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Arena and Qnexa Get Good News

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In a continued trend in which the FDA seems to be working toward rapprochement with the previously beleaguered obesity drug industry, this week the agency has in one case asked Qnexa manufacturer Vivus on Monday to remove the contraindication for use of the drug in women of child-bearing potential (although keep in place the contraindication for women actually pregnant), a move that increases the potential obesity drug patient population and the aura of “safety” surrounding Qnexa. 

 

In a continued trend in which the FDA seems to be working toward rapprochement with the previously beleaguered obesity drug industry, this week the agency has in one case asked Qnexa manufacturer Vivus on Monday to remove the contraindication for use of the drug in women of child-bearing potential (although keep in place the contraindication for women actually pregnant), a move that increases the potential obesity drug patient population and the aura of “safety” surrounding Qnexa. 

 

 

In another case, the FDA notified Arena Pharmaceuticals that it has accepted the resubmitted drug application for the company’s obesity drug, Lorcaserin.

 

http://online.wsj.com/article/BT-CO-20120110-706510.html

 

 

Needless to say, both Vivus’ and Arena’s stock price took sharp jumps on the news.
The aggregate worldwide market for obesity drugs could reach $1.8 billion by 2019 if drug approvals happen as forecast for these and other obesity drugs. (See “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019“.

 

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I serve the interests of medical technology company decision-makers, venture-capitalists, and others with interests in medtech producing worldwide analyses of medical technology markets for my audience of mostly medical technology companies (but also rapidly growing audience of biotech, VC, and other healthcare decision-makers). I have a small staff and go to my industry insiders (or find new ones as needed) to produce detailed, reality-grounded analyses of current and potential markets and opportunities. I am principally interested in those core clinical applications served by medical devices, which are expanding to include biomaterials, drug-device hybrids and other non-device technologies either competing head-on with devices or being integrated with devices in product development. The effort and pain of making every analysis global in scope is rewarded by my audience's loyalty, since in the vast majority of cases they too have global scope in their businesses. Specialties: Business analysis through syndicated reports, and select custom engagements, on medical technology applications and markets in general/abdominal/thoracic surgery, interventional cardiology, cardiothoracic surgery, patient monitoring/management, wound management, cell therapy, tissue engineering, gene therapy, nanotechnology, and others.
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