BioSpace News Archive

The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.

The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.

The Centers for Medicare & Medicaid Services announced Friday it will impose inflation penalties on 43 Medicare Part B drugs in the third quarter of 2023. The action follows fines on 27 drugs in March.

The company paid $85 million upfront to Quell Therapeutics to develop Treg therapies for Type 1 diabetes and inflammatory bowel disorder, with the deal potentially worth more than $2 billion.

Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.

Unlimited paid time off may seem like a way to prevent burnout, but for many, it has the opposite effect.

Astellas Pharma Inc. announced the submission of a New Drug Application on June 9, 2023 to Japan’s Ministry of Health, Labour and Welfare for zolbetuximab, a first-in-class investigational Claudin 18.2 -targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.

Quell Therapeutics Ltd announced that it has entered into a collaboration, exclusive option and license agreement with AstraZeneca to develop, manufacture and commercialize autologous, engineered Treg cell therapies for two autoimmune disease indications.

Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, will be hosting a company-sponsored symposium entitled “Patient’s perspective: A must have for the future of Allergen Immunotherapy” at the 2023 European Academy of Allergy and Clinical Immunology Congress taking place June 9-11 in Hamburg.

Astellas Pharma Inc. and the Blood and Marrow Transplant Clinical Trials Network presented data from the Phase 3 MORPHO clinical trial which demonstrated favorable results in subgroups of FMS-like tyrosine kinase 3 -internal tandem duplication mutated acute myeloid leukemia patients, including a subgroup of patients with detectable measurable residual disease.