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FDA signals tailored, long‑term oversight for CAR‑T in autoimmune diseases
Regulators at the FDA have flagged a flexible but precautionary approach to CAR‑T therapies for autoimmune diseases, urging developers to design long‑term monitoring comparable to requirements for...
Pfizer takes $4.4B hit amid pipeline pruning — strategy refocuses R&D spend
Pfizer disclosed $4.4 billion in impairment charges tied to recent portfolio adjustments and announced multiple early‑stage program discontinuations as part of a broader pipeline pruning exercise....
Protein language models reprogram CRISPR PAM specificity — new editing frontier
Two Nature Biotechnology papers describe AI‑driven protein language models and model‑guided evolution that reprogram protospacer adjacent motif (PAM) specificity of CRISPR–Cas enzymes, expanding...
Single‑shot HIV vaccine shows neutralizing responses in primates — Wistar announces breakthrough
Researchers at The Wistar Institute reported a single‑immunization HIV vaccine candidate that elicited neutralizing antibodies in nonhuman primates, a milestone published in Nature Immunology. The...
Genentech inks $1.7B RNAi pact with SanegeneBio — $200M upfront
Genentech agreed to license an undisclosed RNA interference (RNAi) program from China-based SanegeneBio in a deal that pays the biotech $200 million up front and could reach roughly $1.7 billion...
AccurEdit snaps up $75M — China CRISPR startup scales clinic push
AccurEdit Therapeutics, a Suzhou-based gene editing startup, raised $75 million in a Series A round to advance CRISPR-based programs toward the clinic. The financing ranks among the larger Chinese...
WHO backs long-term GLP-1s for obesity — first global guideline
The World Health Organization released its first-ever guidelines on pharmacotherapy for obesity, recommending that GLP-1 receptor agonists can be part of long-term management for people with...
Promega wins NMPA approval — MSI kit cleared as Keytruda companion diagnostic
Promega’s OncoMate Microsatellite Instability (MSI) Detection Kit received National Medical Products Administration (NMPA) approval in China as a Class III in vitro diagnostic and was cleared for...
Diasorin files 15‑minute molecular strep test to FDA — seeks CLIA waiver
Diasorin submitted its 15-minute point-of-care molecular Group A Streptococcus assay, Liaison Nes Group A Strep, to the U.S. Food and Drug Administration for 510(k) clearance and a CLIA waiver....
FDA opens PreCheck program — drugmakers invited to speed US factory builds
The U.S. Food and Drug Administration launched its PreCheck pilot program and began accepting submissions from pharmaceutical manufacturers seeking alignment on facilities that support national...
Ultragenyx unveils new Sanfilippo A data — aims to sway FDA on resubmission
Ultragenyx released new cognitive and safety data from its gene therapy program for Sanfilippo syndrome type A as part of a planned resubmission to the U.S. FDA. The company reported cognitive...
Insilico hits milestone after AI‑designed MEN2501 dosed in humans — $5M paid
Insilico Medicine announced the first‑in‑patient dosing of MEN2501—a small‑molecule oncology candidate discovered using generative AI—under a licensing deal with Menarini, triggering a $5 million...
MGI to buy BGI spatial and nanopore units — bets on a 'Seq All' strategy
MGI Tech filed plans to acquire STOmics and CycloneSeq—two BGI Group subsidiaries commercializing spatial (Stereo‑Seq) and nanopore sequencing technologies—for RMB 365.7 million (~$52.6 million)....
PacBio sells short‑read assets to Illumina — shifts focus to long‑read platform
Pacific Biosciences sold select short‑read sequencing intellectual property and related assets—originally acquired via Apton/Omniome—to Illumina for $48.1 million in cash, a move PacBio said...
AI designs drug — Insilico hits clinic, VCs back lab-born scientist
Insilico Medicine announced first-in-patient dosing of MEN2501, an oncology candidate discovered with generative AI, triggering a $5 million milestone payment from Menarini under their licensing...
Ultragenyx unwraps data — new readout targets FDA resubmission
Ultragenyx disclosed new clinical data from its resubmitted gene therapy for Sanfilippo syndrome type A aimed at convincing the FDA to grant approval. The company reported cognition-related...
Pfizer’s Metsera bet pays off — monthly GLP-1 posts competitive weight loss
Pfizer released Phase 2b data showing its Metsera-originated monthly GLP-1 delivered clinically meaningful weight loss and glycemic control. The company reported up to 10.5% mean body-weight...
Novo’s combo shot tops semaglutide: Phase 3 win sharpens obesity drug rivalry
Novo Nordisk reported that its combination candidate CagriSema beat semaglutide in a Phase 3 diabetes study, showing superior reductions in blood glucose and greater weight loss. The company...
Big pharma doubles down on RNAi — Genentech and Roche strike Sanegene pacts
Genentech agreed to license a SanegeneBio RNAi program for up to $1.7 billion in milestones, paying $200 million up front and taking worldwide rights to advance the candidate into clinical...
FDA pushes long-term CAR-T follow-up — in vivo CAR advances complicate safety planning
FDA officials urged sponsors to design long-term monitoring for CAR‑T programs aimed at autoimmune diseases, citing concerns such as secondary malignancy risk and fertility effects. The agency’s...