Top News
FDA approves Lantheus radiodiagnostic for identifying tau pathology in cognitively impaired patientsDiagnostic enables detection of tau neurofibrillary tangles to stratify early Alzheimer's disease.
Sandoz partners with Henlius in $322M biosimilar collaboration covering up to 10 assets amid patent cliff opportunitiesDeal targets global loss-of-exclusivity window for reference biologics; Henlius contributes development and manufacturing expertise.
More: Pharmaceutical Executive
Moderna's mRNA flu vaccine clears FDA but faces strain-selection timing and adoption headwindsTiming of annual strain selection and residual mRNA skepticism could constrain blockbuster potential despite regulatory approval.
EMA validates Pfizer and Valneva's Lyme disease vaccine PF-07307405 marketing authorization applicationFirst Lyme disease vaccine candidate in Europe to reach EMA validation stage; regulatory decision expected in coming months.
Fannin Partners secures CDMRP and Faris Foundation grants for RapDC therapy in Ewing sarcomaTwo new grants advance development of targeted Raptamer-drug conjugate for rare pediatric bone cancer.
Nurexone releases preclinical tissue analysis supporting Exopten's neuroprotective effect in spinal cord injuryNew biological data from exosome-based therapeutic candidate strengthens mechanistic rationale for acute SCI indication.
FDA grants Fast Track designation and IND clearance to AC Immune's anti-alpha-synuclein immunotherapy ACI-7104 for early Parkinson'sFast Track expedites development of first-in-class active immunotherapy targeting pathological protein in neurodegenerative disease.
Cancer Research UK, KisoJi Biotechnology launch Phase I/IIa trial of KJ-103, naked anti-TROP2 heavy-chain-only antibodyFirst-in-class format targeting TROP2-expressing solid tumours; trial enrolment now underway.
Infinitopes doses first patient with ITOP1, precision therapeutic vaccine for oesophageal cancerLead candidate leverages Infinitopes' Precision Immunomics platform combining large-scale immunopeptidomic profiling.
FDA grants fast track designation to Phanes' spevatamig for advanced biliary tract cancerFast track status accelerates review timeline for the candidate in metastatic BTC, a rare indication with limited treatment options.
- NIH ends K-series career awards for clinical trials, restricting early-stage researcher funding pathway
Move affects junior investigators' ability to conduct patient-centered studies during critical career-building phase.
FDA grants accelerated approval to Bristol Myers' Zenbexus (iberdomide), first CELMoD class drug for advanced multiple myelomaZenbexus, acquired from Celgene, marks debut of protein-degrading CELMoD class and rejuvenates key BMS franchise.
More: BioPharma Dive, BioWorld, BioWorld, Pharmaceutical Executive, Pharmaceutical Technology
FDA signals willingness to review Capricor's updated deramiocel submission for DMD cardiomyopathy based on open-label extension dataCEO cited FDA openness to resubmission after OLE results; allogeneic cell therapy previously faced regulatory headwinds.
More: BioWorld
JW Pharmaceutical's epaminurad meets Phase III primary endpoint versus febuxostat in head-to-head gout studyURAT1 inhibitor epaminurad (URC-102) 6 mg outperformed febuxostat 40 mg; JW planning Korea NDA filing in competitive late-stage gout space.
BioNTech appoints Guido Oelkers CEO as company pivots toward oncology with $19B cash runwayOelkers takes helm amid declining vaccine sales but inherits deep cancer pipeline and substantial balance sheet.
Claret Capital Partners provides €30M structured debt to Carvolix for Tavipilot Robot FDA submission and commercializationFunding extends runway to support key milestones including FDA submission for surgical robotics platform and early sales ramp.
- FDA grants IND clearance for Dogwood's SP-16 in chemotherapy-induced pain and peripheral neuropathy
Dogwood disclosed approval in earnings; SP-16 advances to clinical testing in pain management indication.
NIAID awards contract to Arisan Therapeutics for oral Ebola antiviral developmentGovernment backing advances Arisan's broad-spectrum small-molecule candidate toward IND-enabling studies.
BMS establishes manufacturing hub in Houston as Regeneron backs startup developing Dupixent competitorBMS expands U.S. production capacity while Regeneron signals competitive pressure on its blockbuster IL-4 receptor antagonist.
- Hengrui patents BTK-targeting PROTAC compounds for BTK-driven hematologic malignancies
Proteolysis-targeting approach offers potential for overcoming resistance to first-generation BTK inhibitors.
- D3 Bio synthesizes pan-KRAS inhibitors for oncology applications
Broad-spectrum GTPase inhibition approach aims to overcome resistance mechanisms in KRAS-mutant solid tumors.
- United Bio-Technology develops GLP-1R agonists targeting metabolic disease, cardiovascular, liver, renal, and neurodegeneration indications
Pipeline expansion into multi-organ indication space capitalizes on validated GLP-1R mechanism beyond diabetes and obesity.
Allist Pharmaceuticals licenses Arrivent's ARR-002 for exclusive China development and commercialization rightsArrivent's AST-12608 (ARR-002) marks strategic entry into Chinese market under Shanghai-based partner.
Immunology specialist Khartis Therapeutics emerges from stealth with $95M Series A funding roundFounded by team from XinThera (acquired by Gilead), Khartis launched two years ago and is focused on immunology-driven therapeutics.
Drug-testing lab sues U.S. Pharmacopeia over criticism of its impurity-detection methodsThe lab has previously clashed with regulators over findings of contaminants in widely used medicines.