Article Listing - Ipsen, Inamed start Ph II botulinum toxin study
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).
Fast FDA approval for Bayer's new drug for advanced prostate cancer, Xofigo
16 May 2013
The US Food and Drug Administration yesterday (May 15) approved Xofigo (radium Ra 223 dichloride, initially called Alpharadin), from German drug major Bayer (BAYN: DE), to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer.
Merck Serono and Quintiles enter novel clinical development partnership
16 May 2013
Merck Serono, the biotech division of Germany's Merck KGaA (MRK: DE) and Quintiles (NYSE: Q) have announced a new, five-year clinical development agreement. This strategic collaboration is the first-of-its-kind between a biopharmaceutical company and a biopharmaceutical services provider, creating a comprehensive process that integrates the expertise and experience from both organizations into a single, well-aligned clinical development engine, the German firm says. Financial terms of the accord were not revealed.
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