Medivir, which is partnered with Johnson & Johnson on the late-stage hep C drug simeprevir, said it has discontinued the development of its hepatitis B compound MIV-210 based on a joint decision with South Korean collaborator Daewoong Pharmaceutical.
Shares of Dynavax Technologies took a fresh dive this morning after the biotech announced the FDA had provided some fresh insights into the safety data it wants to see before it can approve the hepatitis B vaccine Heplisav, likely adding to the delay before the biotech can try again in seeking an approval.
Dynavax noted that regulators want to see further evaluation of safety in the broad age group of 18 to 70, pronouncing their concerns over the possibility of rare autoimmune events among patients taking the treatment and outlining questions on process validation and the manufacturing process.
French biotech Transgene has watched partnership prospects vanish for its experimental vaccine against hepatitis C over the past year, as all-oral regimens against the liver-damaging disease have quickly taken over as the future therapy of choice.
Dynavax Technologies ($DVAX) didn't get the safety nod it sought for its hepatitis B vaccine from FDA advisers Thursday, and its shares plummeted in extended trading. The Berkeley, CA-based biotech is seeking U.S. approval of the vaccine, Heplisav, which provides the developer its best shot at having a marketed product.
5AM Ventures and Canaan Partners have joined forces to lead a $23 million A round for a startup antiviral biotech based in Radnor, PA. Novira Therapeutics is developing capsid-targeting antivirals for hepatitis B and HIV.