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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FDA pivots on preclinical rules — draft guidance and RMAT clarifications issued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...
In vivo CAR‑T advances: two-vector approaches show programmable, site‑specific edits
Academic teams and startups published converging proofs that CAR‑T cells can be generated and genomically integrated inside living hosts. UCSF researchers reported a dual‑vector system that...
Basecamp launches Trillion Gene Atlas — big data for AI drug design
Basecamp Research unveiled the Trillion Gene Atlas, a collaboration with Anthropic, Ultima Genomics and PacBio to generate environmental sequence data at unprecedented scale to train therapeutic...
WHO debuts near‑POC TB test class — Pluslife’s MiniDock leads push for decentralized diagnostics
The World Health Organization introduced a new class—near‑point‑of‑care nucleic acid amplification tests (nPOC‑NAATs)—designed for decentralized TB testing using swab specimens and simple...
Cell therapy scale-up: AstraZeneca invests in China; Sartorius unveils Eveo manufacturing stack
AstraZeneca announced plans to build an end‑to‑end cell therapy manufacturing and innovation hub in Shanghai to support CAR‑T and next‑generation cell therapies across Asia, complementing prior...
Precision oncology diagnostics: Myriad’s MyChoice gains FDA nod as partners co‑develop liquid and tissue tests
Myriad Genetics secured FDA approval for its MyChoice CDx as a companion diagnostic to stratify patients for GSK’s PARP inhibitor Zejula in advanced ovarian cancer, using BRCA sequencing plus a...
SBIR/STTR reauthorization returns — Congress restores seed funding for startups
Congress passed a five‑year reauthorization of the SBIR and STTR programs after a multimonth lapse, restoring critical federal seed grants for small biotech firms. BIO hailed the move as essential...
FDA shifts: RMATs for trials on clinical hold; guidance nudges reduction of animal testing
The FDA updated policies to allow regenerative medicine advanced therapy (RMAT) designations for candidates even if programs are on clinical hold, a procedural change that can preserve regulatory...
Investors back next‑gen T‑cell programs: Crossbow, Excalipoint raise major rounds
Two private financings reinforced investor appetite for engineered‑T and T‑cell engager platforms. Crossbow Therapeutics closed a $77 million Series B to advance T‑cell‑receptor‑mimetic...