As the fairness of orphan drug exclusivities is debated in Congress, the U.S. Food and Drug Administration granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
Jada Pinkett Smith, via her husband Will Smith’s much-discussed slap of Chris Rock following a joke about her hair loss at the 2022 Academy Awards, has again shone a bright spotlight on the autoimmune disease alopecia areata.
Pfizer announced positive top-line results from the company’s year-long Phase III trial of etrasimod for the treatment of ulcerative colitis (UC). Pfizer plans to pursue regulatory filings for the drug during 2022.
Seattle-based Icosavax’s stock plunged more than 60 percent on March 25 after the company reported topline interim data from its ongoing Phase I/II COVID-19 vaccine trial.
Sanofi and partner Swedish Orphan Biovitrum shared positive topline results from their ongoing Phase III trial on a candidate drug for patients diagnosed with severe hemophilia A.
Astellas Pharma Inc. announced topline results from the Phase 3 SKYLIGHT 4 clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions.
The U.S. Food and Drug Administration accepted for review Pfizer Inc.’s Prior Approval Supplement to the Biologics License Application for ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).
AbbVie reported the company’s fourth-quarter 2021 and full-year financial results on Feb. 2, with worldwide net reviews up 7.4% to $14.89 billion for the quarter. Total revenues for 2021 were $56 billion. The company’s anchor product remains Humira, which will begin to lose exclusivity in 2023.
New York-based Anavex Life Sciences announced positive topline results from the company’s Phase III AVATAR trial of Anavex 2-73 (blarcamesione) in adult female patients with Rett syndrome.
Shares of Madrigal Pharmaceuticals went up in trading after the company announced positive topline data from a Phase III assessment of resmetirom in non-alcoholic fatty liver disease.