A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.
Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
Kintai Therapeutics Inc. CEO, president and board member Paul-Peter Tak told BioWorld that the company aims to reach the clinic in the first quarter of next year with obesity agent KTX-0200, which has begun IND-enabling studies after showing sustained weight loss and improved markers of health in preclinical experiments.
Anorexia nervosa, Cynthia Bulik told BioWorld, has a long-term recovery rate of 25% and “the highest fatality rate of any psychiatric illness.” Those dismal statistics hint at the challenging nature of anorexia nervosa, but also at the shortcomings of current treatment options.
HONG KONG – Belgian drugmaker Janssen Pharmaceutical NV, a subsidiary of Johnson & Johnson, has decided to return the rights of diabetic obesity treatment HM-12525A to Hanmi Pharmaceuticals Co. Ltd. The South Korean company said the decision followed phase II testing by Janssen, which showed the drug achieved the weight loss endpoint but didn't reach Janssen's internal criteria for blood glucose control in obese patients with diabetes.
At a family wedding earlier this month, an uncle was salivating over the prospect that the Vivus Inc. drug Qnexa could soon become the first in a new generation of obesity drugs to gain FDA approval. He needed to lose 50 pounds, he confided, and the drug seemed the answer to his prayers. Since we’ve written extensively about obesity and these drugs in BioWorld Today, he wanted my opinion. I politely inquired whether he had considered dieting and exercise, which could produce similar results without the potential side effects of a prescribed drug – especially one in a category that’s...