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Commercial deals and pipeline exits: Fulcrum Therapeutics cuts sickle cell program
Fulcrum Therapeutics said it discontinued development of its sickle cell disease candidate, pociredir, after FDA concerns about the benefit-risk profile, and moved to a strategic review. The...
Biosciences tools: integrated workflow for bispecific charge and size variant characterization
Bio-Techne and Refeyn launched an integrated characterization workflow aimed at accelerating development of bispecific antibodies and biosimilars. The approach pairs Bio-Techne’s MauriceFlex...
ADCs: Ona Therapeutics expands clinical pipeline with $86.6M Series B
Ona Therapeutics raised an oversubscribed $86.6 million Series B to push two antibody-drug conjugate candidates into human testing. The Barcelona-based biotech said the round will primarily...
Diagnostics and regulatory submissions: Tampon-based endometrial cancer methylation test validated by Abbott
Abbott validated a tampon-based endometrial cancer test developed with Mayo Clinic collaboration, aiming to provide an easier alternative to traditional in-office sampling. The PCR-based assay...
Imaging and translational oncology: methylation ctDNA to track metastatic breast cancer therapy response
Researchers unveiled methylation-based circulating tumor DNA (ctDNA) monitoring designed to track metastatic breast cancer disease progression and therapeutic response during treatment with CDK4/6...
Regulatory dispute with generics impact: Supreme Court backs Hikma in Vascepa “skinny label” patent case
The U.S. Supreme Court unanimously ruled for Hikma Pharmaceuticals in its “skinny label” patent case involving a generic version of Amarin’s Vascepa. The Court said Hikma’s generic did not...
Company expansion and community access: Cencora to distribute Kite’s CAR T-cell therapies
Cencora agreed with Kite, a Gilead company, to distribute Kite’s FDA-approved CAR T-cell therapies Yescarta and Tecartus across the U.S. The partnership is intended to expand patient access at...
Kidney disease therapeutics: finerenone shows benefit in Phase 3 FIND-CKD in non-diabetic CKD
Finerenone showed kidney-protective effects and reduced cardiovascular risk in adults with non-diabetic chronic kidney disease in the Phase III FIND-CKD trial. The results were framed as part of...
AI in clinical development operations: Medable launches agentic AI onboarding program
Medable launched its Agentic Accelerator Program to help life sciences sponsors deploy agentic AI across clinical development workflows. The program includes onboarding, integration support,...
Regulatory and legal—generics, exclusivity, and accelerated review fights
The U.S. Supreme Court unanimously ruled that Hikma’s “skinny label” generic version of Amarin’s Vascepa does not infringe Amarin’s patents, reversing a lower-court decision. The ruling preserves...
Antitrust and pay-for-delay exposure reshaping financial statements
Takeda booked a $2.5 billion provision tied to an antitrust pay-for-delay verdict after a Boston federal jury found the company liable in a class-action dispute involving Amitiza. The jury found...
Ebola diagnostics and outbreak response scale-up
The World Health Organization unveiled a six-month plan to contain the ongoing Bundibugyo Ebola outbreak, including scaling up point-of-care molecular diagnostics. WHO said the program will expand...
Biotech restructuring driven by FDA safety risk calls
Fulcrum Therapeutics disclosed a major reorganization after discontinuing development of its sickle cell disease program, pociredir. Following FDA concerns raised in a meeting about the...
Clinical-stage and platform investment—AI agent deployment for clinical development
Medable launched its Agentic Accelerator Program to help life sciences teams deploy agentic AI across clinical development workflows. The program offers onboarding, integration support,...
Drug development dealmaking—ADC pipeline expansion funding
Ona Therapeutics raised $86.6 million in an oversubscribed Series B to advance two antibody drug conjugates into early clinical testing. The Barcelona-based biotech plans to prioritize ONA-255 in...
Diagnostics and platform partnerships—mass photometry plus charge/size analytics
Bio-Techne and Refeyn launched an integrated workflow combining MauriceFlex imaging capillary isoelectric focusing (icIEF) with Refeyn’s TwoMP mass photometry platform. The goal is to let...
Genomic medicine and trial design—Precision medicine hub via AI + clinical data
Sophia Genetics and Memorial Sloan Kettering Cancer Center agreed to establish a precision medicine hub combining Sophia’s DDM AI platform with MSK’s clinical data and expertise. Sophia said the...
Nephrology trial data reshaping mineralocorticoid pathway positioning
The Phase III FIND-CKD trial reported that finerenone slowed kidney function decline and reduced cardiovascular risk in adults with chronic kidney disease without diabetes. The company...
Protein engineering and biodevice manufacturing—AAV capsid DNA quantification method
Researchers unveiled a high-resolution analytical method for quantifying DNA content within AAV capsids, targeting a persistent viral-vector characterization bottleneck. The approach uses...
Regulatory / Supreme Court—Generics access via skinny labels
The U.S. Supreme Court handed Hikma Pharmaceuticals and the generic industry a decisive win in a “skinny label” patent dispute tied to a prescription-strength fish oil product. In a unanimous...