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News Breaks
January 21, 2014
06:04 EDTRHHBYRoche says two phase III schizophrenia studies missed primary endpoints
Roche announced that two phase III studies of its investigational medicine bitopertin in adults with persistent, predominant negative symptoms of schizophrenia failed to meet their primary endpoints, based on the negative symptoms factor score of the positive and negative symptom scale. Negative symptoms include social withdrawal and lack of motivation. A third phase III study evaluating bitopertin for persistent, predominant negative symptoms of schizophrenia is ongoing. In addition, three phase III studies investigating bitopertin for sub-optimally controlled symptoms of schizophrenia are in progress. "These results are disappointing for people with negative symptoms because more effective treatments are needed for these debilitating effects of schizophrenia, said Sandra Horning, M.D., Chief Medical Officer at Roche. "We will await data from the remaining bitopertin studies in schizophrenia before deciding on next steps."
News For RHHBY From The Last 14 Days
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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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December 5, 2014
11:33 EDTRHHBYGenentech to present clinical data at ASH
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