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Cell therapy funding and registrational push for solid tumors
Oricell Therapeutics has closed a $110 million pre-IPO funding round to expand its footprint and accelerate a GPC3-targeted autologous CAR-T program for liver cancer toward registrational trials....
Antibody-drug conjugate expansion at GSK via Hansoh collaboration
GSK is planning five phase 3 studies for a gynecologic-cancer antibody-drug conjugate it licensed from Hansoh Pharma after sharing early promising data. The update reflects how ADC developers are...
Biopharma financial outlook pressure from patent expirations
Novartis has flagged that 2026 profit will likely fall for the first time in years as patents for major drugs near expiration, including Entresto and Xolair. The company projects generic...
Hypoxic ischemic encephalopathy therapy gets incremental Series A tranche
Realta Life Sciences has raised an additional $40 million in the final tranche of its Series A financing, bringing total funding to more than $150 million for its hypoxic ischemic encephalopathy...
FDA review accepted for radiolabeled glioma imaging agent
The FDA has accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), its radiolabeled glioma imaging agent, with a Sept. 11, 2026 PDUFA date. The program targets characterization...
Regulatory and market access pressure from US healthcare contracting enforcement
The Department of Justice has sued OhioHealth and NewYork-Presbyterian Hospital over contracting tactics that allegedly limit competition and keep healthcare prices high. The cases center on...
CRISPR competition signals in thalassemia cell therapy market
A Chinese CRISPR therapy for beta thalassemia that can eliminate the need for regular blood transfusions has been positioned as evidence that US drugmakers could face faster competition. Reporting...
FDA and biopharma investment: funding and market signals in oncology
Chapter has secured a $100 million Series E round aimed at addressing Medicare “mismatches” affecting seniors, according to the latest financing coverage. The round was led by Generation...
FDA regulatory decisions and CRLs for cell therapies
The FDA rejected Replimune’s oncolytic virus therapy RP1 for melanoma for a second time, underscoring persistent regulatory concerns around the trial data. The agency said the company failed to...
Funding boosts for cell therapy and oncology development
Oricell Therapeutics raised more than $110 million in a pre-IPO round to expand its solid-tumor CAR-T program, betting that armored autologous approaches can overcome the immune suppression common...
New clinical data for acute immune platelet disorder
A phase 2 trial reported that mezagitamab, an investigational antibody, significantly increased platelet counts in patients with immune thrombocytopenia (ITP). ITP is driven by immune-mediated...
FDA acceptance for radiopharmaceutical in glioma imaging
The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled glioma imaging agent using 18F-floretyrosine (18F-FET). The agency assigned a Sept. 11, 2026 PDUFA...
BioTC+ fundraising: Series A expansion in neonatal neurocritical care
Realta Life Sciences secured an additional $40 million in the final tranche of its Series A, bringing total raised to more than $150 million for its hypoxic ischemic encephalopathy (HIE)...
Strategic licensing: Gilead takes option on Kymera degraders
Gilead Sciences exercised an option to exclusively license KT-200, an oral CDK2 molecular glue degrader program developed by Kymera Therapeutics. The move expands Gilead’s strategy in targeted...
Platform buildout: FairJourney Bio opens cryo-EM structural biology CRO site
FairJourney Bio opened a new cryo-EM structural biology facility in San Diego to expand its antibody discovery capabilities with atomic-resolution services. The site includes two ThermoFisher...
Biotech product development: scaling ADC characterization with automation
Agilent Technologies highlighted how lab automation and new instrumentation can scale antibody-drug conjugate (ADC) characterization for faster and more reproducible development. The focus is on...
Cell and gene therapy scaling: neural immunology insights for sepsis
A study in Cell Death & Discovery described how CX3CR1-dependent immune networks can shape sepsis progression. The research led by Tang et al. focuses on a chemokine receptor that helps coordinate...
Drug pipeline and policy pressure in immunization oversight
A newly published charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) expands vaccine-safety monitoring as a primary function and reshapes membership criteria after a...
CAR-T and cell therapy financing and regulatory setbacks
Oricell Therapeutics moved closer to solid-tumor CAR-T commercialization with a $110 million pre-IPO round earmarked for a GPC3-targeted autologous CAR-T in hepatocellular carcinoma. The funding...
US immunization policy and CDC vaccine-study publication delays
The acting CDC director delayed publication of a study in the agency’s Morbidity and Mortality Weekly Report (MMWR) that was expected to quantify COVID-19 vaccine effectiveness against severe...