Regulation

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

“It's kind of a free for all,” says longtime FDA funding advocate Steven Grossman. FDA knew funding it requested “was totally inadequate to the needs. So, Food Chemical Safety is stuck there with about six or eight other purposes the money could have been used for.

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

The European Medicines Agency is re-evaluating the marketing application for Aplidin. The initial application was rejected in 2018, but that rejection was revoked last year following a court case for another company’s drug that clarified impartiality requirements for experts consulted by the EMA.

Complaints from UK originator association the ABPI over rising payments required by the country’s voluntary scheme for branded medicines pricing have been denounced by the BGMA, which says the differentiated scheme is “delivering precisely as it was intended.”

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

Preliminary registration data released by FDA offers a first glimpse of the Modernization of Cosmetics Regulation Act’s impact on information the agency has at hand.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.