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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.
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December 19, 2014
11:32 EDTRHHBYRoche acquires privately held Bina Technologies
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09:48 EDTRHHBYBiogen should be bought on weakness after Roche drug halted, says Evercore ISI
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09:28 EDTRHHBYOn The Fly: Pre-market Movers
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08:53 EDTRHHBYBiogen drug, trial differs from Roche Alzheimer's drug, says RBC Capital
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08:51 EDTRHHBYBiogen drops 2% after Roche discontinues Alzheimer drug trial
Shares of Biogen (BIIB) are moving lower after Roche (RHHBY) announced the discontinuation of its Alzheimer's drug gantenerumab, which was in Phase III testing. Analysts at Wells Fargo said Roche's trial failure adds risk to Biogen's potential treatment of Alzheimer's. Shares of Biogen are down $8.20 to $345.50 in pre-market trading.
08:34 EDTHALOHalozyme receives EU Orphan Drug designation for PEGPH20
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06:12 EDTRHHBYRoche says breast cancer study did not meet PFS superiority endpoint
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06:10 EDTRHHBYRoche to discontinue Phase III study of Alzheimer's disease drug
Roche announced the decision to discontinue SCarlet RoAD, a phase III study of investigational anti-amyloid medicine gantenerumab in prodromal Alzheimer’s disease, based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee. No new safety signals for gantenerumab were observed in this analysis and the overall safety profile was similar to that seen in the phase I trial, Roche said. Data from the SCarlet RoAD study will be shared with the medical community after full review and analysis, it added. "We are disappointed with these study results because people with early stage Alzheimer's need new medicines that delay disease progression,” said Sandra Horning, M.D., Chief Medical Officer at Roche. "This is the first Phase III trial to evaluate a potential disease-modifying medicine in this early prodromal stage of Alzheimer’s disease. We remain committed to investigating new medicines for this devastating illness."
05:36 EDTRHHBYImmunoGen reports Phase III MARIANNE study met non-inferiority endpoint
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05:33 EDTRHHBYGenentech provides update on Phase III MARIANNE
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December 18, 2014
12:46 EDTRHHBYRoche acquires privately held Dutalys for $133.75M up front
Roche announced that it has agreed to acquire Dutalys GmbH, a privately held biotechnology company based in Vienna, Austria. Dutalys specializes in the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMab technology, Roche said. Under the terms of the agreement, Roche will make an upfront cash payment of $133.75M to shareholders and make additional contingent payments of up to $355M based on the achievement of certain predetermined milestones.
December 17, 2014
09:13 EDTHALOHalozyme up nearly 5% after announcing collaboration pact with Janssen
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09:04 EDTHALOHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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09:02 EDTHALOHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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December 16, 2014
08:47 EDTRHHBYHemispherx Ampligen provides anti-tumor activity
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05:46 EDTRHHBYRoche launches PCR molecular diagnostic system for point of care environment
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December 15, 2014
05:24 EDTRHHBYExelixis announces Genentech files NDA for cobimetinib, vemurafenib combination
Exelixis (EXEL) announced its collaborator Genentech, a member of the Roche Group (RHHBY), has completed the filing of its New Drug Application, or NDA, with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
December 12, 2014
05:52 EDTRHHBYRoche announces retirement of Genentech research head
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December 9, 2014
12:22 EDTRHHBYPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
07:44 EDTRHHBYAmerican Association for Cancer Research to hold a symposium
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