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News Breaks
August 14, 2014
16:02 EDTRHHBYFDA approves Genentech’s Avastin plus chemotherapy for cervical cancer treatment
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration approved Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix. “With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread.” With this approval in advanced cervical cancer, Avastin is approved in the United States to treat five distinct tumor types. The approval in advanced cervical cancer was based on the GOG-0240 study.
News For RHHBY From The Last 14 Days
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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 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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