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Research & Development - Product Safety
EVENTS
01 January 1970
London, UK
01 January 1970
San Diego, US
01 January 1970
Providence, Rhode Island, and San Francisco, California
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The US agency that runs Medicare – the Centers for Medicare and Medicaid Services (CMS) - has scheduled a 17 November advisory panel meeting to consider on-label and off-label use of Dendreon's prostate cancer treatment Provenge (sipuleucel-T). ...
The US FDA has issued a warning letter to a wholly owned US unit of India's Sun Pharmaceutical Industries in Cranbury, New Jersey, over good manufacturing practice (GMP) deviations at the plant. FDA inspectors made a number of observations, which ...
GlaxoSmithKline and Valeant Pharmaceuticals have hit a three-month delay in achieving US approval for their novel antiepileptic Potiga (ezogabine). The US FDA has pushed back the PDUFA goal date for the NDA until 30 November while it reviews a risk ...
After months of speculation Sanofi-Aventis, the French pharma major, at the weekend unveiled an all-cash $69.00 a share bid for Genzyme, which values the US biotech at about $18.5 billion. Not surprisingly, the Genzyme board unanimously rejected the ...
Widening losses at Oxford BioMedica in the first half of 2010 were tempered by positive news on a number of the company's product development programmes. These included possibilities for accelerating clinical trials with ProSavin, the gene-based ...
 
Continued problems with anti-obesity drugs, more measures designed to improve R&D efficiency, and the approval of first-in-class therapeutics such as Amgen's Prolia and Dendreon's Provenge: the first ...
New drugs to treat viral hepatitis infection, coupled with renewed interest from companies in developing therapies to treat liver cancer following Nexavar's approval, have improved prospects for both ...
Ian Schofield picks some of the most significant developments in the health policy and regulation circles in the first half of 2010 and explains their likely impacts on pharma. Barack Obama signed ...
 
GW Pharma has enjoyed recent success with its cannabinoid extract product Sativex (nabiximols), which is now approved in the UK and Spain as an add-on therapy for spasticity in multiple sclerosis, ...
Actelion this week acquired the option to buy private company Trophos, with the final decision dependent on the success of the French firm's lead product olesoxime, which is in Phase III development ...
Croatia's HZZO main responsibilities include setting drug prices, selecting reimbursable products and reimbursement. The institute uses France, Italy and Slovenia as reference countries for setting ...
 
While the UK's NHS and pharma sector ponder who may end up negotiating drug prices in light of a new white paper, health economists Stuart Carroll, Neil Hawkins and David A Scott contemplate four ...
After enjoying almost five years of exclusivity, Lilly/Amylin's first-in-class antidiabetic GLP-1 receptor analogue Byetta (exenatide) has started to feel competition nipping at its heels. Asher ...
On 1 July 2010 the EU General Court handed down its judgement in the long-running saga of AstraZeneca's proton pump inhibitor anti-ulcer product Losec (omeprazole). Although dealing with events that ...
 
Crohn's disease and ulcerative colitis represent the most common forms of inflammatory bowel disease (IBD), clinical conditions affecting the small and/or large bowel. It is well known that IBD is an ...
Sir James Black, the 1988 recipient of the Nobel Prize for the invention of propranolol and cimetidine, opened the 2007 Safety Pharmacology (SP) Society annual meeting with a lecture on his ...
The primary goal of this meeting was to propose strategies for expediting the Phase 0 drug research process for valuable drug candidate identification by taking full advantage of innovative ...
 
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