Article Listing - 1st Cytoprotectant Set For EU Approval
RuiYi and Genor BioPharma collaborate on development in China of RYI-008
17 May 2013
USA and China-based RuiYi says it has entered into an exclusive license and collaborative development agreement with Genor BioPharma for the development of RYI-008 in China. RYI-008 is a novel anti-Interleukin-6 monoclonal antibody with a unique pharmacologic profile that has the potential to define a new paradigm in the treatment of autoimmune diseases and cancer.
Merck KGaA ups commitment to MS Ventures to 100 million euros
16 May 2013
Germany's Merck KGaA says that it will increase its commitment to its strategic corporate venture capital fund MS Ventures to 100 million euros ($130 million). MS Ventures was originally established in March 2009 with a 40 million euros commitment to invest in emerging biotechnology companies.
Vifor gets certain rights to Helsinn's netupitant-palonosetron
16 May 2013
Privately-held Helsinn Healthcare and fellow Switzerland-based Vifor Pharma, part of the Galenica group (SIX: GALN), have entered into an exclusive license and distribution agreement for netupitant-palonosetron fixed dose combination (NEPA), a Helsinn product currently in the development stage for the treatment of chemotherapy-induced nausea and vomiting (CINV).
Improved voluntary harmonization procedure delivers significant benefits for multinational clinical trials in Europe
16 May 2013
The new Voluntary Harmonization Procedure (VHP), a voluntary procedure agreed by the Clinical Trials Facilitation Group (CTFG), a working group of the EU Heads of Medicines Agencies, provides a major breakthrough in getting a harmonized regulatory decision on a clinical trial to be performed in more than one European Union member state.
Australia's revised code to benefit ASX-listed life science companies
16 May 2013
Australia's Minister for Technology, Gordon Rich-Phillips, this week joined forces with the Australian Securities Exchange (ASX) and Australia's biotechnology industry association, AusBiotech, to launch a revised edition of the industry code of best practice that will support capital formation by ASX-listed life science companies.
Merck Serono Ph III trial of L-BLP25 fails endpoint in NSCLC
16 May 2013
Merck Serono, a division of Germany's Merck KGaA (MRK: DE), announced detailed results from the randomized Phase III START trial of its investigational MUC1 antigen-specific cancer immunotherapy L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC), showing the drug failed to meet its primary endpoint.
US FDA approves Janssen's Simponi to treat ulcerative colitis
16 May 2013
The US Food and Drug Administration late yesterday (May 15) approved a new use for Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Ortho Biotech's Simponi (golimumab) injection, to treat adults with moderate to severe ulcerative colitis.
Strong initial data on Genentech's obinutuzumab in most common blood cancer
16 May 2013
Genentech, the biotech subsidiary of Swiss drug major Roche Group (ROG: SIX), has announced positive first results from CLL11, a Phase III study of the investigational drug obinutuzumab (GA101), which is being conducted in collaboration with the German CLL Study Group (GCLLSG).
Europe adopting US strategies to diagnose and treat ADHD
16 May 2013
The impending publication of the fifth edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM-V) later this month may affect diagnosis rates of conditions such as attention-deficit hyperactivity disorder (ADHD), both in the USA and worldwide, says new analysis by GBI Research.
US Senate confirms appointment of Marilyn Tavenner as CMS Administrator
16 May 2013
US Health and Human Services (HHS) Secretary Kathleen Sebelius announced that the US Senate has confirmed Marilyn Tavenner as Administrator of the Centers for Medicare & Medicaid Services (CMS).
- Boehringer Ingelheim gets FDA warning letter on cGMP failures
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- US FDA advisory panel backs approval of Merck & Co's suvorexant, but only at lower doses
- Italy's pharma market slump set to continue, warns GlobalData
- Is failure to adopt business process management putting the pharma industry at risk?
