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Regeneron and Parabilis deepen ADC-like collaboration for difficult targets
Regeneron entered a new $2.3 billion agreement with Parabilis Medicines to develop a new type of antibody-drug conjugate-like therapy aimed at harder-to-reach or harder-to-engage targets....
MD Anderson advances CD94-targeted CAR T under new FDA IND
MD Anderson received FDA IND clearance to start a phase I trial of JV-394, a CAR T-cell therapy targeting CD94-positive T and natural killer lymphomas. The study will enroll patients with relapsed...
Quince exits after rare-disease failure via reverse merger with Orphai
Quince Therapeutics announced it will pursue an exit strategy after a phase 3 rare disease setback, agreeing to merge with private pulmonary startup Orphai Therapeutics via a reverse merger. The...
FDA litigation setback for brand drugmakers’ Medicare price negotiation challenge
The Supreme Court declined to take up lawsuits challenging Medicare drug price negotiations, dealing another blow to the brand-drug industry’s legal strategy. The decision affects cases filed by...
BIO pushes FDA to refine its Plausible Mechanism Framework
The Biotechnology Innovation Organization (BIO) submitted comments supporting the FDA’s proposed Plausible Mechanism Framework, which is intended to help evaluate safety and efficacy for...
Regeneron’s melanoma LAG-3 combo fails to beat Keytruda in Phase 3
Regeneron’s two-drug regimen combining fianlimab and Libtayo did not significantly outperform pembrolizumab (Keytruda) in a late-stage melanoma trial, adding to pressure on LAG-3-targeted...
Regeneron-led stock volatility highlights DMD gene therapy regulatory uncertainty
Shares of Regenxbio sank sharply despite positive pivotal Phase III data for its Duchenne muscular dystrophy gene therapy candidate RGX-202. Reporting highlighted investor concerns after the...
Neonatal lung disease research links oxygen variability to bronchopulmonary dysplasia risk
New clinical research is sharpening understanding of bronchopulmonary dysplasia (BPD) risk in preterm infants by connecting hypoxic burden—periods of reduced oxygen—with later BPD development. The...
Regulatory action reshapes cell therapy development
The FDA cleared the University of Texas MD Anderson Cancer Center to start a phase I study of JV-394, a CD94-targeted CAR T-cell therapy, for patients with relapsed or refractory CD94-positive...
Late-stage oncology setbacks at Regeneron intensify LAG-3 pressure
Regeneron’s LAG-3 inhibitor fianlimab posted a phase 3 miss in melanoma, failing to outperform pembrolizumab (Keytruda) in a late-stage study. The result adds to recent clinical setbacks across...
Company strategy and dealmaking accelerates outside of pure GLP-1
Eli Lilly is reshaping its obesity dependence narrative by acquiring non-GLP-1 assets, according to details tied to its Q1 2026 business updates. The company’s deal slate since January includes...
Obesity-focused oral GLP-1 data sparks Chinese regulatory pursuit
Vincentage Pharma said its oral GLP-1 agonist was associated with mean weight loss of 12.4% over one year and is preparing to pursue Eli Lilly’s orforglipron route with Chinese regulatory...
FDA approval expands hypertension treatment options
The FDA approved AstraZeneca’s baxdrostat for certain patients with hypertension, according to the company. Baxdrostat is intended to address elevated aldosterone pathways, giving physicians...
Precision oncology and biomarker targeting move into radiotherapy workflows
At ESTRO 2026, researchers presented approaches aimed at tailoring radiotherapy using circulating tumor DNA (ctDNA) and blood-based testing. The reported work describes a new blood test designed...
Regulatory framework guidance for individualized therapies
The Biotechnology Innovation Organization (BIO) submitted comments supporting the FDA’s proposed Plausible Mechanism Framework for individualized and disease-targeted therapies where traditional...
Vaccum-up value and re-upping deals as risk capital stays selective
JPMorgan’s analysis shows biopharma dealmaking surged in Q1 2026, driven mainly by licensing and M&A even as venture capital stayed cautious toward early-stage risk. The report cited licensing...
Obesity and metabolic device-like innovation heads toward next funding steps
Durabilityte unveiled a platform aimed at disrupting biologics production using implantable “cell factories”—cells engineered to secrete therapeutic proteins from inside the body. The concept...
Genomic and clinical sequencing adoption faces payer and implementation friction
Illumina’s Damon Hostin said clinical sequencing is positioned to enable more preemptive, preventative medicine, but insurance hurdles continue to limit widespread adoption. Hostin, head of market...
Regulatory approval
FDA has approved AstraZeneca’s baxdrostat for certain patients with hypertension, the company said Monday. The approval expands the regulatory footprint for baxdrostat and adds another option in...
Late-stage oncology failure
Regeneron’s phase 3 melanoma program for its LAG-3 inhibitor missed its primary endpoint, leaving the company facing a second late-stage failure for a key program after a setback within the past...