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March 7, 2014
14:18 EDTRHHBY, AMGN, NVS, SNY, PFE, REGNConcerns with PCSK9 class not seen with Regeneron drug, says Citigroup
Citigroup said its talks with Regeneron (REGN) indicate that the issues the FDA has noted with PCSK9 drugs have not arisen in the ongoing Phase 3 studies of Regeneron and Sanofi's (SNY) Alirocumab. Citi suspects the events described in filings by Regeneron and Sanofi might have been seen with PCSK9 inhibitors being developed by Amgen (AMGN), Pfizer (PFE), Novartis (NVS) or Roche (RHHBY). Citi also notes that neurocognitive side effects are known to be caused by statins and it is unclear whether the effects were seen with PCSK9 inhibitors when used alone or when combined with statins.
News For REGN;SNY;AMGN;PFE;NVS;RHHBY From The Last 14 Days
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November 17, 2014
08:13 EDTPFEPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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07:16 EDTPFE, SNYMilken Institute--Faster Cures to hold a conference
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06:43 EDTPFEAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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05:30 EDTRHHBYInovio, Roche terminate collaboration for INO-5150
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05:27 EDTPFEPfizer lowers FY14 Reported EPS view to $1.40-$1.49 from $1.50-$1.59
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05:23 EDTPFEPfizer forms strategic alliance with Merck KGaA
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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
16:58 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Alibaba (BABA), eBay (EBAY), Bed Bath & Beyond (BBBY), Shire (SHPG), and Parker Hannifin (PH). INCREASED STAKES: Actavis (ACT), Amgen (AMGN), EQT (EQT), Sensata (ST), Coca-Cola Enterprises (CCE). DECREASED STAKES: Williams Cos (WMB), Ally Financial (ALLY), Cheniere Energy (LNG), YPF (YPF), and FedEx (FDX). LIQUIDATED STAKES: AIG (AIG), T-Mobile (TMUS), Rackspace (RAX), Hertz (HTZ), and Citrix Systems (CTXS).
14:53 EDTNVS, SNY, RHHBY, PFECVS 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),
13:27 EDTRHHBYRoche reports FDA nod for Avastin in platinum-resistant recurrent ovarian cancer
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09:38 EDTAMGNJANA Partners gives quarterly update on stakes
NEW STAKES: AMD (AMD), AECOM Technology (ACM), Alibaba (BABA), McDonald's (MCD), Amgen (AMGN), Gaming and Leisure Properties (GLPI), Iron Mountain (IRM), iRobot (IRBT), Seadrill Partners (SDLP), Valeant (VRX). INCREASED STAKES: eBay (EBAY), Charter (CHTR), Groupon (GRPN), HD Supply (HDS), Hertz (HTZ). DECREASED STAKES: Apache (APA). LIQUIDATED STAKES: CBS (CBS), Endo (ENDP), FMC Corporation (FMC), SeaWorld (SEAS), SunEdison (SUNE).
09:37 EDTAMGNJANA reports new stakes in McDonald's, AECOM, Amgen
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07:14 EDTAMGN, NVS, PFEAmerican 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.
07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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07:38 EDTPFEBloomberg Link to hold a conference
The Year Ahead: 2015 is being held in Washington, D.C. with a pre-conference dinner on November 13 followed by company presentations on November 14,
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