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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 16, 2014
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 EDTNVS, SNYCVS 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.
November 13, 2014
13:32 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
10:42 EDTBIIBSummer Street chief scientific officer holds an analyst/industry conference call
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07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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November 12, 2014
11:17 EDTNVSLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:18 EDTNVSUBS to hold a conference
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08:13 EDTSNY, BIIBBoston Biotech to hold a conference
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07:58 EDTNVSGenVec expects 2014 cash burn between $6M-$7M from Novartis collaboration
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November 11, 2014
16:14 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.
16:01 EDTNVSQIAGEN enters master collaboration agreement with Novartis
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15:43 EDTNVSLeerink 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.
05:26 EDTSNYRegeneron, Sanofi announce dupilumab Phase 2b study met primary endpoint
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November 10, 2014
16:07 EDTNVSUBS to hold a conference
UBS European Conference is being held in London, England on November 11-12.
15:57 EDTNVSWorldwide Business Research to hold a conference
ProcureCon for Digital & Marketing Services 2014 is being held in San Antonio on November 11-13.
15:54 EDTSNYAmerican Society of Nephrology to hold a conference
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