Cellectar Biosciences Inc., of Madison, Wis., said the FDA accepted its investigational new drug application to begin clinical trials of I-131-CLR1404, a highly selective, cancer-targeting radiopharmaceutical, in patients with relapsed or refractory multiple myeloma. Read More
Theratechnologies Inc., of Montreal, said the first shipment of Egrifta (tesamorelin) was sent to its U.S.-based wholesale distributor to replenish the supply chain and will be available once again to patients by mid-September. Read More
Foamix Pharmaceuticals Ltd., of Rehovot, Israel, said it set terms for its initial public offering, planning to raise $65 million from the sale of 6 million shares at a price range of $10 to $12 to help fund phase III studies of its lead product candidates, FMX101 for moderate to severe acne and FMX102 for common skin infection impetigo. Read More
HONG KONG – As researchers around the world speed up their efforts to develop and register new and more effective treatments for Ebola, China announced the approval of its first drug against the fatal virus for emergency use. Read More
Rumors of an early approval for Merck & Co. Inc.'s high-profile PD-1 inhibitor Keytruda (pembrolizumab) turned out to be no exaggeration, as the FDA gave its nod to the drug Thursday for use in patients with advanced or unresectable melanoma who are no longer responding to other drugs. Read More
Shares of Flexion Therapeutics Inc. got a boost Thursday morning after the company disclosed plans to launch a pivotal phase III trial of lead candidate FX006 by year-end and to complete the study by the end of 2015 – a year earlier than initially planned. Read More
The oft-cited "favorable trends" in otherwise failed phase II/III data with Kamada Ltd.'s inhaled alpha-1 antitrypsin therapy (AAT) may just be adequate to win European Union (EU) marketing approval, and the company is forging ahead. Read More
Eli Lilly and Co., of Indianapolis, said basal insulin peglispro (BIL) demonstrated a statistically significant lower hemoglobin A1c (HbA1c) compared with Lantus (insulin glargine, Sanofi SA) at 26 weeks and 52 weeks, respectively, in the IMAGINE-1 and IMAGINE-3 phase III trials in patients with type 1 diabetes. Read More
