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Ovarian cancer clinical results and regulatory update
Relacorilant (Lifyorli) added to nab-paclitaxel (Abraxane) produced a statistically significant overall survival improvement in the phase 3 ROSELLA trial for platinum-resistant ovarian cancer,...
Regulatory setback for melanoma immunotherapy
Replimune Group received a second complete response letter (CRL) from the U.S. FDA for its immunotherapy vusolimogene oderparepvec in advanced melanoma, with the decision tied to an April 10 PDUFA...
Cell therapy funding to target GPC3 in liver cancer
Oricell Therapeutics secured $110 million to expand its cell therapy platform aimed at GPC3-positive liver cancers, where there are currently no FDA-approved therapies. The company positions its...
CAR T engineering to address escape and rejection
Researchers reported a new allogeneic CAR T-cell design that uses an anti-rejection CD70 CAR to help manage alloimmune rejection while also targeting CD19, aiming to reduce both antigen escape and...
FDA and patent-driven earnings pressure at Novartis
Novartis flagged a first annual profit drop in years for 2026 as key patents expire on blockbuster therapies including Entresto and Xolair, warning that generic competition could drive roughly $4...
CAR T design optimization for efficacy-safety balance
A study presented a CAR T-cell optimization approach that modulates receptor affinity to balance anti-tumor efficacy with safety risk. The work focuses on receptor-ligand binding characteristics...
AI automation in biotech experimentation governance
A report raises urgent governance concerns around AI systems that can design and run thousands of biological experiments with minimal human involvement, arguing that oversight mechanisms are...
Biotech laboratory infrastructure expansion: cryo-EM in antibody discovery
FairJourney Bio opened a cryo-electron microscopy (cryo-EM) structural biology facility in San Diego to embed atomic-resolution structure determination into its antibody discovery platform. The...
Clinical trial launch for prosthetic joint infection
The University of Cincinnati started a clinical trial for investigational treatments targeting prosthetic joint infections (PJI), with initial patient enrollments reported. The study is led by...
Immunology and oncology discovery: don’t-eat-me signal in AML
A cross-institution team led by Mass General Brigham, Dana-Farber Cancer Institute, and the Broad Institute identified a novel immune evasion mechanism in acute myeloid leukemia involving the...
New oncology trial results and guideline inclusion
Relacorilant (Lifyorli) plus nab-paclitaxel has posted final overall survival results in ROSELLA, a phase 3 study in platinum-resistant ovarian cancer, delivering a statistically significant...
FDA rejections for oncolytic virus melanoma therapy
FDA has again refused to move forward with Replimune’s oncolytic virus therapy for advanced melanoma, according to reports tied to another complete response letter. The agency said the company...
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...