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Frontline lymphoma win for Epkinly in first-line DLBCL
AbbVie and Genmab reported Phase 3 results showing their T-cell engager Epkinly (epcoritamab) plus standard chemotherapy cut the risk of disease progression or death by nearly half versus chemo...
FDA grants frontline CLL label expansion for Jaypirca (pirtobrutinib)
The FDA approved pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without del(17p), based on the Phase 3 BRUIN CLL-313...
Vaxcyte’s VAX-31 clears Phase 3 endpoints in pneumococcal vaccine
Vaxcyte said its Phase 3 pneumococcal conjugate vaccine VAX-31 met key co-primary immunogenicity endpoints in adults, sending the company’s shares sharply higher. The result sets up a potential...
GE HealthCare to buy Sofie Biosciences to expand US PET radiopharmaceutical manufacturing
GE HealthCare agreed to acquire Sofie Biosciences for $945 million in cash, aiming to expand its US footprint in radiopharmaceutical manufacturing and distribution for PET tracers. The deal is...
Caribou pauses development and reviews strategic alternatives for CAR-T programs
Caribou Biosciences said it is evaluating strategic alternatives and plans to discontinue development of its two donor-derived CAR-T programs, citing difficulty securing capital despite FDA...
ArriVent’s furmonertinib fails Phase 3 in EGFR exon 20 insertion lung cancer
ArriVent BioPharma reported that furmonertinib, its EGFR exon 20 insertion inhibitor, missed the primary objective in a Phase 3 study and the stock fell more than 50% in pre-market trading. The...
Large-scale fundraisings: Forbion lands €2.3B for two new VC funds
Forbion raised €2.3 billion across two new venture funds, the firm said, positioning the capital for investment in roughly 30 companies across its portfolios. The fundraising arrives as European...
Clinical trials infrastructure: HHS launches SURPASS to speed seamless trials
HHS launched the Simulation-augmented, real-time platform for adapted seamless trials (SURPASS) program, aimed at accelerating trial design and operations by combining digital twins, shared...
FDA regulatory process: expedited IND pilot program 'Operation TrialBlazer'
The FDA rolled out an expedited Investigational New Drug (IND) pilot program to address bottlenecks in getting drugs to first-in-human clinical testing. Named Operation TrialBlazer, the pilot is...
Softer regulatory oversight signals: 'back to basics' SEC enforcement shift
The SEC is shifting emphasis toward core enforcement priorities after Paul Atkins took over as chair in early 2025, with David Woodcock leading a new enforcement task force focused on financial...
FDA approval expands targeted therapy options in frontline CLL
The FDA approved Eli Lilly’s pirtobrutinib (Jaypirca) for adults with previously untreated CLL or SLL without del(17p), based on the Phase 3 BRUIN CLL-313 trial. The agency’s decision makes...
Vaxcyte’s pneumococcal Phase 3 readout sets up a new late-cycle market showdown
Vaxcyte said its pneumococcal conjugate vaccine VAX-31 met primary endpoints in a Phase 3 trial in adults 50 and older, driving a sharp jump in shares. The company positions the 31-valent product...
AbbVie and Genmab extend bispecific success into newly diagnosed DLBCL
AbbVie and Genmab reported a Phase 3 win for Epkinly (Genmab’s bispecific antibody) in newly diagnosed diffuse large B-cell lymphoma. The combination with R-CHOP cut the risk of disease...
Shionogi doubles down on rare diseases with $2B IntraBio acquisition
Shionogi agreed to acquire IntraBio, paying $2 billion upfront for a marketed therapy used to treat rare neurological symptoms in two disorders. The deal expands Shionogi’s rare disease portfolio...
Gene therapy and cell therapy durability and safety become sharper policy signals
A new analysis maps therapy-related blood cancer risk after CAR-T and stem cell transplantation, focusing on latency timing and clonal drivers. The systematic review found therapy-related myeloid...
GE HealthCare expands U.S. PET radiopharmaceutical manufacturing footprint
GE HealthCare agreed to acquire Sofie Biosciences for $945 million in cash to expand U.S. capacity in radiopharmaceutical manufacturing. The deal targets supply constraints for F-18 labeled PET...
FDA and HHS push to accelerate clinical trial start-up bottlenecks
The U.S. Department of Health and Human Services launched SURPASS, a program intended to modernize how seamless trials are designed and run by leveraging predictive computational models and shared...
Drug development risk: trial failure hits ArriVent’s exon 20 lung cancer program
ArriVent BioPharma reported that firmonertinib failed to delay tumor progression in a Phase 3 study in exon 20-mutated lung cancer, sending the company’s stock down. The setback renews pressure on...
Biotech funding and platform scale-up: Sensible Biotechnologies raises to build mRNA manufacturing engine
Sensible Biotechnologies raised $47 million, including a Series A and up to $20 million in non-dilutive funding from the Government of Slovakia and the European Union, to expand its integrated...
Cell therapy platform and delivery tech: lipid nanoparticles move CAR instructions without viral vectors
Researchers engineered an ionizable lipid nanoparticle system to deliver CAR-encoding mRNA into human T cells with reported efficiency above 90%, producing potent antitumor activity in vitro. The...