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Latest Biotech News

MS prospects revive for Novartis’ brain-penetrant BTK inhibitor

September 01, 2026

Novartis reported two Phase 3 wins for remibrutinib (Rhapsido) in multiple sclerosis, describing “superiority” versus Aubagio on annualized relapse rates and inflammatory brain lesion measures...

Lupus setback deepens for TYK2 blockers at Alumis

September 01, 2026

Alumis said its TYK2 inhibitor failed to meet efficacy goals in a mid-stage lupus study, adding to a growing set of setbacks for TYK2 blockers in autoimmune indications outside psoriasis and...

Eli Lilly expands immunology with Merida acquisition

September 01, 2026

Eli Lilly announced it will acquire Merida Biosciences in a deal valued at up to about $2.88 billion, adding a precision immunology platform focused on eliminating pathogenic autoantibodies while...

Roche deepens antibody pipeline via Simcere trispecific pact

September 01, 2026

Roche signed a deal with Simcere Zaiming for a preclinical trispecific T-cell engager antibody targeting B-cell-mediated diseases, with a $75 million upfront payment disclosed in reporting. The...

CAR-T safety prompts trial pauses at Novartis and Bristol Myers

September 01, 2026

Novartis and Bristol Myers Squibb paused parts of their autoimmune CAR-T development programs after safety concerns, with reporting citing immune-related adverse events as the trigger. The actions...

Clinical validation in acute stroke: Micot TrkB agonist hits Phase 2 endpoints

September 01, 2026

Shaanxi Micot Pharmaceutical said its injectable neuroprotective agent MT-200605 met Phase 2 endpoints in acute ischemic stroke. The program centers on a small-molecule TrkB agonist designed to...

Newco buildout for oral therapies in type 2 inflammatory diseases

September 01, 2026

Haisco expanded its newco strategy via a Sentivera transaction worth more than $1.5 billion, according to reporting. The deal created Sentivera around an undisclosed preclinical immunology asset,...

Oral mRNA flu pivot: GSK moves to Phase 3 after higher Phase 2 immune responses

September 01, 2026

GSK said it will begin a Phase 3 test of its mRNA seasonal flu vaccine candidate after a Phase 2 study showed higher immune responses than traditional flu shots. The move reflects continued...

Diagnostics commercialization: Guardant Shield colorectal screening covered by Carelon

September 01, 2026

Guardant Health said national medical benefit manager Carelon will cover its Guardant Shield blood-based test for colorectal cancer screening, effective Nov. 15. The policy update is expected to...

Commercial coverage expansion for colorectal screening

September 01, 2026

Guardant Health said Carelon Healthcare Services will cover its Shield blood test for colorectal cancer screening starting Nov. 15, expanding access through Carelon’s medical benefit management...

Autoimmunity pipeline setback in TYK2 lupus program

September 01, 2026

Alumis reported that its TYK2 inhibitor failed to meet efficacy goals in a mid-stage lupus trial, dealing a setback to its lead development program. A separate report of the same event says the...

NHS adoption of epigenetic tumor classification

September 01, 2026

Heidelberg Epignostix announced a strategic partnership with the UK NHS Genomic Medicine Service to bring its epigenetic tumor classifiers into routine NHS genomic laboratory workflows. Under the...

AI-enabled rare disease initiatives funded by ARPA-H

September 01, 2026

ARPA-H awarded up to $98.5 million for AI-enabled rare disease diagnosis, discovery, and treatment efforts, funding teams building capabilities around artificial intelligence and large multimodal...

Lilly-Merida acquisition to target pathogenic autoantibodies

September 01, 2026

Eli Lilly said it is buying Merida Biosciences to add a precision immunology platform aimed at selectively eliminating pathogenic autoantibodies while preserving broader immune function. The...

Canada regulatory approval for Fujirebio neurological blood biomarkers

September 01, 2026

Fujirebio said Health Canada has approved two of its blood-based neurological health diagnostics for clinical use, both cleared to run on the company’s automated Lumipulse G platform. The agency...

CAR-T safety pauses in autoimmune programs

September 01, 2026

Novartis and Bristol Myers Squibb halted multiple autoimmune CAR-T trials after safety concerns tied to immune-related adverse events, according to reports. In Novartis’ case, three patients died...

Takeda FDA approval for Protagonist rare blood cancer therapy

September 01, 2026

The FDA approved Takeda’s Mimrylo (rusfertide) for polycythemia vera, giving Protagonist Therapeutics a second approval and adding a potentially large revenue opportunity for Takeda as it seeks to...

Widespread execution issues in clinical trials flagged by Tufts study

September 01, 2026

A Tufts Center for the Study of Drug Development analysis found sponsors and CROs identify clinical trial risks but struggle to implement coordinated corrective action, highlighting an “execution...

Laboratory and diagnostic devices: next-generation CRISPR for at-home nucleic acid testing

September 01, 2026

A research team from The Hong Kong University of Science and Technology (HKUST) unveiled TEMPO, a one-pot CRISPR-based platform designed to deliver laboratory-like nucleic-acid testing sensitivity...

CAR-T safety pauses

September 01, 2026

Novartis halted its CD19-directed CAR-T trials after three patient deaths tied to a dangerous immune system response, according to the report. Bristol Myers Squibb also paused its autoimmune CAR-T...