BioSpace News Archive

Merck announced the U.S. Food and Drug Administration has accepted for priority review a new supplemental Biologics License Application seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy as treatment with definitive intent for newly diagnosed patients with high-risk locally advanced cervical cancer.

Regulus Therapeutics Inc. today announced positive topline results from the first cohort of patients in its Phase 1b MAD study of RGLS8429 for the treatment of ADPKD.

Galvanize Therapeutics, Inc. today announced the treatment of the first patient in the AFFINITY clinical study.

Seelos Therapeutics today announced top line data demonstrating clinically meaningful treatment effects across multiple endpoints and a well-tolerated safety profile from the double-blind, placebo-controlled cohort (Part 2) of its Phase II study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD).

Rezo Therapeutics today announced the appointment of Nadir Mahmood, Ph.D., as chief executive officer and board member.

Danimer Scientific, Inc. (NYSE: DNMR) (“Danimer” or the “Company”) today announced it is expanding its collaboration with Chevron Phillips Chemical (“CPChem”) to explore development and commercialization of cast extrusion films, blown extrusion films, injection molded parts and rotational molded parts using Rinnovo™ polymers produced in a loop slurry reactor process.

Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that executive management will participate in a fireside chat at the Cantor Global Healthcare Conference on Wednesday, September 27, 2023, at 3:00 p.m. ET.

Oxford Biomedica plc announces interim results for the six months ended 30 June 2023.

Tourmaline Bio, Inc. today announced the appointment of Gerhard Hagn, PharmD, to the newly created role of SVP, Head of Commercial and Business Development.

NewAmsterdam Pharma Company N.V. today announced that Michael Davidson, M.D., chief executive officer of NewAmsterdam Pharma, will participate in a fireside chat at the 2023 Cantor Fitzgerald Global Healthcare Conference on Wednesday, September 27, 2023 at 1:50 p.m. ET.