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News Breaks
June 4, 2014
10:14 EDTAZN, RHHBYRoche, AstraZeneca units collaborate on PD-L1 assay for immunotherapy trials
Ventana Medical Systems, a member of the Roche Group (RHHBY), and MedImmune, the biologics research and development arm of AstraZeneca (AZN), announced they are jointly developing a PD-L1 immunohistochemistry assay to enroll patients in clinical trials for MedImmune's MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. This includes the recently commenced MEDI4736 ATLANTIC trial that will enroll only patients who express PD-L1 as determined by the VENTANA assay.
News For RHHBY;AZN From The Last 14 Days
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December 19, 2014
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.
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 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
07:33 EDTAZNAdvaxis announces FDA acceptance of INDA to commence clinical trials of ADXS-HPV
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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 11, 2014
16:03 EDTAZNAmgen, AstraZeneca to present results from Phase 3 plaque psoriasis study
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07:28 EDTAZNCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
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.
09:10 EDTAZNARIAD takeover rumors rekindled, Independent says
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08:02 EDTAZNMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTRHHBY, AZNAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.
December 5, 2014
11:33 EDTRHHBYGenentech to present clinical data at ASH
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09:49 EDTAZNUBS European pharmaceuticals analysts holds analyst/industry conference call
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