Xencor Inc.'s broadly enabling platform made possible "the calculated trade-off" by Novartis AG that let his bispecific antibody firm hang onto U.S. rights for its pair of lead compounds in a deal that could be worth as much as $2.4 billion-plus, CEO Bassil Dahiyat told BioWorld Today. Read More
Gilead Sciences Inc. landed an on-schedule FDA approval for the chronic hepatitis C virus (HCV) drug Epclusa, the first drug effective against all six major genotypes of the virus. The fixed-dose combination tablet contains both the active ingredient of Sovaldi (sofosbuvir) and the new NS5A inhibitor velpatasvir. Read More
DUBLIN – Shares in Celyad SA fell 40 percent in Brussels Tuesday on news that its C-Cure stem cell therapy failed to reach the primary endpoint of a phase III trial in patients with congestive heart failure. Read More
LONDON – The prospects of developing an effective Zika vaccine are improving, with the first report of effective immunization in a mouse challenge model, and data from the first nonhuman primate model of Zika showing that infection confers subsequent immunity. Read More
A serious new case of jaundice that developed during a Regulus Therapeutics Inc. study of RG-101 for the treatment of chronic hepatitis C virus (HCV) triggered the FDA to issue a verbal clinical hold on the program, sending company shares (NASDAQ:RGLS) down 49.3 percent to $2.54 on Tuesday. Read More
Despite congressional demands that CMS withdraw a controversial Part B demonstration model, the agency seems bent on finalizing the rule that would establish the nationwide experiment, possibly with some tweaks. Read More
NEW DELHI – Working with a U.S. partner, one of India's most active biopharma companies, Biocon Ltd., is moving forward on late-stage trials for a drug aimed at treating a common eye disorder for which there is no marketed treatment. Read More
Xbiotech Inc., of Austin, Texas, entered an exclusive licensing agreement with Megapharm Ltd., of Raanana, Israel, to commercialize Xilonix in Israel for the treatment of advanced colorectal cancer. Read More
Aytu Bioscience Inc., of Englewood, Colo. said clinical data for Natesto (testosterone), a nasal gel approved as a replacement therapy for men diagnosed with hypogonadism, has shown that the pharmacokinetics, safety and efficacy of Natesto for restoring normal testosterone levels in men with low testosterone levels is not adversely affected by seasonal allergies. Read More
As part of the U.S. cancer moonshot, the Patent and Trademark Office is implementing a one-year pilot program Wednesday to provide for earlier review of patent applications pertaining to cancer immunotherapy. To qualify for the 12-month review, applications must claim a method of treating a cancer using immunotherapy, and the applicant must file a grantable "petition to make special" before June 29, 2017. Read More
