The lead program at Tonix Pharmaceuticals Holding Corp., a medicine aimed at delivering bedtime relief from symptoms of military-related post-traumatic stress disorder (PTSD), failed to adequately separate from placebo in an interim analysis of 12-week phase III data. News of the setback, the second pivotal miss for the drug, sent company shares (NASDAQ:TNXP) down 65.8 percent to $1.35 on Friday, as Tonix pursued hopes that the FDA might judge a future study by a data cut more favorable to the drug. Read More
"Like clockwork, Amgen just finds a way," Piper Jaffray's Christopher Raymond headlined his hot comment on second-quarter earnings from Amgen Inc. Numbers from the Thousand Oaks, Calif-based company were solid, if not spectacular. Quarterly revenues increased 4 percent, to $6.1 billion, over the second quarter of 2017, and global product sales, which included the company's first biosimilar, Kanjinti, grew 2 percent. Read More
Pharmamar SA, of Madrid, said it signed an agreement with Impilo Pharma, a part of Immedica Group, of Stockholm, for the exclusive promotion and distribution of its cancer compound, Yondelis (trabectedin), throughout the Nordic countries and Eastern Europe. Read More
Contrafect Corp., of Yonkers, N.Y., said it priced its underwritten public offering of 5 million shares of its common stock at $2 per share for gross proceeds of $10 million. The company has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock at the public offering price. Read More
The FDA issued a draft of guidelines for providing evidence of effectiveness for replacement or corrective therapies in slowly progressive, low-prevalence rare diseases with substrate deposition that results from single-enzyme defects. Among the topics in the 13-page document is first-in-human dosing. Read More
The gene STK11 encodes the tumor suppressor liver kinase B1 (LKB1), and STK11 mutations promote Peutz–Jeghers syndrome (PJS), a cancer predisposition syndrome. Individuals with PJS are prone to developing gastrointestinal polyps, which can lead to gastrointestinal (GI) tumors. Researchers from the Van Andel Research Institute and the Canadian McGill University have shown that STK11 mutations led to increased inflammation, and that targeting the inflammation could improve outcomes in mouse models of PJS. Read More
It's been more than two decades since Doxil (doxorubicin, Johnson & Johnson), a liposome-based chemotherapy, was approved by the FDA. During that time, the field has evolved from simply protecting other tissue from highly potent drugs until they get to the site of the disease to increasing targeting and bioavailability. Read More
HONG KONG –MSD China Holding Co. Ltd. (known as Merck & Co. Inc. in the U.S. and Canada) received approval for Keytruda (pembrolizumab) in China, making it the second PD-1 inhibitor drug approved in the country after Bristol-Myers Squibb Co.'s Opdivo (nivolumab) and the first one for advanced melanoma. Read More
HONG KONG – Japan's Sanbio Co. Ltd., a maker of regenerative medicines for neurological disorders, is working with Keio University School of Medicine to research its SB-623 drug for the treatment of dementia, including Alzheimer's disease and cerebral vascular dementia. Read More
