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FDA scrutiny and revised clinical evidence for cell therapy approvals
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics resubmitted Ebvallo (tabelecleucel) to the FDA after two prior rejections, seeking approval for EBV+ PTLD following transplant. The companies...
Obesity pipeline escalation as Lilly’s retatrutide posts phase 3 weight-loss benchmarks
Eli Lilly’s retatrutide strengthened the next-generation obesity playbook with phase 3 data showing weight losses across doses in people with obesity and type 2 diabetes. The reports highlighted a...
Merck’s multi-billion oncology licensing bet on KRAS G12D molecular glue from China
Merck moved to secure next-generation KRAS biology through an exclusive global licensing deal for SciBrunch Therapeutics’ preclinical oral KRAS G12D (on) molecular glue candidate SPR2015. The...
AstraZeneca invests $2B in Summit’s PD-1/VEGF bispecific and sets ADC combination trials
AstraZeneca finalized a $2 billion equity investment in Summit Therapeutics, taking a stake while launching clinical collaboration plans to test Summit’s ivonescimab with AstraZeneca’s...
Novo renews obesity expansion with a weekly oral GLP-1/GIP license from Hengrui
Novo Nordisk licensed ex-China rights to Hengrui’s HRS-1596, a once-weekly oral GLP-1/GIP receptor dual agonist, in a deal valued at up to $2.6 billion including a $300 million upfront payment....
Biotech IP litigation escalates as Beam sues rival base-editing claims
Beam Therapeutics filed a lawsuit alleging that a former scientist stole confidential information and helped seed a competing therapy through a China-based startup ecosystem. The complaints name...
Huntington gene therapy durability review pressures UniQure as four-year data show waning effect
UniQure’s Huntington’s disease gene therapy AMT-130 continued to slow disease progression at the four-year follow-up, but the magnitude of benefit declined versus earlier analyses. The update...
BioNTech to close German manufacturing sites after failing to find buyers
BioNTech will close three manufacturing sites in Germany—Idar-Oberstein, Marburg, and Tübingen—after failing to secure buyers for the facilities. The company said it ended its sales process...
CAR-T manufacturing bottleneck becomes a focus for predictive control platforms
A new industry analysis reframed the CAR-T manufacturing bottleneck as a transition from reactive batch execution to predictive process control. The report argues that scalable access is...
Regulatory flexibility debate: EMA argues against rigid one-trial standards while referencing FDA
The European Medicines Agency argued that drug development should focus on generating robust evidence rather than adhering to a rigid default on the number of pivotal trials. In an editorial...
Lilly elevates obesity-and-diabetes triple-agonist momentum at EASD
Eli Lilly used EASD26 to push its next-generation obesity-and-type-2-diabetes strategy forward, highlighting new clinical results for retatrutide. Across presentations tied to the TRIUMPH-2...
Lilly’s TRIUMPH-2 results set a new weight-loss benchmark in phase 3
Eli Lilly reiterated retatrutide’s phase 3 strength for obesity with type 2 diabetes, framing TRIUMPH-2 as a major milestone for the weight-loss drug class. In the study, patients receiving the...
Merck-BIOCENTURY: $2.13B KRAS G12D molecular glue deal from SciBrunch
Merck signed a licensing and collaboration agreement for SciBrunch Therapeutics’ preclinical KRAS G12D molecular glue inhibitor SPR2015, a deal that could reach $2.13 billion. The agreement grants...
AstraZeneca loads $2B into Summit’s PD-1/VEGF bispecific for ADC combinations
AstraZeneca announced a $2 billion equity investment in Summit Therapeutics alongside plans to run clinical collaboration trials pairing Summit’s PD-1/VEGF bispecific ivonescimab with AstraZeneca...
Regulatory setback: Merck and Daiichi withdraw B7-H3 ADC BLA for extensive-stage SCLC
Merck and Daiichi Sankyo voluntarily withdrew their BLA for ifinatamab deruxtecan (i-dxd), a B7-H3-directed antibody-drug conjugate in extensive-stage small-cell lung cancer. The withdrawal...
Beam escalates IP fight over base editing tech tied to YolTech and Serapha
Beam Therapeutics filed suit alleging a former scientist stole its base editing intellectual property and helped co-found a Chinese company, YolTech, which later contributed to an AATD program...
UniQure’s Huntington gene therapy durability concerns deepen at four-year follow-up
UniQure disclosed updated four-year follow-up data for its Huntington’s gene therapy AMT-130, sparking fresh scrutiny over durability of benefit. While the company reported a continued...
FDA decision risk-free? Otsuka and Ionis report phase III win in FUS-ALS
Otsuka and Ionis Pharmaceuticals reported positive phase III results from the Fusion study of ulefnersen in FUS-associated amyotrophic lateral sclerosis (ALS). The data showed statistically...
Venture and platform buildout: Tiny Health raises $33M to expand microbiome testing
Tiny Health secured $33 million in Series B funding to expand its microbiome testing capabilities. The round was led by B Capital with participation from multiple health-focused venture...
Data infrastructure for antibodies: Ginkgo Datapoints and Apheris launch Developability Consortium
Ginkgo Datapoints and Apheris announced founding members of a new Antibody Developability Consortium aimed at predicting antibody manufacturability and developability risks earlier in discovery....