Development Suspended On Obesity Drug Tied To Two Deaths
The drugmaker, Boston-based Zafgen, also announces that it will lay off a third of its employees. In other pharmaceutical news, biotech company Synthorx says it will enter the biologic drug market with two new synthetic nucleotides to add to DNA library. And two Valeant drugs get FDA scrutiny.
Stat:
Once-Promising Obesity Drug Is Scrapped After Patient Deaths
A once-promising treatment for obesity is now all but abandoned, as the biotech company that developed the drug scrapped efforts to bring it to market after it was tied to two patient deaths. Zafgen announced Tuesday it will lay off a third of its workforce, about 16 people, as it pivots to focus on a different experimental drug in an earlier stage of development. Management hopes the new product can spur weight loss without the same safety issues. (Garde, 7/19)
Boston Globe:
Boston’s Zafgen Cuts Jobs, Shifts Focus On Obesity Drugs After Deaths In Clinical Trials
Zafgen Inc. suspended development of an obesity drug whose testing was put on hold last year after two patients died during a clinical trial. The Boston company said Tuesday in a statement that it would focus its resources on a separate obesity drug that will soon enter clinical studies. As part of the shift, the company will reduce its workforce by 34 percent, from 47 to 31 employees, chief executive Thomas Hughes told analysts on a conference call. (Weisman, 7/19)
Stat:
A Biotech Startup Is Expanding The DNA Alphabet In Hopes Of Making Novel Drugs
San Diego synthetic biology company Synthorx is entering the drug discovery game with a couple extra base pairs up its sleeve: It’s developing new biologic drugs with an expanded DNA alphabet, adding synthetic nucleotides X and Y to the standard lineup of A, C, G, and T. The company just raised $10 million, on top of $6 million in investment it collected back in 2014. CEO Court Turner spoke with STAT about the company’s technology — and its plans for developing drugs for diabetes and other conditions with that loaded-up DNA. (Keshavan, 7/20)
Bloomberg:
Valeant Drug Should Be Approved With Risk Plan, FDA Advisers Say
Valeant Pharmaceuticals International Inc. won the backing of a panel of U.S. regulatory advisers who supported approval of its experimental psoriasis treatment, on the condition that the company takes extra steps to help mitigate possible suicide risk associated with the drug. Food and Drug Administration advisers voted Tuesday to recommend that the agency clear the drug, brodalumab, for sale with the risk-management plan and a label that warns it may be linked to a higher risk of suicide. (Edney, 7/19)
The Wall Street Journal:
Valeant Gets FDA OK For Anticonstipation Tablets Developed By Progenics
Valeant Pharmaceuticals International Inc. has received U.S. Food and Drug Administration approval for Relistor tablets to treat opioid-induced constipation for patients with noncancer pain. (Beckerman, 7/19)
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