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Policy & Regulation - Pharmacovigilance
EVENTS
22 March 2010
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12 April 2010
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13 April 2010
London, UK
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Health Canada finalises guidance on biosimilars
Today
Health Canada has issued its much-awaited final guidance on the authorisation of subsequent entry biologics (SEBs), also referred to as biosimilars or follow-on biologics in some jurisdictions. The final document builds on two draft versions of the ...
MannKind's inhaled insulin Afrezza hit with US FDA complete response letter
Today
Shares in the US company MannKind dropped by 25% earlier this week as investors reacted to a US FDA complete response letter for its inhaled rapid-acting insulin product Afrezza (formerly Afresa). The product is awaiting a decision for the ...
Novartis drops post-MI development of Tekturna on Phase II failure
Today
Novartis 's first-in-class direct renin inhibitor antihypertensive Tekturna (aliskiren) failed to reduce heart remodelling when used as a post-myocardial infarction (MI) treatment, show Phase II results presented at the American College of ...
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. ...
 
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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