FDA advisors considering Linhaliq, an experimental Aradigm Corp. drug for a rare but severe respiratory disease in patients with chronic lung infections, declined to support a new drug application for it, citing inconsistent efficacy data and concern over the endpoint of pivotal trials. Read More
States are taking action to either sidestep the FDA or force it to rethink its regulations that keep drug and device companies from sharing truthful, scientific information about off-label uses of their products. Read More
DUBLIN – Oxford University spinout Vaccitech Ltd. raised £20 million (US$27.3 million) in a series A round that will enable it to complete an ongoing phase IIb trial of a universal influenza vaccine and a phase II trial of a therapeutic prostate cancer vaccine within the next two years. Read More
John Rice is a veteran of the annual J.P. Morgan Healthcare Conference (JPM), dating back to the days when it was known as Hambrecht & Quist. He's accustomed to the frenetic pace of the San Francisco event that kicks off the year for biopharma and, increasingly, for the larger life sciences universe. What's different from those early years is the number of costume changes he makes during the week as director of life sciences at Cincytech. Read More
Immunological memory was once considered the sole provenance of the adaptive immune system's T and B cells, while the adaptive immune system "was thought to respond in the same naïve way every time," Niels Riksen told BioWorld. Read More
Myriad Genetics Inc., of Salt Lake City, said the FDA approved BRACAnalysis CDx for use as a companion diagnostic by health care professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza (olaparib), marketed by Astrazeneca plc, of London, and Merck & Co. Inc., of Kenilworth, N.J. Read More
Exact Sciences Corp., of Madison, Wis., priced its underwritten public offering of 1 percent convertible senior notes due 2025, and upsized the offering from $500 million to $600 million. Read More
Rgenix Inc., of New York, disclosed the publication of clinical and preclinical results by research collaborators at Rgenix and the Rockefeller University. Read More
Aging is a major risk factor in most diseases. But much remains to be learned about how aging itself and age-associated diseases are coupled at the molecular level. Researchers from the Salk Institute for Biological Studies have identified a molecular link between aging and dementia through studies of the experimental compound J-147. Read More
