Tag:

hepatitis B

Latest Headlines

Latest Headlines

FDA warns Gilead over 'misleading' paid search link

The drug is approved for treating--not preventing--hepatitis B, prompting FDA to call the advert misleading.

Animal model that mimics hep B, C in humans could spur new treatments

To help design next-generation drugs for hepatitis B and C, researchers have developed a humanized mouse model that contains human liver cells and mimics the immune system of people.

UPDATED: Alnylam's hepatitis B therapy shows promise in animal studies

RNAi specialist Alnylam is adding a hepatitis B virus therapy to its pipeline of candidates that employ its Enhanced Stabilization Chemistry-GalNAc-conjugate technology enabling subcutaneous dosing and plans to file an IND by the end of 2015.

Dynavax initiates PhIII study it hopes will quell FDA's safety concerns

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 doses first RNAi hepatitis B 'functional cure' PhIIa patient

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.

Dynavax's hep B vaccine plans derailed by European request for extra safety data

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.

CDC: Adult vaccination rates are still well below targets

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.

China gives hep B vaccine a clean bill of health but suspicions remain

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.

New Chinese quality standards raise the risk of a hep B vaccine shortage

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.

Arrowhead submits PhIIa application for hep B RNAi candidate

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.