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Pfizer and Innovent expand multibillion-dollar antibody-drug conjugate and multispecific pipeline
Pfizer announced a wide-ranging oncology collaboration with Innovent Biologics covering 12 early-stage and de novo antibody-drug conjugate and multispecific programs. The deal includes $650...
China issues finalized drug trial data protection rules
China’s National Medical Products Administration issued final implementation measures for drug trial data protection, positioning the country closer to global norms for pharmaceutical IP. The...
GSK bepirovirsen delivers functional cure signal in Phase 3 chronic hepatitis B
GSK reported Phase 3 results for bepirovirsen, an antisense oligonucleotide in development for chronic hepatitis B, describing a functional cure rate of 19% across two trials after discontinuation...
AbbVie wins FDA approval for Decnupaz in BPDCN
AbbVie received FDA approval for Decnupaz (pivekimab sunirine), a CD123-targeting antibody-drug conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval...
Tempus gains FDA approval for tumor-only version of xT CDx
Tempus AI said the FDA approved a tumor-only indication for its xT CDx 648-gene next-generation sequencing platform, expanding flexibility when matched normal tissue is unavailable. The assay is...
Diagnostics expansion: Delfi wins New York approval for blood-based lung cancer LDT
Delfi Diagnostics said the New York State Department of Health approved its FirstLook Lung laboratory-developed test, enabling the company to offer its cfDNA-based liquid biopsy screening assay...
Biotech leadership change at Allogene signals strategy reset
Allogene Therapeutics appointed Zachary Roberts, its EVP of R&D and CMO, to succeed co-founder David Chang as president and CEO. Roberts will start July 1, while Chang will remain on the board...
Clinical genomics and diagnostics: Labcorp study tests multigene panels in colorectal cancer
Labcorp partnered with ACTO to launch a clinical trial evaluating the impact of multigene panel testing on colorectal cancer patient care and on driving testing among at-risk relatives. Labcorp...
Big pharma licensing and China R&D scale-up
Pfizer and Innovent Biologics escalated China-linked oncology dealmaking with a multi-drug collaboration spanning 12 early-stage and de novo antibody programs. Pfizer will pay Innovent $650...
Multiple myeloma: next-gen CELMoD efficacy at ASCO
Bristol Myers Squibb reported Phase 3 SUCCESSOR-2 results for mezigdomide (MeziKd), showing a 52% reduction in the risk of disease progression or death versus carfilzomib plus dexamethasone alone....
Hepatitis B: antisense ‘functional cure’ milestone clears Phase 3 readouts
GSK reported Phase 3 efficacy for bepirovirsen, an antisense oligonucleotide targeting hepatitis B virus transcripts, with a functional cure rate of about 19% across two trials after...
FDA regulation and review pathways for biotech drugs
The FDA’s next multi-year prescription drug user fee framework is under review at the White House for 2028 through 2032, according to sources. The development follows broader political scrutiny of...
FDA approvals and label expansions in oncology
AbbVie won U.S. FDA clearance for Decnupaz (pivekimab sunirine), a CD123-targeting antibody-drug conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval...
Regulatory integrity and reproducibility failures in AI clinical modeling
A pair of researchers led by Adrian Barnett (Queensland University of Technology) and Alexander Gibson have traced flawed datasets on Kaggle to clinical-model training papers and reported...
AI-enabled point-of-care diagnostics and liquid biopsy access
Tempus AI obtained FDA approval expanding its xT CDx comprehensive genomic profiling assay to a tumor-only use case when matched normal tissue is not viable. Tempus said the 648-gene tissue assay...
Clinical development resubmissions after FDA rejections
Replimune is taking a third swing at U.S. FDA approval for its advanced melanoma therapy RP-1 (vusolimogene oderparepvec) after twice receiving complete response letters. The company said it...
AI-assisted care delivery: direct-to-patient pharmacy platform build
CareTria acquired CaryHealth to combine therapy initiation services with CaryHealth’s AI-powered digital pharmacy platform. The integrated approach targets friction points from prescription...
Funding and corporate expansion: capital to scale biotech innovation
Garner Health raised $100 million in a Series E round led by Index Ventures with participation from Kleiner Perkins, Redpoint, Thrive, Sequoia, Founders Fund, and Kaiser Permanente Ventures. The...
Oncology platform licensing
Pfizer struck a wide-ranging licensing and collaboration deal with Innovent Biologics for 12 early-stage and de novo oncology programs, spanning eight Innovent discovery assets and four...
Multiple myeloma Phase 3 wins for CELMoD
Bristol Myers Squibb reported Phase 3 results for its cereblon E3 ligase modulator mezigdomide, showing a 52% reduction in the risk of disease progression or death when added to Amgen’s Kyprolis...