FDA and EMA requests for more data on hepatitis B candidate Heplisav have set Dynavax Technologies back time and again. Now, Dynavax is embarking on a new trial it hopes will address some of those safety concerns.
Arrowhead, fresh off a $120 million public offering in February, is paving the way on what it has called a "functional cure" for hepatitis B, beginning dosing in a Phase IIa trial for its RNAi drug designed to deliver the genetic material to the nucleus using a polymer-based conjugate.
Last week research firm GlobalData tipped the hepatitis B vaccine market to top $1 billion by 2022, with sales of Sanofi's Hexyon driving the sector's modest growth. Dynavax hopes to claim a slice of the market too, but its hepatitis B vaccine received another blow this week.
The National Adult Vaccination Program and others have proposed strategies to raise the proportion of adults getting vaccinated against pneumococcal disease, shingles and hepatitis B, but the latest data shows little change in immunization rates.
The start of 2014 has been a tumultuous period for Chinese manufacturers of hepatitis B vaccines, with three leading producers failing to gain quality certificates and authorities investigating 17 baby deaths. This week, China reassured its population there is no link between the vaccine and the deaths, but a history of cover-ups mean people are still suspicious.
China's push to raise manufacturing standards was always likely to result in a few hiccups as companies raced to bring production plants into line with new regulations. And with the deadline for producers of injectables now having passed, it appears the hepatitis B vaccine market faces a tricky few months.
After earlier this month announcing promising new data supporting its genetic treatment for hepatitis B, Arrowhead Research is moving forward with the candidate, submitting its application to begin a Phase IIa trial of ARC-520, which uses its polymer-based method to effectively deliver RNAi to the nucleus.
RNA delivery specialist Arrowead Research heralded new data supporting its genetic treatment for hepatitis B, which makes use of the company's polymer-based method for effectively getting RNAi to the nucleus. And its immunological response offers what could be a "functional cure" for the disease.
Lately, there's been a lot of scrutiny surrounding preclinical research. Last year, a former researcher at Amgen ($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.