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News Breaks
November 8, 2013
06:16 EDTINCY, SNY, GERNIncyte still well positioned in myelofibrosis, says Jefferies
Jefferies believes Incyte (INCY) remains well positioned in myelofibrosis following data abstracts on two competitors. The firm says Geron's (GERN) data for imetelstat looks promising but comes with caveats, while Incyte's Jakafi is a strong competitor to Sanofi's (SNY) fedratinib. Jefferies keeps a Buy rating on shares of Incyte.
News For INCY;GERN;SNY From The Last 14 Days
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November 18, 2014
12:16 EDTSNYSanofi to host seminar on New Medicines
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November 17, 2014
11:06 EDTGERN, INCYLeerink 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
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
16:21 EDTGERNOn The Fly: Closing Wrap
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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),
12:58 EDTGERNOn The Fly: Midday Wrap
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12:48 EDTGERNGeron November volatility up on strategic collaboration with Janssen Biotech
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10:00 EDTGERNOn The Fly: Analyst Upgrade Summary
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09:16 EDTGERNOn The Fly: Pre-market Movers
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07:12 EDTGERNGeron upgraded to Overweight from Neutral at Piper Jaffray
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November 13, 2014
18:40 EDTGERNOn The Fly: After Hours Movers
UP AFTER EARNINGS: TubeMogul (TUBE), up 12.4%... Weibo (WB), up 3.2%... Nordstrom (JWN), up 3.1%. ALSO HIGHER: Geron (GERN), up 30.7% after announcing a global strategic collaboration with Janssen Biotech... Baker Hughes (BHI), up 16.2% following reports that the company is in talks to be acquired by Halliburton (HAL)... Halliburton is up 1.4%... Pandora (P), up 4% after announcing a conference call to discuss Web IV proceeding... AmerisourceBergen (ABC), up 1.1% after being awarded a $4.06B government contract. DOWN AFTER EARNINGS: Retrophin (RTRX), down 6.6%... Phoenix New Media (FENG), down 8.4%... Voxeljet AG (VJET), down 8.6%... Intrexon (XON), down 1.1%... Youku Tudou (YOKU), down 5.7%... Applied Materials (AMAT), down 2.5%. ALSO LOWER: Puma Biotechnology (PBYI), down 6.9% following PB272 Phase II Trial results... EnLink Midstream (ENLK), down 4.8% after filing to sell 10.5M common units representing limited partners.
16:28 EDTGERNGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
13:32 EDTGERN, INCYLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTGERN, INCYLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTINCY, GERNLeerink 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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November 12, 2014
11:17 EDTINCYLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:13 EDTSNYBoston Biotech to hold a conference
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