BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection).
The latest global regulatory news, changes and updates affecting biopharma, including: Biotechnology Innovation Organization, FDA, Institute for Clinical and Economic Review, Medicines and Healthcare Products Regulatory Agency.
PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity.
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Justice, Dusa, FDA, Michbio, Russian Ministry of Health, SEC, Stericycle Expert Solutions, Wintac.
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Health and Human Services, Drug Enforcement Administration, FDA, Health Canada, National Center for Advancing Translational Sciences, SK Biopharma.
HONG KONG – Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease.
The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter (CRL) highlighting safety concerns.
The latest global regulatory news, changes and updates affecting biopharma, including: Medicines and Healthcare Products Regulatory Agency, Moderna, Office of the U.S. Trade Representative, Pan American Health Organization, SEC, Therapeutic Goods Administration, World Health Organization.
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz.
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