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Research & Development - Product Safety
EVENTS
17 March 2010
Berlin, Germany
17 March 2010
Berlin, Germany
22 March 2010
London, UK
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DIRECTORY Scrip Directory 2009
US FDA advisory committees back randomised trials for LABA safety
12 March 2010
The US FDA was established in 1931, but only three years ago did it get the power to order drug makers to conduct safety studies of products that have already been approved and put into general use. Just how difficult it is going to be to use that ...
Avastin fails only Phase III trial in advanced prostate cancer
12 March 2010
Roche 's Avastin (bevacizumab), the world's best-selling cancer drug, has failed to prolong overall survival in its only Phase III trial in advanced prostate cancer, CALGB 90401, which was sponsored by the US National Cancer Institute (NCI). Roche ...
Europe to give €12 million for influenza antiviral projects
12 March 2010
The European Commission will provide €12 million in funding for two new research projects which will develop novel influenza treatments, including against both (A) H1N1 pandemic influenza and (A) H5N1 avian flu. Speaking at an EU influenza meeting ...
Actelion needs to provide more info to FDA for Zavesca in Niemann-Pick disease
12 March 2010
The US FDA has issued Actelion with a complete response letter for its drug Zavesca (miglustat), for the treatment of progressive neurological manifestations in adults and children with Niemann-Pick type C (NP-C) disease – a rare, fatal ...
FDA continues "safety review" of potential link between bisphosphonates and fractures
11 March 2010
The US FDA has announced an "ongoing safety review" of oral bisphosphosphonates to see if they are potentially linked to atypical subtrochanteric femur fractures, or fractures in the bone just below the hip joint. For the data reviewed to date, ...
 
Market Insight: Big pharma hit by Greece's fiscal crisis
09 March 2010
Hospitals' failure to pay pharmaceutical companies and newly announced price cuts are just some of the challenges facing the sector in Greece, Elizabeth Sukkar, Scrip's world editor, discovers. ...
Market Insight - Pharma sector in Turkey to shrink 25% under tough conditions
02 March 2010
The pharmaceutical industry has long eyed Turkey as one of its key emerging markets, but recent government action, which could see medicine access delayed by years, is giving it a wake-up call, ...
Market Insight - Power of observation propels comparative effectiveness research into the mainstream
02 March 2010
US agencies are making inroads in the use of comparative effectiveness research to support more robust decision-making. Observational studies are an emerging force in this area and promise to ...
 
Interview: European Medicines Agency gets serious about its global strategy
29 January 2010
Developing relationships with medicine regulators in China and India is just one of the challenges facing Emer Cooke, the international face of the European Medicines Agency (EMA), Scrip's Elizabeth ...
Face to face: Ex-Novartis manager takes two-step approach to women's health at Lumavita
12 January 2010
Many pharmaceutical and biotech companies devote themselves to the discovery and development of novel drugs for unmet medical needs. However, with R&D costs and regulatory hurdles multiplying, and ...
Anti-obesity drugs: an inventor's perspective
20 November 2009
After years of anti-obesity disappointments, Orexigen's Contrave, Vivus's Qnexa and Arena's lorcaserin stand on the verge of being filed with the US FDA. Professor Michael Cowley, inventor of ...
 
Pfizer's fine: a revisit of self-regulation
10 September 2009
The US is a great place to do business. Being an almost free market, the profits are good, but so also are the temptations. So if you can't be bothered to put the money into a clinical trial to find ...
Commentary: 10 pro-innovation biopartnering trends
01 September 2009
1. risk aversion converges with focus on quality The rise and rise of the biotech sector and big pharma's increasing reliance on biological products as sources of future innovation are well ...
How to mobilise the vaccine industry in a crisis
07 September 2009
Has the swine flu outbreak exposed a failure in US public health planning? Robert Hutchens, a partner at the consulting firm Booz & Co, describes the problems associated with developing and marketing ...
 
Long-term treatment with infliximab in inflammatory bowel disease: safety and tolerability issues
01 September 2008
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 ...
Safety Pharmacology Society: 7th Annual Meeting
01 January 2008
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 ...
Optimizing the preclinical/clinical interface: an Informa Life Sciences conference
01 March 2007
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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