1. Pink Sheet

Busy Days For Hep B Drug Development

Activity in the hepatitis B field is heating up, as evidenced by recent announcements from J&J, Gilead and Dynavax.

Johnson & Johnson isn't the only biopharma looking to make gains in the treatment of hepatitis B, which is addressed currently with existing nucleotide analogue therapies such as Viread (tenofovir disoproxil fumarate). Gilead Sciences Inc. has been advancing a new formulation of tenofovir for both HIV and HBV, and filed tenofovir alafenamide (TAF) for approval as a once-daily, 25 mg treatment for chronic HBV at FDA on Jan. 12.

TAF is a prodrug of the maturing Viread, and is part of one already-filed combination therapy candidate for HIV, as...

More from Archive

More from Pink Sheet

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.