Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amylyx, ANI, Azurrx, Beyondspring, Capricor, Chimerix, Erytech, Merck, Neuraptive, Novartis, Ortho Dermatologics, Remegen.
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.
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.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Biosig, Innovent, Janssen, Lilly, Oryzon, Sanofi, Viralclear.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amidebio, Caladrius, CNS Pharma, Cstone, Immuneoncia, Immunomedics, Merck and Co., Rafael, Revive, Samsung Biologics, Vitalis.
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