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Regulatory
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Earth threatened by virus

COVID-19 could prove an expensive distraction for life sciences

Feb. 18, 2020
By Mark McCarty
The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable.
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Regulatory front for Feb. 18, 2020

Feb. 18, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: 10X Genomics, Bio-Rad Laboratories, Sanofi SA.
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Silhouette made of crumpled paper illustrating depression

Fisher Wallace files citizen petition over FDA’s class III designation for CES

Feb. 18, 2020
By Mark McCarty
Fisher Wallace Laboratories of New York has filed a citizen’s petition with the U.S. FDA regarding the agency’s proposed class III designation for cranial electrotherapy stimulators (CES) for treatment of depression. The company argued that the agency disallowed evidence at an advisory hearing regarding this therapy provided by direct rather than alternating current, but also that the FDA had reneged on an earlier decision to classify these devices as class II devices.
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Regulatory front for Feb. 18, 2020

Feb. 18, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Sanofi, Sandoz.
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Regulatory front for Feb. 14, 2020

Feb. 14, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Brainsway, National Government Services, Wisconsin Physician Services.
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Belviq bows out of U.S. market amid cancer concerns

Feb. 14, 2020
By Mari Serebrov
Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
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Regulatory front for Feb. 13, 2020

Feb. 13, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Tyvek Medical.
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U.S. health compass

Azar: Grassley-Wyden bill leaves ‘plenty of room’ for profits, innovation

Feb. 13, 2020
By Mark McCarty
Health and Human Services (HHS) Secretary Alex Azar was peppered with questions about the Trump administration’s budget proposal for fiscal 2021 during a Feb. 13 Senate hearing. However, another theme that resonated during the hearing was Senate legislation addressing drug prices. Azar addressed the issue of price caps, while noting that the bill “leaves plenty of room” for both ample profit margins and innovation in drug development.
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Regulatory front for Feb. 13, 2020

Feb. 13, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Feb. 12, 2020

Feb. 12, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cook, Medtronic, Tenet Healthcare.
Read More
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