Latest Biotech News

ARPA-H awarded up to $125 million under its GIVE (Genetic Medicines and Individualized Manufacturing for Everyone) program to build a domestic, automated network for producing on-demand RNA-based...

GSK said it will begin a pivotal Phase 3 trial for its mRNA seasonal influenza vaccine after a Phase 2 study showed higher immune responses than traditional flu vaccines. The move positions the...

Novartis halted several CAR-T trials in autoimmune diseases after observing immune-related adverse events, and Bristol Myers Squibb also paused its zola-cel program for safety review. The actions...

Genentech reported new Phase 3 results for fenebrutinib in relapsing multiple sclerosis, claiming the FENhance 1 and 2 studies met their primary endpoints. The BTK inhibitor reduced annualized...

Alumis said its TYK2 inhibitor envudeucitinib failed to improve response rates in a Phase 2b systemic lupus erythematosus (LUS) trial, dashing expectations for overall patient efficacy. The...

Ideaya Biosciences received FDA alignment on a Phase 3 study for IDE-849, a DLL3-targeted antibody-drug conjugate in extensive-stage small-cell lung cancer (ES-SCLC). The U.S. FDA type C meeting...

Roche’s Genentech unit entered a collaboration and license deal with Dualitybio worth $45 million upfront, with potential total consideration exceeding $1 billion based on development outcomes....

The U.S. Federal Circuit affirmed the validity of three patents protecting Exelixis’ Cabometyx (cabozantinib), securing exclusivity that the company expects to block generic competition for at...

Nine additional drugmakers joined the White House’s most-favored-nation (MFN) pricing initiative for Medicaid, bringing participating companies to 26 and covering 89% of the branded drug market....

Researchers at St. Jude Children’s Research Hospital, the University of Pavia, Dana-Farber Cancer Institute and Harvard Medical School unveiled AdaptiveFlow, an open-source, AI-informed platform...

ARPA-H launched the Genetics Medicines and Individualized Manufacturing for Everyone (GIVE) program, committing up to $125 million to build a domestic network for automated, on-demand RNA drug...

Novartis and Bristol Myers Squibb paused portions of their autoimmune CAR-T development after immune-related adverse events, according to separate reports. The pauses highlight continued safety...

Novartis said its BTK inhibitor remibrutinib (Rhapsido) showed “superiority” in two Phase 3 multiple sclerosis studies, reporting reduced annualized relapse rates and inflammatory brain lesions...

Genentech and Dualitybio entered a collaboration and license agreement centered on the DUPAC platform for next-generation antibody-drug conjugates. The deal supports development of new ADC...

The White House announced nine additional most-favored-nation (MFN) prescription pricing agreements with midsized and large biopharma companies, expanding coverage to Medicaid and reducing prices...

Liquid biopsy startup Senticell closed an oversubscribed seed round approaching $7 million to advance an RBC-bound nucleic acid platform licensed exclusively from the University of Pennsylvania....

Eli Lilly agreed to acquire Merida Biosciences for up to $2.875 billion, aiming to broaden its pipeline beyond obesity. Merida’s approach centers on selectively targeting pathogenic autoantibodies...

Guardant Health said Carelon Healthcare Services will cover its Shield blood test for colorectal cancer screening starting Nov. 15, enabling fully covered lives for an estimated 90 million...

Alumis reported that its TYK2 inhibitor envudeucitinib failed to meet efficacy goals in a Phase 2b systemic lupus erythematosus (Lumus) study, showing no overall response-rate improvement in the...

The White House expanded its most-favored-nation (MFN) Medicaid pricing framework, adding nine midsized drugmakers to agreements that aim to align Medicaid pricing with those in peer countries....