FDA, stop sign

The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.

Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.

The U.S. FDA approved AbbVie Inc.’s Skyrizi as a treatment for plaque psoriasis at a time when the company’s blockbuster psoriasis medicine Humira faces patent pressures.

Eli Lilly and Co. said the company’s psoriatic arthritis (PsA) drug Taltz was found to be more effective than the world’s best-selling prescription medicine, AbbVie Inc.’s Humira, in a late-stage study.

Johnson & Johnson said the company’s drug Tremfya was more effective than Novartis AG’s rival medicine Cosentyx, and met the main goal of a late-stage study in adults with moderate-to-severe plaque psoriasis.

Bausch Health, formerly Valeant Pharmaceuticals, received tentative U.S. approval to market the plaque psoriasis lotion Bryhali.

Eli Lilly and Company announced today the initiation of the IXORA-R head-to-head clinical trial, designed to evaluate superiority between Taltz (ixekizumab) and Tremfya (guselkumab) in adult patients with moderate-to-severe plaque psoriasis.

Months after tapping GlaxoSmithKline dermatology division executive David Rubenstein as its new chief scientific officer, Vivek Ramaswamy’s Dermavant Sciences returned to the pharma giant to acquire a Phase III-ready psoriasis treatment.

Valeant Pharmaceuticals International Inc.’s plaque psoriasis treatment did not get approval from U.S. health regulators.

Novartis’ generics unit won a European panel’s recommendation for its biosimilar version of AbbVie’s Humira as the Swiss drugmaker aims to take a bite out of sales of the world’s best-selling medicine.