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News Breaks
January 24, 2014
11:35 EDTHALO, RHHBYHalozyme announces positive CHMP opinion on Roche's MabThera SC
Halozyme Therapeutics (HALO) announced that the EU Committee for Medicinal Products for Human Use, or CHMP, has recommended that the European Commission approve Roche's (RHHBY) subcutaneous formulation of MabThera using Halozyme's recombinant human hyaluronidase for the treatment of patients with common forms of non-Hodgkin lymphoma. The CHMP opinion is based primarily on data from Roche's Phase 3 SABRINA study. Roche expects a final decision from the European Commission in the coming months, Halozyme said. In 2006, Halozyme entered into an agreement with Roche and to date, Roche has elected to explore the use of rHuPH20 for up to a total of five exclusive targets, and Roche retains the option to apply rHuPH20 to three additional targets through the payment of annual license maintenance fees. Subject to the successful achievement of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on product sales for Herceptin SC, MabThera SC and any other product candidates which would be successfully developed and commercialized under the agreement.
News For HALO;RHHBY From The Last 14 Days
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January 29, 2015
12:00 EDTRHHBYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analyst Schwartz discusses Biogen Idec BIIB037 and whether 2015 will be the year when Amyloid Beta is finally validated as a disease-modifying target in Alzheimer's Disease on an Analyst/Industry conference call to be held on February 3 at 2 pm.
09:21 EDTHALOIridian Asset reports 9% passive stake in Halozyme
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05:47 EDTRHHBYRoche, Qualcomm collaborate on remote patient monitoring
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January 28, 2015
08:07 EDTRHHBYRoche unit receives orphan status for alectinib
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05:49 EDTRHHBYRoche sees 2015 sales growth in low- to mid-single digit
Roche expects sales to grow low- to mid-single digit, at constant exchange rates for 2015. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:48 EDTRHHBYRoche reports 2014 core EPS CHF14.29 vs. CHF14.27 last year
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January 27, 2015
14:00 EDTRHHBYRoche to hold a meeting with a conference call hookup
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January 26, 2015
05:15 EDTRHHBYRoche receives FDA clearance for next generation cobas MRSA/SA test
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January 23, 2015
08:17 EDTRHHBYRoche management to meet with JPMorgan
Meeting to be held in New York on January 29 hosted by JPMorgan.
January 21, 2015
09:02 EDTRHHBYRoche's Ventana seeks FDA premarket approval for ALK IHC lung cancer assay
Roche Group member Ventana Medical Systems announced its FDA submission for premarket approval of the Ventana ALK CDx Assay. The companion diagnostic immunohistochemistry test is designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene. This submission was the fourth and final module and application required by the FDA's PMA process.

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