Get the Daily Brief
Latest Biotech News
Big pharma deals: Novo and Orbis bet on oral macrocycle biologics
Novo Nordisk struck a wide-ranging cardiometabolic research deal with Orbis Medicines, paying Orbis undisclosed upfront amounts that could total $1.4 billion in development and commercial...
Biopharma finance: Electra Therapeutics pulls in a hot IPO that targets inflammation
Electra Therapeutics priced and launched an upsized IPO on Nasdaq, raising $350 million to help fund development of its inflammation-focused pipeline. The listing follows a wave of...
Trial safety: Xenon pauses phase 3 depression enrollment after psychosis reports
Xenon Pharmaceuticals voluntarily paused new patient enrollment in its phase 3 depression program after reports of adverse events involving psychosis. The company said events were mostly mild or...
Regulatory oversight: FDA expands scrutiny of overseas clinical sites under resource constraints
The FDA announced plans to increase resources for overseas clinical trial facility inspections and to update risk-based criteria used to select sites for audit. The agency also flagged capacity...
Clinical safety and evidence generation: FDA postmarket studies still trailing original timelines
A federal review of FDA records and enforcement actions found that postmarket studies required as conditions of approval are frequently delayed or lag far behind enrollment plans. The example...
AI + drug development: virtual biotech using thousands of AI scientist agents
A Stanford Medicine spinoff launched a “virtual biotech” that deploys thousands of AI scientist agents to execute parts of drug discovery without traditional lab infrastructure. The effort,...
Funding and venture: Mithrl raises $20 million for an agentic biomedical world model
Mithrl raised $20 million in a Series A round led by Obvious Ventures, expanding development of its biomedical world model and agentic AI “harness” for model routing, token optimization, and...
Discovery platform dealmaking: Roche taps Dualitas for bispecific antibody screen up to $1 billion
Roche signed an agreement with Dualitas Therapeutics to use its Dualscreen Bispecific Discovery Engine, paying $36.5 million upfront and offering total consideration of up to $1 billion for...
Cell therapy manufacturing: Cellares expands CAR-T capacity with first Asia partnership
Cellares signed its first Asian development collaboration with Taiwanese company GenomeFrontier Therapeutics to evaluate automated manufacturing for GF-CART01 using Cellares’s Cell Shuttle...
FDA approval – gene therapy for Sanfilippo A
The FDA has approved Ultragenyx’s one-time gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A (MPS IIIA), making it the first FDA-approved disease-modifying treatment...
Biotech IPO surge – inflammation player Electra raises $350M
Electra Therapeutics has completed a $350 million IPO on Nasdaq, positioning the inflammation-focused company to fund commercialization and late-stage execution. The listing adds to a busy 2026...
Big pharma licensing exits – BMS scraps $100M Orum degrader program
Bristol Myers Squibb has ended development of an Orum Therapeutics degrader-antibody conjugate program after reviewing phase 1 data, according to a Thursday regulatory filing. The asset,...
AI–drug discovery partnership – Novo and Orbis sign up to $1.4B oral macrocycles deal
Novo Nordisk is deepening its push for orally available biologics with a multitarget partnership with Orbis Medicines to develop oral alternatives to injectable cardiometabolic treatments. Under...
AI biosecurity – lawmakers warn of misuse pathways as AI accelerates biology
U.S. lawmakers used a House hearing to warn that AI-driven tools are lowering barriers to biological misuse, including the ability to search, organize, and analyze dangerous biological information...
FDA trial acceleration – Expedited IND pilot under Operation Trialblazer
The FDA launched an “Expedited Investigational New Drug Pilot” to speed up early U.S. clinical trials and reduce timelines from discovery to first-in-human studies. The initiative, part of...
Orbis and Roche – $1B-style screening drive for immunology bispecifics
Roche has signed up Dualitas Therapeutics’ Dualscreen Bispecific Discovery Engine in a deal structured around screening more than 300,000 bispecific combinations for potential synergy in...
Ultragenyx and others in gene therapy pipeline – momentum after Sanfilippo
A cluster of approvals and related coverage highlighted a continued push in gene therapy execution and regulatory readiness, centered on Ultragenyx’s recent Sanfilippo A approval. The FDA’s...
AI-driven oral biologics – Novo signs Anthropic collaboration to accelerate R&D
Novo Nordisk entered a collaboration with Anthropic to test Anthropic’s Claude Science across Novo’s R&D workflows, aiming to speed development and strengthen software engineering. Novo said it...
Cell therapy scale-up – Cellares and GenomeFrontier automate GF-CART01 manufacturing
Cellares and GenomeFrontier Therapeutics teamed up to evaluate automated manufacturing for GenomeFrontier’s virus-free CAR T-cell therapy candidate GF-CART01 using Cellares’ Cell Shuttle platform....
AI-driven oral cardiometabolic drug discovery
Novo Nordisk is deepening its push for oral alternatives to injectable cardiometabolic biologics through a major collaboration with Orbis Medicines. The Danish companies will use Orbis’ AI-enabled...