Roche’s Xofluza brings novel approval count for CDER to 47, topping 2017's record – and FDA still has at least 14 novel agents under review with 2018 goal dates.
With two months remaining in 2018, the US FDA’s drug center has already exceeded last year’s record approval count, with no signs of a slow-down on the horizon.
Shionogi & Co. Ltd. and Roche’s Xofluza became the forty-seventh novel agent cleared this year by the Center for Drug Evaluation and Research with its Oct. 24 approval...
Now an even longer-standing record is under threat: the historical high of 53 new molecular entities approved in 1996. (See graph below.)
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
