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Lilly’s triple agonist hits primary endpoints – diabetes trial posts strong A1C and weight gains
Eli Lilly reported that retatrutide met primary and all key secondary endpoints in a phase III trial for type 2 diabetes, delivering significant reductions in HbA1c and substantial weight loss....
Wegovy HD cleared fast: FDA uses commissioner voucher to accelerate review
The FDA approved a high‑dose Wegovy injection (7.2 mg) for chronic weight management after an expedited review under the commissioner’s voucher program. Novo Nordisk received clearance roughly 54...
J&J’s Icotyde wins approval – oral IL‑23 pill positions to challenge injectables
Johnson & Johnson and Protagonist secured FDA approval for Icotyde (icotrokinra), an oral IL‑23 receptor antagonist for moderate‑to‑severe plaque psoriasis in adults and adolescents. The approval...
In vivo CAR‑T advances: targeted, site‑specific integration and dual‑vector systems show efficacy in animals
Two independent teams reported major advances toward making CAR‑T therapy inside the patient a clinical reality. UCSF described a dual‑vector system that achieved programmable, site‑specific...
Arvinas PROTAC achieves central target knockdown in Parkinson’s patients
Arvinas presented phase 1 multiple‑dose data for ARV‑102, a PROTAC degrader targeting LRRK2 in Parkinson’s disease, showing approximately 50% or greater reduction of LRRK2 protein in cerebrospinal...
Thymus health resurfaces as determinant of longevity and immunotherapy outcomes
Two major studies converged on the adult thymus as a clinically relevant organ beyond development. Mass General Brigham researchers used AI on 27,000 CT scans and medical records to link thymic...
Basecamp launches Trillion Gene Atlas with AI partners to scale evolutionary data for drug design
Basecamp Research announced the Trillion Gene Atlas, a large‑scale biodiversity sequencing initiative in partnership with Anthropic, Ultima Genomics, and PacBio to expand evolutionary genetic...
Oncolytics’ pelareorep granted FDA fast‑track in KRAS‑mutant metastatic colorectal cancer
The FDA granted fast‑track designation to pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI for second‑line KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer, citing...
Nautilus opens early access to Voyager proteomics platform with Baylor collaboration
Nautilus Biotechnology launched its Iterative Mapping Early Access Program and named Baylor College of Medicine its first customer for the Voyager single‑molecule proteomics platform. Baylor will...
Congress restores SBIR/STTR funding — reauthorization clears crucial early‑stage support
Congress passed a five‑year reauthorization of the SBIR and STTR programs, restoring seed funding critical to small biotech innovation. The legislation passed the House after unanimous Senate...
Lilly’s triple‑agonist slashes A1C and body weight – phase III wins
Eli Lilly reported top-line results from Transcend‑T2D‑1 showing retatrutide, a GIP/GLP‑1/glucagon triple agonist, produced up to a 2.0 percentage‑point A1C reduction and mean weight loss of 36.6...
FDA clears high‑dose Wegovy under voucher – Novo speeds comeback
The FDA granted approval for a 7.2 mg high‑dose formulation of Novo Nordisk’s Wegovy (semaglutide) after an accelerated review enabled by a commissioner’s voucher, clearing the file roughly 54...
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...