The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, COVID-19 EMA Pandemic Task Force, Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FDA, Heads of Medicines Agencies, National Institute for Health and Care Excellence, NIH, Therapeutic Goods Administration, U.S. Cyber Command, U.S. House and Senate, Wuhan Institute of Virology.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Quality Ontario, Imagination Engines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chronolife, Edwards Lifesciences, Exthera, Icecure, Life Spine, Lungpacer Medical, Medipines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Bioeclipse, Moderna, Moleculin, Pharmamar, Retrotope, Roche, Sanofi, Shionogi, Zambon.
PARIS – Braintale SAS, of Paris, has gained CE mark approval for Brainquant. This software platform, which uses DICOM radiology imaging, enables diffusion MRI scans to be processed as part of managing patients in a coma following brain injury.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Apollo Endosurgery, Ariosa, Illumina, Roche, Verinata Health.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Livanova, Personal Genome Diagnostics.
A once-daily add-on therapy for Parkinson's disease (PD) used in Europe for years has now gained clearance in the U.S. with FDA approval of Ongentys (opicapone). The drug, an improvement upon generics in its class, will be sold by Neurocrine Biosciences Inc. The medicine, a catechol-O-methyltransferase (COMT) inhibitor first approved by the EMA in 2016, extends the half-life of levodopa, increasing doses of which are required to achieve motor control as PD progresses. Portugal-based Bial-Portela & Ca SA, from which Neurocrine licensed North American rights to the drug, will receive a $20 million award from its partner. Shares of San Diego-based Neurocrine (NASDAQ:NBIX), a neuroscience company focused on treating movement disorders, rose 3.5% following the approval, closing at $101.67 on April 27.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Carmell, Carsgen, Cytodyn, Diffusion, Eiger, Green Valley, Halozyme, Janssen, Mateon, Neurocrine, Polyneuron, Takeda.
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