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J&J lands oral IL‑23 approval — Icotyde positioned to take on injectables
Johnson & Johnson and Protagonist won FDA approval for Icotyde (icotrokinra), an oral IL‑23 receptor antagonist for moderate‑to‑severe plaque psoriasis in adults and adolescents 12 and older. The...
CAR‑T made inside the body: targeted gene integration clears tumors in mice
Two independent reports describe major advances in generating CAR‑T cells directly in vivo. A UCSF‑led team demonstrated programmable, site‑specific integration of large DNA payloads into...
PROTAC clears CNS hurdle — Arvinas shows LRRK2 degradation in cerebrospinal fluid
Arvinas reported Phase 1 data for ARV‑102, a PROTAC degrader targeting LRRK2, demonstrating roughly 50% or greater LRRK2 reduction in cerebrospinal fluid at multiple dose levels by day 14 and...
FDA fast‑tracks oncolytic pelareorep for KRAS‑mutant CRC — response signals cited
The FDA granted fast‑track designation to pelareorep (Reolysin) in combination with bevacizumab and FOLFIRI for second‑line treatment of KRAS‑mutant, microsatellite‑stable metastatic colorectal...
Trillion Gene Atlas unveiled — massive evolutionary dataset to fuel AI drug design
Basecamp Research launched the Trillion Gene Atlas in partnership with Anthropic, Ultima Genomics and PacBio to expand evolutionary genetic diversity for AI‑driven therapeutic discovery. The...
Regulators shift away from animal studies — FDA drafts guidance, NIH marks progress
The FDA issued draft guidance outlining paths for validating New Approach Methodologies (NAMs) that can replace certain animal pharmacology and toxicology studies, signaling regulatory openness to...
Congress revives SBIR/STTR — seed funding rebooted for five years
Congress passed a five‑year reauthorization of the SBIR and STTR programs, restoring a critical federal seed‑funding mechanism for small biotech companies. The move ends a funding lapse and...
AstraZeneca builds China cell‑therapy hub — end‑to‑end manufacturing and R&D in Shanghai
AstraZeneca announced plans to create a Shanghai cell therapy research, development and manufacturing hub with capabilities spanning early R&D, clinical manufacturing and regulatory support for...
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...