NEW YORK, NY--(Marketwire -03/29/12)- The FDA is close to approving the first weight loss drug since Roche Holding AG's Xenical in 1999. Obesity treatment manufacturers may need to study the heart risks of their medicines before U.S. regulators weigh approval, Food and Drug Administration staff said in a report. Paragon Report examines the outlook for companies in the Biotechnology Industry and provides equity research on Arena Pharmaceuticals, Inc. (NASDAQ: ARNA - News) and Roche Holding Ltd. (Pinksheets: RHHBY.PK - News).
Vivus Inc., Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc. are in a race to bring the first weight loss pill to the market in 13 years.
An advisory panel will hold a hearing on the drugs in Silver Spring, Maryland, starting March 28. The FDA is not required to follow the panel's recommendations. The potential approvals come 15 years after the fen-phen appetite-suppression drug combination had to be pulled from pharmacies when it was linked to heart valve abnormalities. The advisers will consider whether "obesity drugs without a theoretic risk or signal for" cardiovascular harm "should be required to rule out" some level of cardiovascular risk before approval, the FDA said in the report.
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Arena Pharmaceuticals, Inc. has recently reported that the European Medicines Agency (EMA) has accepted the filing of a Marketing Authorization Application (MAA) for lorcaserin, an investigational drug candidate intended for weight control, including weight loss and maintenance of weight loss, in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition. The acceptance of the MAA filing begins the EMA's review process.
Roche Holding Ltd. announced previously that it has extended its cash tender offer to acquire all outstanding shares of Illumina, Inc., at a price of $44.50 per share, to 6:00 p.m., New York City time, on April 20, 2012. The tender offer was previously scheduled to expire at 6:00 p.m., New York City time, on March 23, 2012.
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- Roche Holding AG