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Policy & Regulation - Pharmacovigilance
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 ...
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, ...
Swifter market access for drugs will require a revolution
11 March 2010
The plenary session at the Drug Information Association’s Euromeeting in Monaco this week took the curious form of an enforced debate on pharmaceutical R&D productivity between representatives from the industry and regulatory authorities. The motion ...
 
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 ...
Market Insight - Fear gives way to prudence as VCs eye return of bull biotech market
19 February 2010
2009 was a bad year for investment in the biotech sector, with venture capital funds fleeing to safer havens and many small firms struggling to get enough financing to keep their R&D projects afloat. ...
Market Insight - Microdosing reaching a tipping point?
05 February 2010
Advocates of microdosing, a technique that involves testing very small doses of products in humans, think it will improve the efficiency of drug development by flagging at an early stage those ...
 
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 ...
 
GSK's malaria vaccine sails towards uncharted territory
05 November 2009
GlaxoSmithKline will enter unknown regulatory waters when it eventually comes to seek approval of its paediatric malaria vaccine, RTS,S, the most advanced in development for this disease. The parasite kills more than 800,000 people every year, the ...
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 a new indication for your product, you could ...
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 established industry trends. Interesting, therefore, to ...
 
Clinical immunotoxicity of therapeutic proteins
11 May 2009
Therapeutic proteins are proteins engineered in the laboratory for pharmaceutical use. Although they tend to offer a better safety margin than most synthetic small molecules because they are processed by the same pathways as natural proteins in the ...
Etravirine: the renaissance of non-nucleoside reverse transcriptase inhibitors
01 December 2008
Background: Etravirine is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to be active against human immunodeficiency virus with NNRTI mutations. Objective: To understand the unique features of etravirine and to evaluate its safety, ...
Polycystic ovary syndrome: treatment strategies and management
01 December 2008
Background: The polycystic ovary syndrome (PCOS) is possibly the most common endocrine disorder in premenopausal women, with prevalences in the 6 – 7% range reported worldwide. Although PCOS is primarily a disorder of androgen excess, affected women ...
 
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