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Obesity drug execution risk and late-stage readouts
Eli Lilly’s obesity franchise jumped a tier higher after Phase 3 data for retatrutide reinforced the drug’s outsized weight-loss profile in people with obesity and type 2 diabetes. In the...
GLP-1 side-effect scrutiny widens beyond the gut
A controlled study has added nail changes to the growing list of concerns being monitored in people taking GLP-1 receptor agonists. Researchers reported that GLP-1 therapies were linked to...
China biotech regulatory headwinds: Ebvallo faces another FDA path
Pierre Fabre and Atara Biotherapeutics moved to restart the FDA review process for Ebvallo (tabelecleucel), a cell therapy rejected twice before. The companies resubmitted a U.S. application with...
Neuroimmune oncology: CAR macrophage checkpoint target emerges
A new preclinical study highlighted TREM2 as a switch that can reprogram CAR macrophages to attack breast cancer more effectively. Researchers reported that engagement of TREM2-dependent pathways...
Microbiome signals in cancer biology and treatment adverse events
Mayo Clinic researchers reported real-world gut microbiome differences across colorectal and breast cancers in a cohort spanning multiple cancer groups and treatment experiences. In the Mayo...
Antibiotic resistance diagnostics and faster susceptibility testing
A new diagnostic approach described a mild detergent method that preserves bacteria for rapid sepsis susceptibility testing. The workflow aims to cut time to results in bloodstream infection...
Biotech dealmaking: Sanofi expands Regeneron immunology footprint
Sanofi agreed to pay $1 billion upfront to expand its antibody collaboration with Regeneron, extending the longtime immunology alliance built around Dupixent. The expansion focuses on additional...
Cell therapy and manufacturing economics: BioNTech shuts mRNA sites
BioNTech said it will close multiple manufacturing plants in Germany after failing to find buyers for the facilities. The move affects sites in Idar-Oberstein, Marburg, and Tübingen, and BioNTech...
Clinical evidence for access acceleration in oncology
Ontario’s FAST pilot showed measurable reductions in time from a positive Canada’s Drug Agency (CDA-AMC) recommendation to provincial listing for oncology medicines. BIOTECanada and Innovative...
Base editing IP dispute escalates in rare disease field
Beam Therapeutics filed suit alleging theft of base editing trade secrets by a former scientist and new Chinese rivals, with Beam claiming its proprietary technology was used to develop a...
Obesity drug partnerships and next-gen weekly oral metabolic programs
Novo Nordisk agreed to license Hengrui Pharma’s once-weekly oral dual GLP-1/GIP receptor agonist, HRS-1596, paying $300 million upfront and up to $2.6 billion in milestones for global rights...
Regulatory reset attempts for cell therapy approvals (Ebvallo)
Pierre Fabre and Atara Biotherapeutics resubmitted Ebvallo (tabelecleucel) to the FDA after two prior rejections tied to manufacturing and trial interpretability concerns for Epstein-Barr...
Inflammation and immunology deal-making from established pharma alliances
Sanofi will pay Regeneron $1 billion upfront to expand their antibody collaboration as the Dupixent patent cliff nears. The agreement extends Sanofi’s immunology alliance, aiming to add new...
FDA starts review of Roche’s MS oral drug fenebrutinib
The FDA began review of Roche’s multiple sclerosis pill, fenebrutinib, in a process that previously had not been accepted in two major forms. The agency’s decision signals momentum for Roche’s...
Clinical-stage AL amyloidosis: Immunixes? CAR-T durability signal
Immix Biopharma reported complete remissions in 89% of patients in a clinical update for its CAR-T therapy in AL amyloidosis, a rare autoimmune disorder where misfolded proteins accumulate in...
Obesity drug clinical progress and next-wave amylin analogs
Lilly shared detailed new weight-loss data for its amylin-incretin combination eloraTZP, reporting up to 23.3% mean weight loss in adults with obesity and type 2 diabetes in updated conference...
Gene therapy durability questions in Huntington’s disease
UniQure said its Huntington’s gene therapy AMT-130 continued to slow disease progression four years after implantation, but with waning benefit magnitude versus earlier analyses. The update...
Pharma big deals and regulatory uncertainty: Summit Therapeutics oncology investment
AstraZeneca made a $2 billion investment in Summit Therapeutics, taking an equity stake and launching clinical collaboration plans around ivonescimab, an investigational PD-1/VEGF bispecific. The...
CAR-T manufacturing bottlenecks and predictive control frameworks
CAR-T is increasingly clinically validated, but manufacturing remains a scaling limiter, with donor variability, patient-specific production and complex GMP workflows restricting throughput. A new...
Antibody developability data collaboration to speed biotherapeutic translation
Ginkgo Datapoints and Apheris announced the founding members of an Antibody Developability Consortium designed to predict antibody manufacturability and developability risks earlier in...