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News Breaks
April 25, 2014
11:02 EDTSNY, MRKEMA backs new indication for Sanofi's Gardasil, Merck's Silgard
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for Sanofi's (SNY) medicinal product Gardasil. The CHMP adopted a new indication of: "Gardasil is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions, premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus types and genital wartscausally related to specific HPV types." The CHMP also adopted a positive opinion recommending a variation to the terms of the marketing authorization for Merck Sharp & Dohme's (MRK) Silgard. The CHMP adopted a new indication of: "Silgard is a vaccine for use from the age of 9 years for the prevention of premalignant genital lesions, premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus types and genital warts causally related to specific HPV types."
News For SNY;MRK From The Last 14 Days
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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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13:26 EDTMRKMerck: KEYTRUDA showed superiority to chemotherapy for primary endpoint of PFS
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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, MRKCVS 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),
11:46 EDTMRKMerck management to meet with SunTrust
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November 13, 2014
07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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November 12, 2014
11:17 EDTMRKLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:13 EDTMRK, SNYBoston Biotech to hold a conference
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November 11, 2014
16:01 EDTMRKOptions Update; November 11, 2014
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15:43 EDTMRKLeerink major pharma & biotech analysts hold analyst/industry conference call
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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.
09:37 EDTMRKActive equity options trading
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08:10 EDTMRKMerck reports results from Phase 2 study of Grazoprevir/Elbasvir
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05:26 EDTSNYRegeneron, Sanofi announce dupilumab Phase 2b study met primary endpoint
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November 10, 2014
15:54 EDTSNYAmerican Society of Nephrology to hold a conference
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09:20 EDTMRKOn The Fly: Pre-market Movers
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08:48 EDTMRKGilead rises after Merck presents data on HCV combo
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07:20 EDTMRKGilead overhang from Merck HCV combo removed, says Wells Fargo
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November 9, 2014
18:58 EDTMRKMerck presents interim data from C-SWIFT study
Merck announced the presentation of interim data from the C-SWIFT study exploring the potential of a candidate triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir , the company’s investigational NS3/4A protease inhibitor and NS5A inhibitor, in combination with sofosbuvir, a nucleotide inhibitor for the treatment of chronic hepatitis C virus, HCV, infection. Preliminary findings in treatment-naïve HCV genotype 1- infected non-cirrhotic patients, following six and four weeks of treatment, and patients with cirrhotic disease, following eight and six weeks of treatment, will be presented by Dr. Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute, San Antonio, TX and C-SWIFT lead investigator. This poster presentation is part of a late-breaking abstract session at the 65th American Association for the Study of Liver Diseases, AASLD, Annual Meeting, also known as The Liver Meeting. “These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease, including cirrhotic patients,” said Dr. Lawitz. “These findings will inform the design of larger studies aimed at understanding the potential of short-duration triple therapy across multiple patient types.”
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