Association meeting. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events compared to two years prior to therapy. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO.
12:16 EDTSNYSanofi to host seminar on New Medicines
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November 17, 2014
07:16 EDTSNYMilken Institute--Faster Cures to hold a conference
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
15:41 EDTISISIsis Pharmaceuticals management to meet with Piper Jaffray
Meeting to be held in Kansas City, MO on November 18 hosted by Piper Jaffray.
14:53 EDTSNYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
November 13, 2014
07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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05:34 EDTISISAstraZeneca, Isis Pharmaceuticals to co-develop oligonucleotide delivery methods
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November 12, 2014
08:13 EDTSNYBoston Biotech to hold a conference
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07:53 EDTISISLeerink to hold a tour
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November 11, 2014
10:14 EDTSNYRegeneron data reinforce blockbuster potential of dupilumab, says Piper Jaffray
Piper Jaffray believes the Phase IIb results for dupilumab in patients with moderate to severe asthma reported by Regeneron (REGN) and partner Sanofi (SNY) reinforce the broad potential of the drug in a range of allergic diseases. The firm reiterates its $416 price target and Overweight rating on shares of Regeneron.
05:26 EDTSNYRegeneron, Sanofi announce dupilumab Phase 2b study met primary endpoint
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November 10, 2014
16:07 EDTISISIsis Pharmaceuticals files to sell $425M in convertible senior notes due 2021
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15:54 EDTSNYAmerican Society of Nephrology to hold a conference
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