Here are the latest stories being discussed in biopharma today:

New Drug Approvals Reach Five-Year High

In 2023, the FDA approved 57 novel drugs, marking the highest total since 2018. Notably, December saw the approval of two new gene therapies for sickle cell disease, including the first-ever CRISPR-based treatment in the U.S., Vertex and CRISPR Therapeutics’ Casgevy.

GSK Resizes Scynexis Deal

Scynexis will receive less money in a multimillion-dollar licensing contract with GlaxoSmithKline, due to a delay in commercializing its antifungal drug. Scynexis will receive regulatory approval milestone payments of up to $49 million, commercial milestone payments of up to $57.5 million, and sales milestone payments as low as $145.5 million.

Zero FDA Drug Meetings Scheduled for 2024

The FDA has not yet scheduled any drug or biologic meetings for 2024. The lack of advisory committee meetings (adcomms) for controversial drug approval decisions hints at potential upcoming reforms.

Pfizer Gene Therapy Approved in Canada

Pfizer has received approval for its gene therapy for hemophilia B in Canada, ahead of an expected decision in the US. This sets the stage for competition with CSL Behring’s gene therapy Hemgenix, which received approval in the US and Canada in 2022.

Daiichi Sankyo and Esperion Settle Lawsuit

A $125 million amendment have settled a legal dispute between Daiichi Sankyo Europe and Esperion Therapeutics. Daiichi Sankyo will pay Esperion $100 million this month, plus an additional $25 million following the EMA’s decision on the pending application for two cardiovascular drugs.

Novo Nordisk Expands European Manufacturing

Novo Nordisk has acquired an 85-acre plot of land near Dublin, with the intention of boosting its manufacturing footprint in Europe. Pending approval, the facility would produce medication for metabolic diseases.

Biden Administration to Utilize Defense Production Act

The Biden administration plans to employ the Defense Production Act to tackle drug shortages, however, the specific drugs and treatments in question are currently undisclosed.

Israeli Embassy Meets with FDA

The FDA has scheduled a meeting with the Israeli embassy to discuss the potential establishment of a new Middle East office. The main discussion topics are yet to be disclosed.

MASH Therapies in Focus at Boehringer Ingelheim

Boehringer Ingelheim is reportedly turning its focus to RNAi for new MASH therapies. The investigations pertain to certain metabolic diseases, inflammatory disorders, and liver conditions.