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Research & Development - Product Approvals
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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 ...
By a decisive 9-3 vote, the US FDA 's advisory committee on pulmonary drugs on March 9th recommended that the agency approve the new drug application (NDA) from InterMune to market as a treatment its drug Esbriet (pirfenidone) to reduce the decline ...
An advisory committee to Japan's ministry of health, labour and welfare has recommended for approval Takeda 's oral antidiabetic, alogliptin. The positive opinion moves the DPP-4 inhibitor closer to what is likely to be its first market, following ...
By a 13-to-5 vote, the US FDA 's advisory committee on cardiovascular and renal drugs on March 1st recommended that the agency grant Bristol-Myers Squibb 's biologics licence application for belatacept, to be used to prevent rejection of ...
Takeda has received an approval recommendation in Japan for its EGFR-targeted human monoclonal antibody, Vectibix (panitumumab), for the treatment of colorectal cancer. The product, submitted in June 2008, was the subject of a positive opinion from ...
 
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. ...
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 ...
The global economic crisis has had a significant negative impact on all areas of life, including labour and property markets, national banking systems and the prices of consumer goods. With so many ...
 
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 ...
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 ...
Six out of the top 10 emerging markets in the world to conduct clinical trials are now in the Asia-Pacific region, Albert Liou, general manager of this region for biopharmaceutical services firm ...
 
Logos are said to be an important part of an organisation's branding. Really good logos contribute to an organisation's visibility, credibility and memorability, so say branding experts. The logo of ...
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 ...
On July 8th, 2009, the European Commission reported on its 18-month inquiry into competition in the pharmaceuticals sector. Bill Batchelor of Baker & McKenzie 's Brussels antitrust practice ...
 
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