BioSpace News Archive

The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.

Approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, CorMedix’s DefenCath reduces the incidence of catheter-related bloodstream infections in adult hemodialysis patients.

The Japanese pharma contends that an analysis of the four deaths in its AT132 gene therapy clinical trial shows it is still viable as a potential treatment for a fatal, rare genetic disease.

BioSpace takes a deep dive into five investigational therapeutic cancer vaccines that have recently shown efficacy in difficult-to-treat indications.

Just a week after it secured FDA approval, Eli Lilly’s Zepbound now faces a challenge from Novo Nordisk’s investigational next-generation weight-loss candidate CagriSema in a Phase III trial.

After Bristol Myers Squibb picked up Augtyro as part of its $4.1 billion takeover of Turning Point Therapeutics last year, the ROS1-positive non-small cell lung cancer drug reached the regulatory finish line on Wednesday.

Antengene Corporation Limited (“Antengene” SEHK: 6996.HK) is presenting encouraging clinical data of the Company’s four key drugs in clinical development: ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (oral CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor), at its 2023 R&D Day taking place today.

Astellas Pharma Inc. and Pfizer Inc. announced that the companies received an approval by the U.S. Food and Drug Administration of a supplemental New Drug Application for XTANDI®, following FDA expedited development and review programs, based on results from the Phase 3 EMBARK trial.

On November 16, the Canadian Medical Isotope Ecosystem (CMIE) - an initiative co-led by TRIUMF Innovations and the Centre for Probe Development and Commercialization

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostics technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that members of its management team are scheduled to participate in the Evercore ISI conference in Miami, FL, on November 30, 2023.