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BioWorld - Thursday, March 23, 2023
Home » Topics » Regulatory

Regulatory
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Un-Enspryng? Street hails Roche’s new subcu but still enthused re infused for NMOSD

Aug. 17, 2020
By Randy Osborne
No Comments
The FDA’s go-ahead for Roche Holding AG’s Enspryng (satralizumab-mwge) in anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder had watchers of the space weighing its market odds against two therapies approved earlier: Soliris (eculizumab) from Boston-based Alexion Pharmaceuticals Inc., and the more recently cleared Uplizna (inebilizumab-cdon) from Viela Bio Inc., of Gaithersburg, Md.
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Regulatory front for Aug. 17, 2020

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

Aug. 17, 2020
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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
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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
No Comments
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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Hospital patient, device image

Masimo gets FDA nod for fluid responsiveness indicator

Aug. 14, 2020
By Meg Bryant
No Comments
The U.S. FDA has granted 510(k) clearance to Masimo Corp. for its PVi software tool as a continuous, noninvasive, real-time indicator of fluid responsiveness in select populations of mechanically ventilated adults. PVi, which is an acronym for pleth variability index, quantifies the dynamic changes in perfusion index that occur in a patient during the respiratory cycle.
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Regulatory front for Aug. 14, 2020

Aug. 14, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: RS Medical.
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Regulatory actions for Aug. 14, 2020

Aug. 14, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo.
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Globe showing Asia-Pacific region

‘Made-in’ policies for medical devices spreading across Asia-Pacific region

Aug. 13, 2020
By Mark McCarty
No Comments
The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.
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Nanotechnology illustration

FDA works to leverage nanotech investment, better capacity for evaluation

Aug. 13, 2020
By Michael Fitzhugh
No Comments
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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