Latest Biotech News

Novartis disclosed that three deaths in CAR-T clinical trials have prompted the company to pause rap-cel development across multiple indications, while Bristol Myers has voluntarily halted...

FDA leaders signaled enhanced scrutiny of clinical trial data generated outside the United States, aiming to ensure foreign research packages meet evidentiary expectations for U.S. regulatory...

The EMA moved to withdraw Amgen’s Tavneos (avacopan) from the market, and the U.K.’s MHRA is now joining the action. MHRA said it has removed Tavneos from use by new patients as of Sept. 1, while...

A new safety-related pause in autoimmune CAR-T research is intensifying debate over acceptable immune-system risk. According to the report, analysts believe a more cautious approach to...

Eli Lilly agreed to acquire Merida Biosciences for up to about $2.875 billion, extending Lilly’s shift toward precision immunology that targets pathogenic autoantibodies rather than broadly...

Roche secured exclusive global rights to Simcere Zaiming’s SIM-0660, a preclinical trispecific T-cell engager targeting CD79a/CD19/CD3, in a potential $1.53 billion licensing deal. Roche will pay...

An FDA biologics office official overruled a review team’s rejection and granted accelerated approval for Replimune’s melanoma treatment Tudriqev (tudirquin?) under the brand process described in...

Regulatory expectations for more process control data in continuous manufacturing are helping drive adoption of advanced monitoring, modeling, and digital control approaches. A study by Korean...

ARPA-H awarded up to $125 million to build an automated, domestic network for manufacturing individualized, on-demand RNA-based genetic medicines through its GIVE program. The funding targets...

CBER’s director of clinical evaluation, Asha Das, overruled an FDA review team to grant accelerated approval to Replimune’s melanoma therapy Tudriqev (tudriqev), according to newly described...

UniQure filed applications with the FDA and the UK’s MHRA seeking marketing approval for AMT-130, its gene therapy intended to treat the underlying cause of Huntington’s disease. The company...

The UK’s MHRA halted sales of Novartis’s Tavneos, citing regulatory action that followed the EMA’s earlier decision, according to the report. In the same update stream, UniQure’s parallel push for...

Roche struck an exclusive global licensing agreement with Simcere Zaiming for SIM-0660, a preclinical trispecific antibody designed to engage T cells while targeting B-cell markers CD79a and CD19....

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

Teva said its experimental antibody TEV ‘408 met topline results in a mid-stage gluten challenge study for celiac disease. The company reported that a single injection significantly reduced...

New mouse data published in Nature suggests semaglutide started in old age can reverse hallmarks of aging and extend lifespan. In the study, female mice treated with semaglutide in late middle age...

Novartis reported that remibrutinib, its BTK inhibitor marketed as Rhapsido for chronic spontaneous urticaria, achieved “superiority” over Aubagio in two Phase 3 trials in relapsing multiple...

Eli Lilly agreed to acquire Merida Biosciences in a deal valued at up to about $2.875 billion, extending Lilly’s push to diversify beyond obesity. Merida’s lead program, MER511, is a precision...

Fujirebio’s Lumipulse G NfL and Lumipulse G pTau 217 blood tests received Health Canada Class II medical device licenses for use in Canada. The approvals cover quantitative neurofilament light...

Alumis reported a setback for its TYK2 inhibitor envudeucitinib in a Phase 2b systemic lupus erythematosus (SLE) study, failing to achieve efficacy goals in the overall Lumus trial population....