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April 7, 2014
05:48 EDTMYGN, AZNMyriad Genetics submits premarket approval to FDA for BRACAnalysis
Myriad Genetics (MYGN) announced that it has submitted the first module of a premarket approval, or PMA, application to the FDA for the use of BRACAnalysis testing as a companion diagnostic with olaparib. Olaparib is an investigational, orally active poly-ADP ribose polymerase, or PARP, inhibitor being developed by AstraZeneca (AZN).
News For MYGN;AZN From The Last 14 Days
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October 7, 2015
07:07 EDTMYGNMyriad Genetics, Tufts Health Plan sign agreement to cover Prolaris
Myriad Genetics announced that it has signed a three-year contract with Tufts Health Plan through which the plan will provide coverage of Prolaris for members diagnosed with localized prostate cancer. Prolaris is the first and only biopsy test validated against prostate cancer specific mortality. Tufts Health Plan is a leading health plan in the Northeast with more than one million members. Tufts Health Plan's members will benefit from this agreement, which is designed to drive optimal treatment because men can confidently pursue active surveillance for tumors identified as being less aggressive with Myriad's extensively validated Prolaris combined score. Recent data show that many men realize no benefit from interventional treatment, and many suffer needlessly from the side effects associated with radical prostatectomy and radiation.
October 6, 2015
13:32 EDTAZNBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space 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).
07:23 EDTMYGNAmerican Society of Human Genetics to hold annual meeting
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October 1, 2015
07:31 EDTAZNLeerink to hold a roundtable
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September 30, 2015
08:02 EDTAZNAstraZeneca says SYMBICORT results published in journal
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September 29, 2015
08:07 EDTAZNAstraZeneca says Brilinta 60-mg tablets now available in U.S. pharmacies
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September 28, 2015
07:52 EDTAZNIIR Holdings to hold a conference
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September 25, 2015
07:22 EDTAZN, MYGNEuropean Society for Medical Oncology to hold a conference
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