Get the Daily Brief
Latest Biotech News
Regulatory approvals – radioligand therapy expands in prostate cancer
FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), extending...
FDA decisions and advisory committee outcomes – cell therapy effectiveness questioned
Capricor’s Deramiocel faced another major setback as the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recommended against approval following its resubmitted biologics license...
Clinical trial readouts – failed IL-6 strategy in ZEUS cardiovascular Phase 3
Novo Nordisk’s IL-6 inhibitor ziltivekimab failed to reduce major cardiovascular events in the late-stage ZEUS Phase 3 program, sending shares down more than 9% in premarket trading. The trial...
Deal-making – potential merger talk sparks market reaction
Reports that AstraZeneca and Bristol Myers Squibb held merger discussions pushed AstraZeneca shares lower as investors weighed the likelihood of regulatory and business-overlap hurdles. Separate...
Leadership change – BioNTech brings in incoming CEO from Sobi
BioNTech named Guido Oelkers as its incoming CEO, continuing the company’s shift from COVID-era mRNA leadership toward oncology. Oelkers, who previously led Swedish biopharma company Sobi, will...
CNS sector – Supernus and Indivior sign all-stock merger
Supernus Pharmaceuticals and Indivior agreed to an all-stock merger to form a CNS-focused drugmaker based in Rockville, Maryland. The combined company keeps the Supernus name, aiming to...
Oncology – ODAC vote supports RP1 with nivolumab in melanoma
Repligen’s oncolytic virus therapy vusolimogene oderparepvec (RP1, marketed through Replimune) cleared a key hurdle as the FDA’s ODAC/CTGTAC panel supported an accelerated-approval pathway in...
Biomarkers and diagnostics – Roche partners with Genprex on TROP2 assay validation
Genprex and Roche Diagnostics launched collaboration work aimed at validating biomarker assays using Genprex’s TROP2 approach in non-small cell lung cancer. Genprex said it plans to potentially...
Drug distribution policy – Arkansas Act 630 blocked after court ruling
Arkansas stopped enforcing Act 630 governing drug distribution after a federal court found the measure likely unconstitutional. Following the court decision, the Arkansas State Board of Pharmacy...
Funding and public markets – BlossomHill targets an IPO to back EGFR oncology pipeline
BlossomHill Therapeutics filed plans for an IPO targeting about $111.7 million to fund the clinical path of its EGFR-targeting drug candidate BH-30643, positioned as a potential challenger to...
Regulatory setbacks in cell therapy for DMD cardiomyopathy
Capricor Therapeutics’ resubmitted biologics license application for Deramiocel took another hit after the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted against approval. In...
FDA approval expands radioligand therapy to earlier prostate-cancer stage
The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with an androgen receptor pathway inhibitor (ARPI) for PSMA-positive metastatic hormone-sensitive prostate cancer...
Late-stage failure reshapes IL-6 inhibitor bets in cardiometabolic disease
Novo Nordisk’s IL-6 inhibitor ziltivekimab failed in a cardiovascular Phase 3 trial, sending shares down more than 9%. In the ZEUS study, the drug did not reduce the risk of major adverse...
Oncology regulatory caution over accelerated approval underuse
Researchers writing in JAMA raised alarms about what they describe as underutilization of the FDA’s accelerated approval pathway in adult oncology. A cross-sectional analysis of 385 adult cancer...
Replimune oncolytic virus regains footing with ODAC-level recommendation
Replimune’s oncolytic melanoma therapy vusolimogene oderparepvec (RP1) cleared a key regulatory hurdle after the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 10–3...
First oral sleep apnea drug heads to FDA decision after $192M IPO
Apnimed raised $192 million in an IPO to fund Oxnimbi, a once-nightly oral candidate for obstructive sleep apnea. The company plans to use the proceeds to advance the regulatory process and launch...
Alzheimer’s diagnosis expands with blood-based amyloid testing
Blood-based biomarker testing is expanding access to Alzheimer’s disease assessment following FDA clearance of a new automated plasma ratio test. Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42...
Massive contamination outbreak linked to iceberg lettuce cluster
Cyclosporiasis cases surged this summer, with Michigan reporting more than 10,000 infections and 193 hospitalizations as of July 30, far above typical annual levels. Officials tied a major cluster...
AI tool benchmarks for drug discovery evaluation
Insilico Medicine launched what it calls the drug discovery benchmark-as-a-service for frontier AI models, targeting weaknesses in how AI systems are evaluated. The initiative is designed to test...
TAO of large-scale organ generation via xenophagocytosis control
Researchers at the Institute of Science Tokyo reported a strategy to block xenophagocytosis, an immune process that limits interspecies organ generation. By uncovering how embryonic macrophages...