BioSpace News Archive

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Mirum Pharmaceuticals, Inc. announced that on December 9, 2022, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 38,200 shares of common stock and 19,100 restricted stock units to seven new employees under Mirum’s 2020 Inducement Plan.

UCB, a global biopharmaceutical company, today announced positive top-line results from two Phase 3 studies, BE HEARD I and BE HEARD II, evaluating the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa.

Regulatory News: Aptorum Group Limited today announced a private offering of USD$3 million aggregate principal amount of convertible note due 2023 (the “Note”) to be used as part of the Company’s daily operations and clinical program.

BeiGene, a global biotechnology company, is convening diverse stakeholders to amplify the mental health needs of the cancer community during an event hosted for patient advocates and scientists attending the American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans.

Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.

Erasca, Inc. (Nasdaq: ERAS) today announced it has entered into an exclusive worldwide license agreement with Novartis (NYSE: NVS) for naporafenib, a Phase 2 pivotal-ready pan-RAF inhibitor with a potential first-in-class and best-in-class profile in NRAS mutant (NRASm) melanoma and other RAS/MAPK pathway-driven tumors.

Optinose, a pharmaceutical company focused on patients treated by ear, nose and throat and allergy specialists, announced that Michele Janis, Acting Chief Financial Officer, will leave Optinose to accept a CFO opportunity at a privately-held company.

Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative targeted therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, shared two poster presentations at the 2022 San Antonio Breast Cancer Symposium evaluating the results of an online survey of ER+/HER2- metastatic breast cancer patients.

Takeda (TSE:4502/NYSE:TAK) today announced that it will present 15 company-sponsored abstracts at the 64th American Society of Hematology (ASH) Annual Meeting being held December 10-13, 2022 in New Orleans.