Drug Review

Ahead of the first biosimilars to denosumab emerging later in the spring, the market is continuing to prove enticing, with Amneal the latest to file for biosimilars to Prolia and Xgeva.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Having picked up Niemann-Pick disease type C drug Miplyffa for a song, the US rare disease specialist is singing all the way to the bank after selling the priority review voucher that came with its approval.

Like the layoffs, the reason for the recalls of some laid off CDER and Office of Chief Counsel staff remains unclear.

Etuvetidigene autotemcel, Fondazione Telethon’s investigational gene therapy for Wiskott-Aldrich syndrome, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

“While Vanda developed the brand-name drugs, the trade secret and confidential and proprietary information claimed to have been taken by the government was, in fact, proposed and recommended to Vanda by the FDA,” a US federal court said.

“While Vanda developed the brand-name drugs, the trade secret and confidential and proprietary information claimed to have been taken by the government was, in fact, proposed and recommended to Vanda by the FDA,” a US federal court found as it granted summary judgment to the US government.

The injection for radicular leg pain appears likely to be approved, but with a very prescriptive label to help balance safety concerns and a lack of long-term outcomes data.

The drug maker announced positive topline Phase III results for its subcutaneous PD-1 inhibitor sasanlimab in first-line, BCG-naïve non-muscle invasive bladder cancer combined with BCG.

ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA’s competitive generic therapy pathway.