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.

Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.

AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).

Global immunology firm Argenx shared positive topline results from the company’s ongoing study on the use of efgartigimod for generalized myasthenia gravis (gMG). 

Belgium-based UCB hit the mark in the company’s Phase III clinical trial assessing zilucoplan as a potential treatment for adults with generalized myasthenia gravis, a rare autoimmune disease. Vanda Pharmaceuticals’ late-stage study of tradipitant as a treatment for the symptoms of gastroparesis, a digestive disorder, failed to meet the trial’s primary endpoint.

The U.S. Food and Drug Administration approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients positive for anti-acetylcholine receptor (AChR) antibody.

Boston-based Alexion Pharmaceuticals announced positive topline data from the company’s Phase III trial of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis.

The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.

Top 10 Pipelines To Watch: 2019 Annual Report

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The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

Although the stock market seems to be moving up at the beginning of this year, the U.S. equities market appears more mixed, with healthcare stocks in particular appearing more volatile.