The Scottish health technology appraisal body also OKd Janssen's Ponvory and new indications for AstraZeneca’s Tagrisso, Roche’s Tecentriq and MSD’s Keytruda. It also said it could not make recommendations on a number of drugs because manufacturers had not made a submission to the SMC.
In its latest raft of advice, the Scottish Medicines Consortium (SMC), Scotland’s health technology appraisal body, has accepted UCB’s potential mega blockbuster psoriasis drug Bimzelx (bimekizumab) for use on the Scottish National Health Service following a fast-track process.
The SMC made a restricted recommendation for Bimzelx for plaque psoriasis patients who have failed to respond to standard systemic...
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
