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J&J’s oral IL‑23 pill Icotyde wins FDA nod – a straight shot at injectables
Johnson & Johnson and partner Protagonist secured FDA approval for Icotyde (icotrokinra), an oral IL‑23 receptor antagonist for moderate‑to‑severe plaque psoriasis in adults and adolescents....
In vivo CAR‑T advances: programmable engineering inside the patient
Multiple teams published methods to create therapeutic CAR‑T cells directly in vivo, demonstrating programmable, site‑specific DNA integration and durable antitumor activity in preclinical models....
Trillion Gene Atlas launched: ambitious data bet to power AI drug design
Basecamp Research announced the Trillion Gene Atlas, a partnership with Anthropic, Ultima Genomics and PacBio to massively expand evolutionary sequence diversity for AI‑driven therapeutic design....
PROTAC reaches the brain: Arvinas posts CSF LRRK2 degradation in PD
Arvinas presented Phase 1 multiple‑dose data for ARV‑102, a PROTAC targeting LRRK2, showing approximately 50% or greater reduction of LRRK2 in cerebrospinal fluid by day 14 and sustained...
Nautilus’ Voyager lands Baylor trial slot for isoform‑level tumor proteomics
Nautilus Biotechnology added Baylor College of Medicine as the first participant in its Iterative Mapping Early Access Program, providing access to the Voyager single‑molecule proteomics platform...
Cell‑free manufacturing validated at pilot scale: eXoZymes passes external run
eXoZymes’ cell‑free biomanufacturing platform was run at pilot scale by Cayman Chemical, which reported results consistent with or exceeding prior in‑house runs: a 100‑L pilot produced more than...
Congress restores SBIR/STTR seed funding – early‑stage biotech lifeline renewed
Lawmakers passed a five‑year reauthorization of the SBIR and STTR programs after a months‑long lapse, restoring a critical federal seed‑funding channel for small biotech firms. BIO and industry...
FDA signals regulatory flexibility: fewer animal studies and RMAT for on‑hold programs
The FDA unveiled draft guidance encouraging the validation of new approach methodologies (NAMs) that can reduce reliance on animal pharmacology and toxicology studies, signaling a shift toward...
Retatrutide hits endpoints — Lilly posts large weight and glucose declines
Eli Lilly reported late‑stage clinical data showing its triple‑agonist retatrutide produced substantial weight loss and clinically meaningful HbA1c reductions in patients with type 2 diabetes. The...
Pfizer seeks earlier Talzenna use after Phase 3 win
Pfizer announced Phase 3 results showing its PARP inhibitor Talzenna (talazoparib) combined with standard therapy met primary endpoints in prostate cancer, and the company said it will seek...
FDA clears Icotyde: J&J lands oral IL‑23 pill for psoriasis
Johnson & Johnson and partner Protagonist won FDA approval for icotrokinra (branded Icotyde), the first oral IL‑23 receptor antagonist cleared for moderate‑to‑severe plaque psoriasis in adults and...
In vivo CAR‑T: Dual‑vector system inserts large payloads and clears tumors
Researchers at UC San Francisco and collaborators reported a dual‑vector approach that enables precise, site‑specific integration of large DNA payloads into T cells directly in vivo, producing...
AstraZeneca bets on China — builds cell‑therapy R&D and manufacturing hub
AstraZeneca unveiled plans to invest in end‑to‑end cell‑therapy capabilities in Shanghai, including a manufacturing and supply base plus an innovation center for early research, clinical...
FDA fast‑tracks pelareorep combo for KRAS‑mutant colorectal cancer
The U.S. Food and Drug Administration granted fast‑track designation to pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI for second‑line treatment of KRAS‑mutant,...
Trillion Gene Atlas: partners pledge massive evolutionary dataset for AI drug design
Basecamp Research, together with Anthropic, Ultima Genomics and PacBio, launched the Trillion Gene Atlas initiative to vastly expand evolutionary sequence data used to train biological AI models....
Excalipoint nets $68.7M seed — backs T‑cell engagers for solid tumors
Shanghai‑based Excalipoint closed an oversubscribed $68.7 million seed financing to advance multiple T‑cell engager platforms targeting solid tumors, a headline funding round in China’s biotech...
Engineered E. coli sustains intratumoral NO — reshapes tumor microenvironment
Teams publishing in Nature Biotechnology reported engineered Escherichia coli Nissle 1917 strains carrying synthetic circuits that sustain intratumoral nitric oxide (NO) production. In mouse...
FDA pivots on preclinical rules — draft guidance and RMAT clarifications issued
The U.S. Food and Drug Administration released two policy moves that could reshape early‑stage development and regenerative medicine pathways: draft guidance encouraging reduced reliance on animal...
Lilly’s triple‑G delivers strong glycemic, weight wins – mixed reads vs Mounjaro
Eli Lilly reported Phase 3 results showing its investigational triple‑agonist retatrutide produced up to a 1.9 percentage‑point HbA1c drop and double‑digit weight loss in people with type 2...
J&J’s oral IL‑23 pill Icotyde wins FDA — rivals injectable blockbusters
The U.S. Food and Drug Administration approved icotrokinra (Icotyde), an oral IL‑23 receptor antagonist developed by Protagonist and Johnson & Johnson, for moderate‑to‑severe plaque psoriasis in...