Christoph Franz nominated to become new Roche Chairman
16 September 2013 | By Roche
At the forthcoming Annual Shareholders Meeting on 4 March 2014, the Roche Board of Directors will propose Christoph Franz to be elected as Chairman of the Board.
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GSK receives Priority Review from FDA for dabrafenib / trametinib combination in metastatic melanoma
16 September 2013 | By GSK
GlaxoSmithKline has announced that the FDA has granted Priority Review designation to its supplemental New Drug Applications (sNDAs) for combined use of Tafinlar® (dabrafenib) and Mekinist® (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.
Cancer Research and Teva form alliance for R&D DNA damage response drugs
16 September 2013 | By Cancer Research Technology Ltd.
Cancer Research Technology and Teva Pharmaceutical have signed a multi-project alliance agreement to research and develop first-in-class cancer drugs that modulate DNA damage and repair response (DDR) processes in cancer cells...
Sanofi provides update on lixisenatide New Drug Application in U.S.
12 September 2013 | By Sanofi
Sanofi announced its decision to withdraw the lixisenatide New Drug Application (NDA) in the U.S...
Bristol-Myers Squibb Reports Results for Phase 3 Trial of Yervoy® (Ipilimumab) in Previously-Treated Castration-Resistant Prostate Cancer
12 September 2013 | By Bristol-Myers Squibb Company
Results from the Phase 3 randomized, double-blind clinical trial (Study 043)...
Winning comes naturally to GXPi
11 September 2013 | By Three Thinking Co.
Regulatory compliance specialist GXPi has announced the appointment of Richard Winning...
AstraZeneca and Merck enter licence agreement for investigational oral WEE1 kinase inhibitor therapy for cancer
11 September 2013 | By AstraZeneca
AstraZeneca and Merck & Co Inc, announced a worldwide licensing agreement for Merck’s oral small molecule inhibitor of WEE1 kinase (MK-1775)...
Gilead submits New Drug Application to U.S. FDA for Idelalisib for the treatment of indolent non-Hodgkin’s lymphoma
11 September 2013 | By Gilead Sciences
Gilead Sciences, Inc. has submitted a NDA to the U.S. FDA for approval of idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of iNHL...
Analysis published in New England Journal of Medicine highlights discovery of new predictive biomarkers for Vectibix® (panitumumab)
11 September 2013 | By Amgen
Study links RAS mutations to Vectibix clinical response in patients with metastatic colorectal cancer...
Boehringer Ingelheim broadens efforts for interferon-free hepatitis C treatments through clinical collaboration with Presidio Pharmaceuticals
10 September 2013 | By Boehringer Ingelheim
Boehringer Ingelheim announced the completion of patient enrolment for a Phase IIa clinical trial...
FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD
10 September 2013 | By GlaxoSmithKline
GSK and Theravance, Inc. announced that the PADAC to the US FDA voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol...
Catalent appoints first President of Asia Pacific
9 September 2013 | By Catalent Pharma Solutions
Catalent Pharma Solutions has named David Heyens in the new role of President of Catalent Asia Pacific...
Merck announces FDA acceptance of New Drug Application for investigational fertility treatment
9 September 2013 | By Merck
Merck announced that the NDA for its investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the U.S. FDA...
Biogen Idec and Isis Pharmaceuticals announce strategic collaboration to advance treatment of neurological disorders
9 September 2013 | By Biogen Idec
Biogen Idec and Isis Pharmaceuticals, Inc. announced that the companies have entered into a broad, multi-year collaboration...
Phase III results: Once daily olodaterol* Respimat® provides effective and sustained improvements in lung function in patients with COPD1-3
9 September 2013 | By Boehringer Ingelheim
Data from two 48 week Phase III studies involving more than 3,000 patients...
