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Research & Development - Product Safety
EVENTS
22 March 2010
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13 April 2010
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DIRECTORY Scrip Directory 2009
Roche files Actemra for prevention of joint damage in US
17 March 2010
Genentech ( Roche ) has submitted a supplemental BLA to the US FDA for its first-in-class interleukin-6 inhibitor Actemra (tocilizumab) for an indication of prevention of structural joint damage and improvement of physical function in adults with ...
Key MEP says EU patient information proposal "must go through"
17 March 2010
The MEP responsible for guiding the controversial patient information proposal through the European Parliament says he is not prepared to see it derailed by opposition from member state ministers and certain political groupings in parliament. ...
Merck/Portola's betrixaban shows bleeding benefit in Phase IIb
16 March 2010
Merck / Portola Pharmaceuticals ' investigational Factor Xa inhibiting anticoagulant betrixaban was associated with significantly less clinically relevant bleeding than warfarin when given at 40mg/day to patients with atrial fibrillation, show new ...
Genzyme plays down latest Cerezyme impurity
16 March 2010
Genzyme has just revealed that it found an impurity in a single vial of its Gaucher's disease drug Cerezyme (imiglucerase) from its fill-finish facility in Waterford, Ireland last December. However, it downplayed the problem, noting that the ...
ACCORD LIPID: Fenofibrates fail to improve cardiovascular outcomes type 2 diabetics
15 March 2010
Hypolipaemic fenofibrates such as Abbott s' TriCor, its next-generation Trilipix and generics, do not improve cardiovascular outcomes in patients with type 2 diabetes when used in combination with simvastatin (Merck & Co's lipid-lowering Zocor). The ...
 
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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