Gtx Inc.'s blowup in two Phase III trials with enobosarm for muscle wasting in non-small-cell lung cancer patients (NSCLC) left the company with apparently dicey odds for approval in the U.S., where the FDA has granted the selective androgen receptor modulator fast-track status, but CEO Mitchell Steiner told investors that the "compelling" results provide cause for hope that marketing clearance might be gained in Europe. Read More
SHANGHAI – Highlighting increasing public concern over drug, device and food safety in China, a crackdown on illegal pharmaceutical advertising has led to a dramatic increase in the number of reported cases. Read More
Shares in Immunicum AB surged more than 40 percent Monday on promising signals from a Phase I/II trial of its kidney cancer vaccine, Intuvax. The optimism is based on preliminary data from a very small-scale study. Read More
The FDA is getting ready to take its Secure Supply Chain Pilot Program (SSCPP) out for a two-year test flight, and it's looking for up to 100 drugmakers to sign on for the ride. Read More
Pain Therapeutics Inc. and Durect Corp. each enjoyed a stock surge when news got out that Pfizer Inc. began a new clinical trial of Remoxy (oxycodone) three months after the pharma had signaled that it was considering discontinuation of the product. Read More
• Genspera Inc., of San Antonio, said it entered subscription agreements with accredited investors and qualified institutional buyers totaling approximately $5 million. Read More
• Fibrocell Science Inc., of Exton, Pa., disclosed positive results from a study demonstrating a potential mechanism for converting research-grade adult skin cells into clinical grade induced pluripotent stem (iPS) cells. Read More
• Bind Therapeutics Inc., of Cambridge, Mass., dosed its first patient in a Phase II trial of BIND-014, for metastatic castrate-resistant prostate cancer. Read More
• Novo Nordisk A/S, of Bagsvaerd, Denmark, announced a program to repurchase B shares for up to DKK2.5 billion (US$447.1 million) between Aug. 8, 2013, and Oct. 29, 2013. Read More
