BioSpace News Archive

Merck today announced the European Commission (EC) has approved two new indications for KEYTRUDA, Merck’s anti-PD-1 therapy, in gastrointestinal cancers.

Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’) today announced that the Company has transferred ownership, as of May 2023, of the existing U.S. Food and Drug Administration (FDA) New Drug Application (NDA) of the investigational MAP originally intended for the epidermal delivery of zolmitriptan1 (also known as M207) for the treatment of migraine attacks in adults.

Replay today announced a licensing and manufacturing agreement to support the development of a GMP-compliant T-cell receptor (TCR) natural killer (NK) cell therapy targeting the tumor-associated neoantigen, PRAME.

Achilles Therapeutics plc today announced publication of a ‘Comment’ in Nature Cancer that outlines the vast potential of neoantigen immunogenicity prediction, discusses current limitations in the field that limit performance, and proposes a path forward.

ICON plc, a world-leading healthcare intelligence and clinical research organisation, finishes the second half of 2023 with positive recognition as a top-rated employer and leader in clinical trial innovation.

RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331), a commercial-stage biotechnology company, has recently confirmed that under the 2023 simple renewal mechanism of China National Healthcare Security Administration (NHSA), on January 1, 2024, the updated National Reimbursement Drug List (NRDL) will continue to include Telitacicept (RC18) and Disitamab Vedotin (RC48) for the next two-year agreement.

Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today provided a comprehensive development program update for its highly selective oral GLP-1 receptor agonist, GSBR-1290.

Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire) announced today that its management team will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024.

Ultragenyx Pharmaceutical Inc. announced that the European Commission has extended the approval of Evkeeza® as an adjunct to diet and other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia.

Provectus (OTCQB: PVCT) today announced that the United States Patent and Trademark Office (USPTO) has allowed patent application 17/488,430, titled “Halogenated Xanthenes as Vaccine Adjuvants.”