Investors watching for signs of M&A activity from Gilead Sciences Inc. could be eyeing the big biotech even more closely after top-line phase II data revealed a missed primary endpoint for hepatitis B virus (HBV) contender GS-4774, prompting speculation that the Foster City, Calif.-based firm could tap other players to shore up its early but promising HBV pipeline. Read More
SAO PAULO, Brazil – A group of 11 Latin American countries has taken a significant step toward unifying their drug regulations by allowing for a single registration. Read More
When drug developers ponder how to get across the blood-brain barrier, it is more often within the context of how to get things into the brain. But new research suggests that in Alzheimer's disease, one of the issues is that amyloid-beta can't cross in the other direction and get out of the brain. Read More
What do the Boston Marathon bombing and the Ebola epidemic have in common? The lessons learned in responding to the attack and the viral epidemic will help advance medical countermeasures (MCMs) and future emergency responses. Read More
The FDA's Mark Witkowski yesterday reviewed recent developments at the agency in the area of field detection technologies, and in the process, put counterfeiters on alert that enforcement can be instantaneous with the observation, "no longer do you have a time delay between sample collection and reporting results" for suspect pharmaceutical products. Read More
Enanta Pharmaceuticals Inc., of Watertown, Mass., said new data from North Chicago-based Abbvie Inc.'s phase III Gift-I study, its all-oral, interferon- and ribavirin-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir, were presented at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan. Read More
Halozyme Therapeutics Inc., of San Diego, and Ventana Medical Systems Inc., a member of the Roche Group, of Basel, Switzerland, inked a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20. Read More
Rani Therapeutics LLC, of San Jose, Calif., said it closed its series C round of funding, with participants including Basel, Switzerland-based Novartis AG, along with Google Ventures, Incube Ventures and Venturehealth. Read More
