Cambridge-based Seres Therapeutics and Nestlé Health Science have announced FDA approval of Vowst, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). Vowst was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA. Recurrent CDI represents significant unmet need and is a leading cause […]

RNA medicines developer Orbital Therapeutics has announced the successful closing of $270 million Series A financing. Orbital Therapeutics is focused on expanding the applicability of RNA-based medicines across a range of human diseases, including in the areas of next-generation vaccines, immunomodulation, and protein replacement. “Few companies can possess the know-how, technology and biologic insights to […]

The FDA has granted Biogen conditional approval for antisense oligonucleotide Qalsody (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the SOD1 (superoxide dismutase 1) gene, producing a rare, hereditary form of the disease. Qalsody is the first approved treatment to target a genetic cause of ALS. Tofersen was […]

Moderna and Merck have announced positive results from the Phase 2b trial evaluating Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda in patients with high-risk melanoma. The study demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival and reduced the risk of recurrence or death by 44% compared with Keytruda alone. mRNA-4157 (V940) […]

Takeda has announced positive results from a Phase 2b clinical trial of a tyrosine kinase 2 (TYK2) inhibitor in patients with moderate-to-severe plaque psoriasis, meeting its primary and secondary endpoints compared to placebo. “We are confident that we can execute a comprehensive development program and deliver a potential best-in-class therapy for patients, given Takeda’s strong background […]

Novartis has announced positive topline results from an interim analysis of a Phase 3 trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in patients with a form of early breast cancer (EBC) at risk of recurrence. Kisqali has already been approved in 99 countries worldwide, including by the FDA and the European Commission, for treatment. of […]