Get the Daily Brief
Latest Biotech News
FDA-user fee and agency capacity / policy direction
The next cycle of FDA prescription drug user fee negotiations is moving through the White House review process, according to sources. The deal sets user fee levels for the agency from 2028 through...
ASCO guidance and evidence standards for cancer screening tests
ASCO said it will not recommend Grail’s Galleri MCED test for use in cancer screening after reviewing results from the NHS-Galleri randomized trial. The trial did not meet its primary endpoint of...
Phase 3 oncology readouts and major survival endpoints
Bristol Myers Squibb reported Phase 3 success for mezigdomide as an add-on to standard relapsed or refractory multiple myeloma therapy. In the Successor-2 study, the mezigdomide plus carfilzomib...
Pancreatic cancer early access and unprecedented Phase 3 survival claims
Revolution Medicines began shipping daraxonrasib to physicians and patients under an FDA-authorized early access program for pancreatic cancer, CEO Mark Goldsmith said. The drug is still...
Antibody engineering and dual targeting in immuno-oncology
Giredestrant showed consistent invasive disease-free survival benefits across menopausal subgroups in ER+/HER2− early breast cancer, according to results from the lidERA trial presented at ASCO....
Immunotherapy and next attempts at FDA approval after setbacks
Replimune is lining up a new U.S. Food and Drug Administration resubmission for its advanced melanoma drug RP-1 after reaching alignment with the agency, following two prior rejections. The...
Direct patient- and provider-facing diagnostics and testing integration
Cepheid’s point-of-care molecular vaginitis assay improved diagnostic accuracy in a randomized clinical study, driving more appropriate treatment at the first visit. In work from the University of...
Evidence generation on biomarkers in oncology trial cohorts
In a SWOG prospective cohort, microRNA 371a-3p (miR371) predicted relapse risk in early-stage testicular cancer, but experts flagged uncertainty about clinical utility. Interim results from the...
Regulatory affairs – FDA user fees and review operations
The White House is reviewing the next FDA user-fee agreement covering 2028 through 2032, according to sources. The prospective deal would determine how much the biopharma industry pays the agency...
Oncology – Combination trial wins expand multiple myeloma options
Bristol Myers Squibb reported Phase 3 results showing its CELMoD mezigdomide, added to carfilzomib plus dexamethasone, cut the risk of progression or death by 52% in relapsed or refractory...
Oncology – Early-access authorization for investigational pancreatic cancer therapy
Revolution Medicines began shipping its investigational pancreatic cancer drug daraxonrasib under an FDA-authorized early access program, CEO Mark Goldsmith said. The therapy is not yet approved,...
Oncology – Mega-deal expands China-built antibody-drug conjugates and multispecifics
Pfizer struck a broad multi-drug R&D collaboration with Innovent Biologics covering up to 12 oncology programs, including antibody-drug conjugates and multispecific antibodies. Pfizer will take...
Immuno-oncology – ASCO weighs evidence for multi-cancer early detection testing
ASCO will not recommend Grail’s Galleri multi-cancer early detection test for inclusion in cancer screening guidelines after reviewing data from a large, prospective randomized trial. The...
Gene therapy – Replimune pushes FDA resubmission for advanced melanoma
Replimune said it reached alignment with the U.S. FDA to resubmit its BLA for RP-1 (vusolimogene oderparepvec) in advanced melanoma after two prior rejections. The company characterized FDA...
Diagnostics – FDA clears tumor-only indication for Tempus xT CDx sequencing
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, expanding how clinicians can use the 648-gene tissue assay. Previously, the test...
Biomanufacturing and platforms – Portable, freeze-dried reagents expand access to biomanufacturing tools
Researchers from the University of Toronto’s Leslie Dan Faculty of Pharmacy demonstrated freeze-dried reagent and hand-powered hardware workflows designed to bring biomanufacturing and diagnostics...
Virology and maternal-fetal medicine – Dual host-targeting therapy blocks pregnancy complications
Researchers described a host-directed dual therapy intended to prevent virus-induced pregnancy complications by targeting cyclophilin A and suppressing the pathogenic interferon response. The...
Protein intelligence and discovery – ESM Atlas expands predicted protein structures beyond AlphaFold scales
The Chan Zuckerberg Initiative’s Biohub released the ESM Atlas, an open (or openly available) resource comprising more than one billion predicted protein structures and billions of sequences...
FDA regulatory framework shift and user-fee negotiations
A new report says the White House is reviewing the next FDA prescription drug user fee deal covering 2028–2032, setting up a key policy lever for how much authority the agency and industry will...
Big pharma–China partnerships in oncology
Pfizer struck a broad oncology collaboration with Innovent Biologics, committing $650 million upfront and up to $9.85 billion in milestones to co-develop a portfolio spanning 12 early-stage and de...