Tag:

hepatitis B

Latest Headlines

Latest Headlines

Arrowhead submits IND for its RNAi-based hep B candidate

Arrowhead Research Corporation is looking to add another entrant into the clinical trial-based race to commercialize the first  RNAi-based  compound, a market category that could become a new class of drugs akin to monoclonal antibodies and produce revenues exceeding $1 billion by 2020 according to one projection.  The company recently announced that it has submitted its Investigational New Drug application for its  RNAi  candidate, ARC-520, for the treatment of the chronic hepatitis B virus.

Alnylam adds two RNAi programs to its hepatitis pipeline

Alnylam today announced the addition of RNA interference therapies for the hepatitis delta virus and chronic liver infections to its clinical pipeline at the American Association for the Study of Liver Diseases in Boston. The company also said it remains on track to select a candidate for its hepatitis B program by the end of the year and hopes to file an investigational new drug application with the FDA in late 2015. 

Arrowhead tanks as its hep B treatment disappoints in Phase II

Arrowhead Research watched its shares nose-dive after a peek at Phase II data on its in-development treatment for hepatitis B revealed that the RNAi therapy isn't measuring up to its preclinical promise.

Arrowhead updates TheStreet on clinical trial results of RNAi candidate for hepatitis B

Arrowhead Research reported on Aug. 12 that patients in its Phase II clinical trial of the ARC-520 RNA interference candidate for hepatitis B had a "similar" knockdown to those reported in primate studies. The stock price fell at the very end of the trading day to close at $12.00 from an opening-day price of $13.00.

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.