The FDA has issued new risk classification orders for two series of products, including in vitro diagnostics for hepatitis C, two of which the agency down-regulated from class III to class II. However, blood lancets for multiple uses on more than one patient has been elevated from class I to class III, a change that has no impact on any products currently available on the U.S. market.

Aligos Belgium presented research on ALG-005398, a first representative of a series of non-heteroaryldihydropyrimidines (HAPs) class I capsid-assembly modulators, that was identified using structure-based drug design and scaffold hopping.

Antios Therapeutics Inc. followed up its $96 million series B financing in April with another $75 million series B-1 round that reflects faith in the potential of lead candidate ATI-2173, bound for phase IIb investigation as the backbone of a once-daily, curative regimen in chronic hepatitis B virus (HBV) infection.

If there is one thing that potently illustrates the hope and despair of the COVID-19 pandemic, it is the zigzag of BioWorld’s Infectious Disease Index. Up by nearly 64%, it is towering over both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are up 12.4% and 15.5%, respectively, but it has experienced several downward swings this year as well.

After seeing elevated alanine transaminase (ALT) levels consistent with drug-induced hepatotoxicity in its phase II study of ABI-H2158, Assembly Biosciences Inc. decided to discontinue development of the chronic hepatitis B virus (HBV) infection therapy.

Brii Biosciences Ltd. raised HK$2.482 billion (US$319 million) in its IPO in Hong Kong and will use the proceeds to support the development of its key assets, which includes programs for hepatitis B virus (HBV), HIV and drug-resistant infections.

ISA Pharmaceuticals BV has closed a €26 million (US$30.76 million) funding round to advance its cancer immunotherapy product, ISA-101b, in the clinic, as the company aims to tackle the low response rates that hold back this therapeutic approach.

Arbutus Biopharma Corp. this month gained the go-ahead from regulators to start a phase Ia/Ib trial with its oral capsid inhibitor, AB-836, for the treatment of chronic hepatitis B virus (HBV) infection, an event that drew more attention to the busy space and brought renewed speculation about RNAi bids against HBV, including Arbutus’ own.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.