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BioWorld - Monday, January 12, 2026
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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Regulatory front for Aug. 17, 2020

Aug. 17, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for Aug. 17, 2020

Aug. 17, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied, BTG, Emergent, G1, Henlius, Immunomedics, Mustang, Myovant, PTC, Roche, Tracon, Trinity, United.
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Regulatory actions for Aug. 14, 2020

Aug. 17, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Kempharm, Mesoblast, TLC, Verona.
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FDA icons

Mesoblast blazes adcom trail for MSC therapy

Aug. 17, 2020
By Mari Serebrov
While the FDA’s Oncologic Drugs Advisory Committee (ODAC) shared some of the agency’s concerns about uncertainties surrounding Mesoblast Ltd.’s Ryoncil (remestemcel-L), it voted 9-1 Aug. 13 that the mesenchymal stromal cell (MSC) product showed evidence of efficacy as a treatment for steroid-refractory acute graft-vs.-host disease (GVHD) in children.
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Nanotechnology illustration

FDA works to leverage nanotech investment, better capacity for evaluation

Aug. 13, 2020
By Michael Fitzhugh
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.
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Regulatory actions for Aug. 13, 2020

Aug. 13, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Akeso, Antengene, Biomarin, Enzychem, Genentech, Hoth, Micurx, NS, Passage, Scholar Rock, TG.
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Stock chart, compass

‘Bearing’ down: With the NRF2 persist after dicey FDA updates, Reata well enough left -olone?

Aug. 12, 2020
By Randy Osborne
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.”
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Will the lessons of COVID-19 be taken to heart this time?

Aug. 12, 2020
By Mari Serebrov
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
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Regulatory front for Aug. 12, 2020

Aug. 12, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More

Regulatory actions for Aug. 12, 2020

Aug. 12, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Arca, Ascendis, Eli Lilly, Epirium, Eyegate, Indian, Innovent, Kahr, Kineta, Pliant, Redhill, Regeneron, Seattle Genetics, Theranexus.
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