BioSpace News Archive

Across a range of indications, COVID-19-related and non-COVID-19-related, there was plenty of clinical trial news last week.

The FDA has a full PDUFA calendar for the second half of March for New Drug Applications and Biologics License Applications. Here’s a look.

Scholar Rock, a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, announced that it will present a poster at the 2022 Muscular Dystrophy Association Clinical & Scientific Conference.

Everest Medicines announced that it has entered into a license agreement with Calliditas Therapeutics AB to develop and commercialize NEFECON for the treatment of primary IgA nephropathy in South Korea, expanding its license in addition to rights held in Greater China and Singapore.

IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, announced the successful completion of its Series D1 financing.

NeuBase Therapeutics, Inc., a biotechnology platform company Drugging the Genome™ to address disease at the base level using a new class of precision genetic medicines, announced new preclinical data for its lead development candidate, NT-0231.F, to treat myotonic dystrophy type 1.

Ascletis Pharma Inc. announces that it has further expanded its ritonavir oral tablet production capacity to approximately 530 million tablets per year, to meet the potential escalation in the domestic and global demands.

Ascendis Pharma A/S announced that top-line data from the randomized, double-blind, placebo-controlled portion of its Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism demonstrated statistically significant improvement with TransCon PTH compared to control on the primary composite endpoint and all key secondary endpoints.

CanSino Biologics Inc. announced that medRxiv, a preprint platform for preliminary biomedical research, published an academic paper1 on the efficacy of CanSinoBIO’s Recombinant COVID-19 Vaccine as a heterologous booster against the Omicron variant.