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Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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European Commission approves Genzyme’s multiple sclerosis treatment Lemtrada™ (alemtuzumab)
17 September 2013 | By Genzyme
Follows recent European Commission approval of multiple sclerosis treatment Aubagio® (teriflunomide)...
FDA approves Teva’s TREANDA® (bendamustine HCI) injection, a new liquid formulation
17 September 2013 | By Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) approved TREANDA (bendamustine HCI) Injection, a new formulation of the currently approved TREANDA (bendamustine HCI) for Injection.
Volasertib receives FDA Breakthrough Therapy designation for treatment of patients with acute myeloid leukaemia
17 September 2013 | By Boehringer Ingelheim
Administration (FDA) to potentially provide a new treatment option to improve survival related outcomes for patients with acute myeloid leukaemia (AML)...
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.
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...
