BioSpace News Archive

Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

Merck (NYSE: MRK) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

Annexon, Inc. (Nasdaq: ANNX) today reported results from the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) healthy volunteer study of ANX1502, a first-in-kind oral, selective small molecule inhibitor that targets the active form of C1s responsible for propagating classical pathway activation in association with C1q.

Northwell Health and the Feinstein Institutes for Medical Research’s Christina Brennan, MD, senior vice president of clinical research, has received the Clinical Trial Europe’s Christine Pierre Clinical Trials Lifetime Achievement Award for her dedication to leading innovative, equitable and clinically meaningful clinical trials throughout her career and particularly her leadership in rolling out some of the first national COVID-19 clinical trials in 2020.

Annexon, Inc. announced the pricing of an underwritten public offering of 25,035,000 shares of its common stock and pre-funded warrants to purchase 18,379,861 shares of common stock.

Voom™ Medical Devices, Inc. (“Voom”), a trailblazing orthopedic medical device company and pioneer in minimally invasive bunion surgery (MIBS) solutions, proudly announces the debut of www.Bunionplasty.com.