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March 28, 2014
08:01 EDTRHHBY, HALOHalozyme announces Roche marketing authorization for MabThera SC
Halozyme (HALO) announced that the European Commission has approved Roche's (RHHBY) new subcutaneous formulation of MabThera for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Following the approval of Herceptin SC in September 2013, this is the second European approval for a novel subcutaneous formulation of one of Roche's oncology products using Halozyme's patented Enhanze technology. The European approval was primarily based on data from the pivotal SABRINA study, which was recently published in the Lancet Oncology. Roche has stated that they expect to begin launching MabThera SC in a number of European markets throughout 2014.
News For HALO;RHHBY From The Last 14 Days
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October 10, 2015
16:45 EDTRHHBYRoche to hold an investor update conference call
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October 9, 2015
08:21 EDTRHHBYRoche to acquire Adheron Therapeutics
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October 8, 2015
11:57 EDTRHHBYRoche says ocrelizumab cuts disability progression in studies of two forms of MS
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October 6, 2015
13:32 EDTRHHBYBiotechs 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).
05:22 EDTRHHBYExelixis reports phase 3 pivotal trial of cobimetinib met secondary endpoint
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October 4, 2015
14:39 EDTRHHBYPTC presents Phase 2 data on RG7800 for spinal muscular atrophy
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September 30, 2015
17:48 EDTRHHBYPacific Biosciences launches new sequencing platform
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