After earlier this month announcing promising new data supporting its genetic treatment for hepatitis B, Arrowhead Research is moving forward with the candidate, submitting its application to begin a Phase IIa trial of ARC-520, which uses its polymer-based method to effectively deliver RNAi to the nucleus.
RNA delivery specialist Arrowead Research heralded new data supporting its genetic treatment for hepatitis B, which makes use of the company's polymer-based method for effectively getting RNAi to the nucleus. And its immunological response offers what could be a "functional cure" for the disease.
Lately, there's been a lot of scrutiny surrounding preclinical research. Last year, a former researcher at Amgen ($AMGN) found that many basic cancer studies--published in leading science...
Medivir, which is partnered with Johnson & Johnson on the late-stage hep C drug simeprevir, said it has discontinued the development of its hepatitis B compound MIV-210 based on a joint decision with South Korean collaborator Daewoong Pharmaceutical.
In Asia Pacific viral hepatitis kills one person every 30 seconds. This creates a huge opportunity for vaccines from GlaxoSmithKline, Merck and others to improve public health, yet a lack of national action plans is restricting the impact of these preventative measures.
Dynavax saw its share price tumble in November after FDA advisers suggested its hepatitis B vaccine needed more data to support approval. FDA rejection followed in February, sending shares down still further. Now the stock has dropped for a third time.
Shares of Dynavax Technologies took a fresh dive this morning after the biotech announced the FDA had provided some fresh insights into the safety data it wants to see before it can approve the hepatitis B vaccine Heplisav, likely adding to the delay before the biotech can try again in seeking an approval.
A new small molecule developed by Gilead Sciences has shown encouraging results in preclinical studies against hepatitis B--an infectious inflammatory illness of the liver caused by the virus of the same name--and is quickly moving toward the clinic.
After rejecting Dynavax's ($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.