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BioWorld - Tuesday, December 23, 2025
Breaking News: BioWorld 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
Home » Topics » BioWorld, Regulatory

BioWorld, Regulatory
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U.S. flag on columned building

2020 Special 301 report calls out the usual U.S. trade partners for IP offenses

April 29, 2020
By Mari Serebrov
Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.
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Wall Street hails Chimerix viral load; COVID-19, smallpox bids forge onward

April 29, 2020
By Randy Osborne
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
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Regulatory front for April 29, 2020

April 29, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for April 29, 2020

April 29, 2020
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.
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Regulatory actions for April 28, 2020

April 28, 2020
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.
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Regulatory front for April 28, 2020

April 28, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Chugai, Fresenius, Genentech, Pfizer, Quva, Roche, Vertex.
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Steadying hand while reaching for glass

Neurocrine expands commercial portfolio, winning U.S. approval for Parkinson's drug

April 27, 2020
By Michael Fitzhugh
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.
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Regulatory actions for April 27, 2020

April 27, 2020
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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Laptop, stethoscope, medical icons, health professional

CMS, ONC offer enforcement discretion for EHR rules

April 24, 2020
By Mark McCarty
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.
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Regulatory actions for April 24, 2020

April 24, 2020
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.
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