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News For SNY;JNJ;PFE;SHPG;AGN;MRK;OREX;VPHM;NVO;AMGN;INFI;SGEN From The Last 14 Days
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August 21, 2015
09:01 EDTJNJLeerink medical devices analyst holds an analyst/industry conference call
Medical Device Analyst Newitter, along with MEDACorp Specialists Dorance Dillon and Terence Farrell, discuss the Centers for Medicare & Medicaid Services' recently proposed "Comprehensive Care For Joint Replacement Payment Model" and how this model might influence ortho pricing and hospital-vendor relationships on an Analyst/Industry conference call to be held on August 24 at 1 pm.
08:01 EDTPFEPfizer says two Phase 3 Trumenba studies met primary endpoints
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05:44 EDTMRKStocks with implied volatility movement; DIS MRK
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August 20, 2015
11:33 EDTJNJ, SNY, NVO, MRKLeerink major pharmaceuticals analyst holds an analyst/industry conference call
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11:24 EDTPFEPfizer says Ibrance application validated by EMA
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08:38 EDTMRKMerck says to present new analyses from IMPROVE-IT study
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08:16 EDTAGNAllergan's Botox resubmission for lower limb spasticiy accepted by FDA
Allergan 's resubmission of its Supplemental Biologics License Application for Botox for the treatment of adults with lower limb spasticity in adults has been accepted by the FDA. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act date is expected to be in 1Q16. The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity. The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
August 18, 2015
12:13 EDTMRKMerck recalls Temodar, Temozolomide bottles with cracked caps
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12:06 EDTAMGNAmgen to pay $71M in 48-state settlement over Aranesp, Enbrel promotions
West Virginia Attorney General Patrick Morrisey announced his Office has participated in a $71M multi-state settlement with Amgen to resolve allegations it unlawfully promoted the biologic medications Aranesp and Enbrel. West Virginia will receive $845,637.82 as part of the settlement, which was negotiated between the company and Attorneys General from 48 states and the District of Columbia. A complaint in the matter was filed Tuesday morning in Kanawha County Circuit Court. Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells. Enbrel is used to treat a number of conditions, including plaque psoriasis. In addition to the $71M settlement, the agreement requires Amgen to reform its marketing and promotional practices. In addition to West Virginia, the other states participating in this settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming and the District of Columbia.
09:19 EDTAMGNPiper Jaffray biopharma analyst holds an analyst/industry conference call
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09:07 EDTAMGNAmgen and University of California announce education program partnership
Amgen and the Center for Social Sector Leadership at the University of California, or UC, Berkeley's Haas School of Business announced a multi-year partnership to offer a graduate-level course on measuring outcomes of cancer patient advocacy education and support programs. The MBA course, Social Impact Metrics, is designed to advance the ability of nonprofit organizations to measure the effectiveness of their programs, which is critical in an increasingly challenging donor environment. The overall goal of the initiative is to create a set of measurement best practices that can be adopted across the cancer nonprofit community and beyond.
08:03 EDTMRKMerck says FDA accepts sBLA for Keytruda
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06:23 EDTSGENSeattle Genetics approvals already factored into forecast, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff believes the FDA approval for Adcetris in post-transplant consolidation Hodgkin's Lymphoma as well as the "positive surprise" of the FDA converting the accelerated approval in relapsed HL to standard approval is already factored into in his sales forecast of $220M this year for the drug. He keeps an Underweight rating on Seattle Genetics with a $30 price target.
August 17, 2015
19:00 EDTSGENOn The Fly: After Hours Movers
UP AFTER EARNINGS: Fabrinet (FN), up 5.1%. ALSO HIGHER: Esperion Therapeutics (ESPR), up 10.6% after announcing that it is on track to initiate ETC-1002 Phase 3 program by the end of 2015... Seattle Genetics (SGEN), up 3.3% after announcing FDA approval of Adcetris for HL treatment. DOWN AFTER EARNINGS: MasTec (MTZ), down 7.4%... Urban Outfitters (URBN), down 2.3%. ALSO LOWER: Sunedison (SUNE), down 1% after announcing a $500M perpetual convertible preferred stock offering.
16:14 EDTSGENSeattle Genetics announces FDA approval of Adcetris for HL treatment
Seattle Genetics announced that the U.S. Food and Drug Administration has approved ADCETRIS, brentuximab vedotin, for the treatment of patients with classical Hodgkin lymphoma, HL, at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation consolidation. The approval is based on a phase 3 clinical trial called AETHERA that was designed to compare up to 16 cycles of ADCETRIS therapy administered every three weeks following auto-HSCT to placebo. The primary endpoint was met with a significant improvement in median progression-free survival of 42.9 months for patients who received ADCETRIS versus 24.1 months for patients who received placebo, an improvement of 18.8 months. In addition, data from the AETHERA trial converted the U.S. accelerated approval of the relapsed classical HL indication to regular approval. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma, as well as other lymphoma subtypes. This is the third indication for ADCETRIS, which was granted accelerated FDA approval in August 2011 for two other indications: (1) treatment of Hodgkin lymphoma patients who fail autologous transplant or who fail at least two prior multi-agent chemotherapy regimens and are not autologous transplant candidates, and (2) treatment of systemic ALCL patients who fail at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
08:23 EDTAMGNDeutsche Bank biotech analyst holds an analyst/industry conference call
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06:55 EDTSHPGBaxalta initiated with an Outperform at William Blair
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06:48 EDTSHPGShire to raise Baxalta offer if given access to company's books, Telegraph says
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06:22 EDTSGENPiper's Tenthoff sees select biotech names outperforming in second half
Piper Jaffray analyst Edward Tenthoff expects drug launches, clinical data read-outs and potential partnerships to drive outperformance for select biotech names in the second half of 2015. Despite some recent profit-taking, 2015 has been another strong year for biotech stocks, Tenthoff tells investors in a research note. Names with important second half of the year catalysts include Vertex (VRTX), Regeneron (REGN), Seattle Genetics (SGEN), Exelixis (EXEL), Sarepta (SRPT), Novavax (NVAX), Arrowhead (ARWR), Array BioPharma (ARRY), Alnylam (ALNY), Genocea (GNCA), CymaBay (CBAY), Idera Pharmaceuticals (IDRA), Vitae Pharmaceuticals (VTAE).
August 16, 2015
15:03 EDTSHPGShire must raise bid to $35B to interest Baxalta, Sunday Times says
Shire (SHPG) will have to increase its bid for Baxalta (BXLT) by about $5B to $35B in order to entice the company's board, reports the Sunday Times, citing people working on the deal. Even a $35B deal would only be a starting point, cautioned the sources. Reference Link
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