Dermatology

Sun launches tildrakizumab, its star psoriasis therapy in India seven years after US FDA approval at what’s seen as a carefully calibrated price point. Can it ruffle entrenched products like secukinumab?

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.

While the European Medicines Agency’s human medicines committee voted in favor of EU approval for 10 new products, it reaffirmed its previous decision not to grant Aqneursa new active substance status.

Daily Niagen use increased NAD+ levels for subjects in long-COVID study, showing “encouraging within-group improvements” in fatigue, sleep and mood. Tru Niagen Beauty is “cellular-first formula designed to support skin elasticity and the appearance of hair, skin, and nails.”

Sales of Zoryve comfortably exceeded consensus in the third quarter and both the foam and cream formulations are selling well across its dermatological indications.

The US biotech has raised $300m to advance its atopic dermatitis candidate towards Phase III trials next year.

The Swiss group is more than holding its own against Dupixent for prurigo nodularis and is looking to make further inroads into Sanofi and Regeneron's blockbuster's market share in atopic dermatitis.

Celltrion has won the race to launch the first biosimilar to Novartis/Roche’s blockbuster treatment for chronic spontaneous urticaria and severe persistent allergic asthma in Europe.

Ascletis presented updated results at EADV showing denifanstat could significantly improve acne conditions versus placebo in Chinese patients after four weeks of treatment.

Cessatech and Proveca’s investigational, sufentanil/ketamine fixed-dose combination analgesic nasal spray is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.

The European Medicines Agency says that Winlevi should be approved in the EU for treating acne, having previously turned the drug down.

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.