Immune Disorders

The European Medicines Agency has begun evaluating the EU marketing applications for a new batch of drugs, including products from Incyte, Sanofi and Novo Nordisk that target hidradenitis suppurativa, rabies and hemophilia A, respectively.

In 2024, trial initiations shifted following the post-pandemic decline in COVID-19 studies. Cardiovascular trials showed the greatest growth by therapeutic area but trailed the previous year’s initiation levels.

The Swiss major plans to submit the positive results from the NEPTUNUS program to health authorities globally in early 2026.

In this episode of the In Vivo podcast, Lupus Therapeutics' Stacie Bell discusses transforming lupus drug development through patient-centered clinical trials, promising new oral therapies and revolutionary cell therapy approaches.

A new report highlighting 62 key drug launches expected in 2026 includes five products that are predicted to hit a golden trifecta of being a first launch, having practice-changing potential and the promise of being a blockbuster.

Speakers at ARM’s Cell and Gene Meeting on the Mesa highlighted challenges of CAR-T’s evolution from niche to mainstream therapy given health care providers’ limited capacity to deliver the complex care associated with the products.

Alvotech has welcomed a trio of Japanese biosimilar approvals, set to be sold via its local commercial partner Fuji Pharma, though the firm remained tight-lipped about future potential launch dates.

Samsung Bioepis will not be able to add an ulcerative colitis indication to its ustekinumab biosimilar in the Netherlands for now, after failing to have a key patent revoked.

Chinese developer and manufacturer Bio-Thera Solutions has struck a further licensing agreement for one of its biosimilar candidates, this time for a proposed rival to Cosentyx (secukinumab).

The sponsors of seven new medicines nearing the end of their EU regulatory review are due – or possibly due – to appear before the European Medicines Agency’s human medicines committee, the CHMP, to address remaining concerns about their marketing applications.

Generics manufacturers are facing a decade-long wait to launch rivals to AbbVie’s blockbuster Rinvoq (upadacitinib) after settling patent-infringement litigation.

Phase IIa data for Dianthus’ complement C1s inhibitor claseprubart in myasthenia gravis showed strong efficacy, less frequent dosing and no risk of infections relative to a growing list of competing drugs.