NeuroSense Therapeutics is using clinical and biomarker findings from its Phase 2b PARADIGM programme to refine the planned Phase 3 PARAGON trial of PrimeC. The published study reported encouraging long-term functional differences, but its six-month comparison was not statistically significant and the company faces substantial financing and listing pressures.
The FDA has accepted FYB206, a proposed biosimilar to Merck's Keytruda, for review, with a decision potentially due in the third quarter of 2027. Zydus and Formycon pursued a streamlined development programme without a comparative Phase 3 efficacy trial, but approval, patent clearance and commercial launch remain separate hurdles.
Affinia advances AFTX-201 into a 22-patient BAG3 heart gene therapy trial after promising animal results. Human safety and efficacy remain unproven.
Health Canada has issued Class II medical-device licenses for Fujirebio’s Lumipulse G pTau217 Plasma and NfL Blood assays, expanding automated blood-based neurological testing for Alzheimer’s pathology and neuro-axonal injury.
Japan expands ORLADEYO to children aged 2 to under 12 as BioCryst Pharmaceuticals builds its global HAE franchise. See what comes next.
Nanochon gains Panama authorization for a five-patient Chondrograft study as its cartilage implant moves deeper into first-in-human testing.
Kardium wins Health Canada approval for the Globe Pulsed Field System, extending its integrated atrial fibrillation platform beyond the U.S.
Rejuva Fresh secures Health Canada licence 115678 for PicoPretty, opening Canadian sales while clinics assess evidence, training and ROI.
Affinia Therapeutics gains FDA orphan status for AFTX-201 as the UPBEAT trial tests gene therapy for BAG3 dilated cardiomyopathy.
Read how Health Canada’s BESREMi approval could reshape polycythemia vera treatment, reimbursement and PharmaEssentia’s Canadian strategy.