PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Apogenix, Ascletis, Aytu Bioscience, Calidi, Celltrion, Direct Biologics, Edesa, Eisai, Merck, Foresee, Hutchison China Meditech, Poxel, Sumitomo Dainippon, Realta Life Sciences, Relief, Neurorx, Revive, Sound, Takeda, Teva.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: AI, Ampio, Ascentage, Cerecor, Clarity, Cytodyn, Hutchison China Meditech, Immunic, Moderna, Opthea.
The latest global regulatory news, changes and updates affecting biopharma, including: Medicines and Healthcare Products Agency, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
HONG KONG – California-based Iacta Pharmaceuticals Inc. and Hong Kong-based Zhaoke Ophthalmology Pharmaceutical Ltd. have inked a definitive license agreement for two of Iacta’s products.