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News Breaks
March 25, 2013
07:53 EDTTEVA, NVS, SNY, BIIBRuling on Sanofi MS drug may have implications for Teva, Biogen, Reuters says
Sanofi's (SNY) new multiple sclerosis pill Aubagio won an EU approval recommendation, but the European Medicines Agency refused to give it a "new active substance" designation because it is too similar to an older drug, meaning generic copies could be launched in Europe in as little as three years, reported Reuters, citing a Bernstein analyst. The analyst added that such generics could "wreak havoc" on the rest of the European MS market and could impact drugs from Teva (TEVA), Biogen Idec (BIIB) and Novartis (NVS). Reference Link
News For SNY;TEVA;BIIB;NVS 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 EDTBIIB, SNYInforma Business Information to hold a conference
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07:21 EDTBIIBBiogen price target lowered to $400 from $425 at Credit Suisse
Credit Suisse lowered Biogen's price target to $400 from $425 based on Gilenya PPMS risk but retains its Outperform rating based on the quality of earnings growth and pipeline.
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 EDTSNYGenzyme, 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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11:22 EDTTEVATeva patent victory over Warner Chilcott, Roche affirmed
The U.S. Court of Appeals for the Federal Circuit ruled that a district court was correct to grant summary judgment to Teva (TEVA) in a patent dispute with Warner Chilcott and Roche (RHHBY) over patents related to osteoporosis drug risedronate.
10:08 EDTTEVATeva calls active on renewed takeover chatter
Teva November 57 and 58 calls are active on total call volume of 21K contracts (2K puts) following renewed takeover chatter. November call option implied volatility is at 18, December is at 19; compared to its 26-week average of 24 according to Track Data. Active call volume suggests traders taking positions for upside price movement.
09:47 EDTTEVARumor: Teva moves up on renewed takeover chatter
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08:00 EDTTEVATeva launches liquid formulation of TREANDA injection in the U.S.
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November 17, 2014
16:52 EDTNVSNovartis' LCZ696 could change course of heart failure for patients, study shows
New data on Novartis' investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction shows it has the potential to change the course of the disease for patients. In August, Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. The new analyses being presented for the first time at the American Heart Association Scientific Sessions 2014, with a paper being simultaneously published in Circulation, show that versus enalapril, LCZ696 significantly: reduced the risk of dying suddenly by 20% in HFrEF patients 45% of CV deaths and 36% of all cause deaths are sudden; reduced first and subsequent HFrEF hospitalizations by 21% and 23% respectively; reduced hospitalizations for a cardiovascular reason or for any reason both by 16%; reduced the need for more intense treatment at home by 16%; reduced emergency room visits because of rapid symptom worsening by 30%.
11:06 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
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07:16 EDTSNYMilken Institute--Faster Cures to hold a conference
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November 16, 2014
15:07 EDTNVSNovartis says arthritis drug secukinumab met primary endpoint
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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
14:53 EDTSNY, NVSCVS 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),
07:14 EDTNVSAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
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