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Regulation & access: Medicaid pricing model expansion
President Trump announced that all 50 U.S. states, plus Washington, DC and Puerto Rico, will participate in a new Medicaid drug pricing structure designed around most-favored-nation principles....
Biopharma IPOs & capital markets: Electra’s $350M raise
Electra Therapeutics priced its upsized $350 million IPO, positioning the inflammation-focused company for a more commercial-ready footing as it advances ipsoprubart (a pan-SIRP monoclonal...
CDMO manufacturing innovation: GBI SmartScale GMP solutions
GBI Biomanufacturing is set to launch its SmartScale GMP Solutions platform at BioProcess International East, pitching an accelerated small-scale cGMP pathway to generate GMP material for...
CDMO supply resilience: Raw-material risk at BPI East
Nu-Tek BioSciences used BioProcess International East to put raw-material risk management at the center of bioprocess planning, focusing on animal-origin-free peptones and protein hydrolysates for...
Reverse M&A & new public platforms: North Immunology deal and funding
North Immunology is going public via a reverse merger with Aethlon Medical, raising $180 million to advance a long-acting, dual-acting immunology and inflammation program for atopic dermatitis....
China regulatory progress: Sino Biopharmaceutical filings
Sino Biopharmaceutical moved two internally developed assets closer to commercialization in China, with the Center for Drug Evaluation accepting NDAs for TQB-2102 and TQH-2722. The submissions...
Biotech startup finance: Mithrl’s $20M Series A for biomedical world model
Mithrl raised $20 million in a Series A led by Obvious Ventures to expand deployment of its biomedical world model across biopharma research teams. The company said it is building a...
Neuro innovation: Ariadne Bio spinout for Parkinson’s apathy
Palomar Labs spun out Ariadne Bio to develop AB-300, a non-hallucinogenic 5-HT2A receptor agonist targeting apathy in Parkinson’s disease. The venture studio said Ariadne will focus on...
Scientific research: kidney organoids reveal inflammatory drivers in diabetic kidney disease
Human kidney organoid experiments linked elevated glucose exposure to tissue-intrinsic inflammation and epithelial detachment, offering a mechanistic view of diabetic kidney disease beyond...
FDA gene therapy approvals for ultra-rare disease
The FDA approved Ultragenyx’s gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A, marking the first FDA-approved treatment specifically for this ultra-rare, fatal...
Company clinical trial risk—depression pause tied to neuropsychiatric events
Xenon Pharmaceuticals paused new enrollment in its Phase 3 depression program for azetukalner after reported neuropsychiatric adverse events, sending shares down as investors recalibrate the...
FDA oversight expansion—more scrutiny of foreign clinical trial sites
The FDA said it will increase resources for overseas bioresearch monitoring inspections and update risk-based criteria used to select foreign clinical trial sites for audit. The agency tied the...
China’s policy push for global biopharma expansion
China’s government issued a new five-year plan that sets ambitious targets for expanding the country’s role in the global biopharma market. The policy direction signals renewed pressure on...
Ultra-rare gene therapy economics—FDA approval vs pricing scrutiny
Ultragenyx’s Sanfilippo approval arrives as pricing details circulate, with the therapy priced at $4 million for Sanfilippo gene therapy treatment, underscoring how ultra-rare approvals can...
AI-driven oral peptide chemistry deal—Novo and Orbis commit up to $1.4 billion
Novo Nordisk entered a major cardiometabolic deal with Orbis Medicines to develop oral alternatives to injectable therapies using AI-enabled macrocycle design. Orbis could receive undisclosed...
Bispecific antibody discovery—Roche pays Dualitas for large screening drive
Roche signed a deal with Dualitas Therapeutics to use the company’s Dualscreen Bispecific Discovery Engine to screen more than 300,000 bispecific antibody combinations. The agreement calls for...
Biotech IPO window—Electra Therapeutics raises $350 million
Electra Therapeutics priced a $350 million Nasdaq IPO, positioning the inflammation-focused biotech to expand its commercial ambitions while continuing development in immune-mediated disease...
Biotech platform financing—Mithrl raises $20 million for biomedical world model
Mithrl raised $20 million in a Series A round led by Obvious Ventures to expand its biomedical world model and agentic AI tooling for drug discovery and development acceleration. The company,...
FDA and industry compliance—postmarket study follow-through gaps
A KFF Health News analysis highlights how FDA-ordered postmarket studies for drugs and devices frequently lag, leaving limited real-world safety answers even after regulatory approvals. The review...
Regulatory approvals: first-in-class gene therapy for ultra-rare neurodegeneration
The FDA on Thursday approved Ultragenyx’s gene therapy for Sanfilippo syndrome type A, delivering a once-intravenous AAV9 vector designed to restore SGSH enzyme activity. The therapy, branded...