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FDA-SEC oversight alignment reshapes pharma disclosure risk
A new memorandum of understanding between the U.S. Securities and Exchange Commission and the Food and Drug Administration formalizes tighter information sharing for pharmaceutical, biotech and...
Roche and Defand Therapeutics take a molecular-glue discovery collaboration approach in China
Roche is expanding beyond licensing by partnering with Chinese startup Defand Therapeutics to discover new molecular glue medicines. The collaboration is focused on generating multiple cancer and...
Viatris to acquire Pacira in $1.65B non-opioid pain deal
Viatris announced plans to acquire Pacira Biosciences in a $1.65 billion transaction, adding commercial-stage non-opioid pain therapies to its portfolio. The move follows Viatris’ push to build...
Bristol Myers’ Zenbexus gets FDA accelerated approval; trial shows 51% progression reduction
Bristol Myers Squibb said its multiple myeloma therapy Zenbexus, recently granted FDA accelerated approval, reduced the risk of disease progression by 51% versus standard therapy in a Phase 3...
In vivo BCMA CAR-T follow-up updates safety and durability limits
EsoBiotec provided extended follow-up data for ESO-T01, an in vivo BCMA CAR-T approach in four relapsed or refractory multiple myeloma patients. In the update, dual-phase cytokine release syndrome...
Argenx hits Sjögren’s Phase 3 futility; broader pipeline signals diverge
Argenx reported an unexpected setback after its Vyvgart program failed to outperform placebo in a Phase 3 trial in Sjögren’s disease, according to the update. The company characterized the result...
HIV prevention antibody escape: VRC01 selects low-frequency mutations
Sequencing from breakthrough infections in the AMP trials showed that prophylactic antibody VRC01 can select for low-frequency HIV escape mutations in roughly a third of treated participants. Deep...
General Medicine launches to turn patient data into a unified healthcare store
General Medicine announced plans to build a one-stop healthcare store integrating AI and human support, positioned as a practical platform for how patients access services and products. The...
COVID contact tracing automation slashes labor by 99.8% at a South Korean hospital
A Bluetooth Low Energy-based real-time location system deployed at Yongin Severance Hospital cut COVID-19 contact tracing labor by 99.8%, reducing per-case time from more than 12 hours to about 10...
Vaginal-to-blood targeting: a blood-based methylation panel for esophageal cancer detection
A two-cohort study reported that a blood-based DNA methylation panel targeting HYAL2, S100P and DYRK4—combined with routine blood count parameters—can detect esophageal squamous cell carcinoma...
FDA accelerated approval reshapes multiple myeloma outcomes
Bristol Myers Squibb said Zenbexus, which received FDA accelerated approval to treat multiple myeloma, reduced the risk of disease progression by 51% versus standard therapy in a Phase 3 trial....
Viatris’ $1.65B Pacira acquisition accelerates non-opioid pain buildout
Viatris agreed to acquire Pacira BioSciences for $1.65 billion in cash, betting on a further expansion of its non-opioid pain portfolio. The deal adds commercial-stage assets in pain management at...
Roche shifts from licensing to early invention with Defand Therapeutics
Roche is deepening its China strategy by moving beyond licensing into new medicine discovery with Defand Therapeutics. Under the collaboration, Defand will discover and develop multiple...
ARPA-H funds room-temperature biostabilization for cell therapies
ARPA-H awarded up to $87 million for its BioStabilization Systems (BoSS) program, funding three teams to address cold-chain bottlenecks for cell-based biologics. The initiative aims to enable...
Caribou Biosciences winds down allogeneic CAR T programs
Caribou Biosciences will stop work on two remaining off-the-shelf allogeneic CAR T programs and pursue strategic alternatives after failing to secure enough financing for late-stage clinical...
Roche vs Halozyme patent dispute blocks subcutaneous Keytruda in Europe
A Dutch court blocked Merck from manufacturing and selling injectable Keytruda’s subcutaneous formulation in eight European countries after finding Halozyme patent infringement. The ruling adds to...
EU moves to rebuild clinical trials database for Biotech Act compliance
The European Medicines Agency said the Clinical Trials Information System (CTIS) will need a major rebuild to accommodate the proposed EU Biotech Act. The agency cited that the potential changes...
Argenx stumbles in Sjögren’s Phase 3 as Vyvgart misses placebo
Argenx reported an unusual setback in Sjögren’s disease after Vyvgart failed to outperform placebo in a Phase 3 trial, prompting a stock drop and overshadowing a concurrent celiac-disease win. The...
Antibody validation and reproducibility face renewed scrutiny
A new Primer in PLOS Biology warns that poorly validated antibodies can silently mislead biomedical research, with a large-scale test finding more than half of evaluated antibodies unfit for at...
Cold-chain breakthrough for pediatric heart transplants after circulatory death
Vanderbilt surgeons reported that a cold, oxygen-rich preservation method called REUP enabled ten pediatric heart transplants from donors after circulatory death, including hearts that would...