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EVENTS
Today
Berlin, Germany
Today
Berlin, Germany
22 March 2010
London, UK
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DIRECTORY Scrip Directory 2009
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 ...
No new trials needed in US FDA complete response letter for once-weekly exenatide
15 March 2010
Amylin Pharmaceuticals , Lilly and Alkermes ' type 2 diabetes candidate Bydureon (exenatide for extended-release injectable suspension) – a once-weekly formulation of the twice-daily dosed Byetta – has received a complete response letter from the US ...
Counterfeiters beware: WHO shows poor countries how to procure antimalarials
10 March 2010
Establishments that produce substandard or counterfeit antimalarials will find it harder to sell their products to developing countries after the World Health Organization published new guidelines this week spelling out how to buy quality-made ...
US FDA approves CombinatoRx/Covidien's extended-release Exalgo for pain
03 March 2010
The US FDA has approved CombinatoRx / Covidien 's Exalgo (extended-release hydromorphone) for the management of moderate to severe pain in opioid-tolerant patients who need around-the-clock analgesia. "Investor expectations were low given two ...
Snow delays Amylin/Lilly's once-weekly Byetta
26 February 2010
Extreme weather has forced the US FDA to push back by one week the PDUFA date for Amylin / Lilly 's once-weekly formulation of Byetta (exenatide), an injectable GLP-1 analogue for the treatment of type 2 diabetes. The drug's new PDUFA is March 12th. ...
 
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 - 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 ...
Market Insight - Differentiation guiding firms through maze of hepatitis C drug development
22 January 2010
The therapeutic landscape in HCV treatment is at an inflection point – recent data from the first generation of protease inhibitors promise the dawn of a new standard of care. But do not expect to ...
 
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 ...
e-Therapeutics: leveraging unique drug discovery to secure partners
07 September 2009
As big pharma braces itself for the 2012 "winter of discontent", when several key drugs lose patent protection, these patent expiries also represent an opportunity for other firms. e-Therapeutics is ...
 
Commentary: Experts alert to dangers of panic over flu pandemic
14 August 2009
Last month's launch of the National Pandemic Flu Service in the UK was hailed by some as an innovative way of easing the burden of the imminent pandemic on the country's already over-worked National ...
Patent attack - The interim findings of the European Commission's pharmaceutical sector inquiry
15 December 2008
Some 10 months and 6,000 submissions later, the interim findings on competition in the EU pharmaceutical sector were unveiled at a conference in Brussels on November 28th. Initially billed by ...
Life under FDAAA: Four months of post-approval studies and REMS
01 August 2008
The FDA has not hesitated to use its new safety powers since they took effect on March 25th. A review of original and supplemental NDA and BLA approval letters on the FDA's website indicates that, ...
 
Protective efficacy of different strategies employing Mycobacterium leprae heat-shock protein 65 against tuberculosis
01 September 2008
Background: Tuberculosis is a major threat to human health. The high disease burden remains unaffected and the appearance of extremely drug-resistant strains in different parts of the world argues in ...
Morphine sulfate extended-release capsules for the treatment of chronic, moderate-to-severe pain
01 June 2008
Background: Morphine sulfate extended-release capsules (KADIAN ® ) contain polymer-coated morphine sulfate pellets that are formulated to deliver sustained plasma morphine levels with minimal ...
Lisdexamfetamine dimesylate: the first long-acting prodrug stimulant treatment for attention deficit/hyperactivity disorder
01 June 2008
Background: Lisdexamfetamine dimesylate is the first long-acting prodrug stimulant and is indicated for the treatment of attention deficit/hyperactivity disorder. Lisdexamfetamine dimesylate is a ...
 
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