BioSpace News Archive

Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer.

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited (SK bioscience), a biotechnology company in South Korea, today announced the submission of a Biologics License Application (BLA) for Novavax’ COVID-19 vaccine to South Korea’s Ministry of Food and Drug Safety (MFDS).

Zimmer Biomet Holdings, Inc. announced the commencement of tender offers to purchase for cash any and all of its 3.700% Senior Notes due 2023 and up to $1.5 billion aggregate purchase price of its 3.550% Senior Notes due 2025, 3.550% Senior Notes due 2030, 4.450% Senior Notes due 2045, 3.050% Senior Notes due 2026, 4.250% Senior Notes due 2035 and 5.750% Senior Notes due 2039.

Penrose TherapeuTx, a privately held clinical stage small molecule drug development company committed to improving patient lives through innovative oncology therapies, today announced the appointment of David Sherris, Ph.D. as President and Chief Executive Officer.

Altamira Therapeutics Ltd. announced the presentation of data from two studies by a research group at Washington University, St. Louis, MO, on the use of the Company’s RNA delivery platforms for extrahepatic nucleotide delivery in the treatment of abdominal aortic aneurysm at the American Heart Association Scientific Sessions, taking place on November 13-15, 2021.

OmniVision Technologies, Inc., a leading developer of advanced digital imaging solutions, and Diaspective Vision GmbH, developer of high quality hyperspectral and multispectral camera systems for medical applications, announced their partnership in the development of a new type of endoscopic camera, the MALYNA system, which is based on proprietary multispectral imaging technology.

Humacyte, Inc. announced that data from a Phase 2 clinical trial of patients receiving the human acellular vessel produced using its cutting-edge, large-scale manufacturing systems, known as “LUNA200”, for vascular access in hemodialysis, demonstrated 12-month efficacy that is similar to trials of HAVs produced in the development-scale systems previously used in manufacturing the HAV.

MimiVax LLC, a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, announced today that the company has received a “Study May Proceed” notification from the United States Food and Drug Administration (FDA) to begin a Phase 2b trial, for SurVaxM in newly diagnosed glioblastoma entitled “SURVIVE.”

PathAI, a global leader of AI-powered technology, today announced results showing that scoring of NASH histopathological features in phase 3 clinical trials is highly concordant within a panel of 3 expert hepatopathologists and between two independent panels.

The U.S. Food and Drug Administration is taking several important actions to support ongoing nationwide COVID-19 testing efforts.