One of the very things that could make a biosimilar a more affordable alternative to its reference biologic may be the biggest marketing challenge for the follow-ons in the U.S., at least initially. Read More
Against a backdrop of expanding FDA approvals for opioids, several senators are going over the agency's head to enlist support to fight the accompanying opioid addiction problems. Read More
As widely expected following a positive June advisory vote, the FDA gave its nod to Sprout Pharmaceuticals Inc.'s Addyi (flibanserin) as the first-ever therapeutic approved in the U.S. specifically for hypoactive sexual desire disorder (HSDD) in premenopausal women. Read More
Advocacy groups lobbying for the approval of a therapeutic to treat sexual dysfunction in women celebrated victory late Tuesday with the agency's after-hours nod to Sprout Pharmaceuticals Inc.'s Addyi (flibanserin); however, by Wednesday afternoon, the critics were out in force, accusing the FDA of succumbing to public pressure and approving a drug with a less-than-stellar safety profile. Read More
HONG KONG – China is speeding up approval times and improving the review process for domestic and imported drugs. The ultimate aim of a series of reforms announced this week by the State Council, akin to the cabinet, is to develop a faster and better approvals system that rewards innovation. Read More
A head-to-head study pitting an implantable exenatide-filled osmotic pump developed by Intarcia Therapeutics Inc. against the blockbuster Januvia (sitagliptin, Merck & Co. Inc.) over a year of type 2 diabetes treatment proved the pump superior in reducing HbA1c levels and producing weight loss according to top-line data from the latest of several phase III studies the company has run, positioning Intarcia to file applications seeking approval of the drug-device combination, called ITCA-650, in the first half of 2016. Read More
strong>Medicinova Inc., of La Jolla, Calif., said it priced an underwritten public offering of 5 million shares of its common stock at $3.50 each and the gross proceeds are expected to be $17.5 million. Read More
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the Committee for Medicinal Products for Human Use issued a positive opinion concerning the effort to update the European label of Giotrif (afatinib). Read More
Astex Pharmaceuticals, of Pleasanton, Calif., a unit of Otsuka Pharmaceutical Co. Ltd., of Tokyo, said clinical data for the hypomethylating agent, guadecitabine (SGI-110), were published in The Lancet Oncology. Read More
Inotek Pharmaceuticals Corp., of Lexington, Mass., named Claudine Prowse vice president, strategy and investor relations, and Cadmus Collins Rich vice president, medical affairs and clinical development. Read More
