Alkermes plc’s just-won fast-track status for its depression drug, Alks 5461 – along with the willingness of the FDA to let the company skip the end-of-Phase II meeting and move directly into Phase III, as outlined in the firm’s briefing documents – have brought the pivotal trial’s design into the spotlight. Read More
In another piece of good news for the biotech initial public offering (IPO) market, Macrogenics Inc. priced its IPO as expected Thursday, selling 5 million shares at $16 apiece, and then watched as shares (NASDAQ:MGNX) opened 53 percent higher on the first day of trading. Read More
Tired of getting no satisfaction from the federal government, California is rolling out its own drug safety legislation to increase the oversight of sterile compounded drugs. Read More
SAN FRANCISCO – While the focus of the BIO Investor Forum was mainly on partnering and venture investment, no subject sparked more conversation and more interest than the exploding initial public offering (IPO) market and enabling provisions of the JOBS Act. Read More
LONDON – It is now possible to measure the activity of a multitude of genes in thousands of cells at once. The new method means that researchers will be able to rapidly detect differences in gene activity among the many cells of a tumor, for example, or among those of a tissue, whether healthy or diseased. Read More
• Evotec AG, of Hamburg, Germany, disclosed a second research collaboration, Target EEM (Enteroendocrine Mechanisms), with the laboratory of Doug Melton at Harvard University. Read More
• Genmab A/S, of Copenhagen, Denmark, reported top-line results from a Phase II study of the subcutaneous formulation of ofatumumab in relapsing-remitting multiple sclerosis (RRMS). Read More
• Teva Pharmaceutical Industries Ltd., of Jerusalem, said it will accelerate an ongoing global restructuring program by reducing its global work force by approximately 10 percent, or approximately 5,000 employees, and will complete the majority of cost reductions by the end of 2014. Read More
• Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said the China Food and Drug Administration accepted its application for clinical trial approval of pirotinib. In preclinical studies, the second-generation inhibitor, aimed at the treatment of lung and breast cancer, demonstrated beneficial profiles in pharmacology, pharmacokinetics and toxicology. Read More
