A new small molecule developed by Gilead Sciences has shown encouraging results in preclinical studies against hepatitis B--an infectious inflammatory illness of the liver caused by the virus of the same name--and is quickly moving toward the clinic.
After rejecting Dynavax's ($DVAX) hepatitis B vaccine Heplisav for safety issues, the FDA said it will meet with the company in 6 weeks' time to discuss a more restricted use of the vaccine.
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.
NIH's National Institute of Allergy and Infectious Diseases has its eye on Altravax, awarding the company $1.2 million to advance a dengue vaccine and hepatitis B therapeutic.
Two weeks ago, an FDA panel dealt a blow to Dynavax Technologies, raising concerns about the safety of the company's hepatitis B vaccine, Heplisav. Shares dropped and investors tend to turn their backs on a company when stock prices go down. But is the company's future really all that grim?
An FDA panel dealt a blow to Dynavax Technologies on Thursday, raising concerns about the safety of the company's hepatitis B vaccine.
Dynavax Technologies ($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.
PerkinElmer ($PKI) has become a much bigger player in China's molecular clinical diagnostics market with the wrap-up of its $38 million acquisition of Shanghai Haoyuan Biotech Co.
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.