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Architectural pillars

Regulatory front for March 31, 2020

March 31, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Association for Accessible Medicines, Department of Justice, EMA, FDA, Federal Trade Commission, International Coalition of Medicines Regulatory Authorities, SEC, White House, World Health Organization.
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3-31-Siemens-RAPIDPoint-500e.png

FDA gives nod to Siemens Healthineers’ Rapidpoint 500e blood gas analyzer

March 31, 2020
By Meg Bryant
Erlangen, Germany-based Siemens Healthineers AG has secured U.S. FDA clearance for its Rapidpoint 500e blood gas analyzer. Available in CE mark countries since August 2019, the device is used to monitor respiratory distress in critically ill patients, such as those in acute care due to COVID-19.
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Regulatory front for March 31, 2020

March 31, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Becton Dickinson, Biotechnology Innovation Organization, Cme America, Ortho-Clinical Diagnostics.
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Amarin stock plummets on district court’s patent ruling on Vascepa

March 31, 2020
By Lee Landenberger
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
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Regulatory front for March 31, 2020

March 31, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Pfizer Healthcare India.
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FDA approves Taltz for pediatric patients with plaque psoriasis

March 31, 2020
Coronavirus microscopic model

Ottawa issues order accelerating delivery of U.S. made COVID-19 test kits

March 30, 2020
By David Godkin
TORONTO – The Government of Canada is fast tracking importation of two U.S. manufactured test kits for COVID-19, issuing an interim order for sale of the Cobas SARS-CoV-2 diagnostic test kit developed by Pleasanton, Calif.-based Roche Molecular Systems Inc. and Waltham, Mass.-based Thermo Fisher Scientific Inc.’s Taqpath COVID-19 Combo Kit.
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Regulatory front for March 30, 2020

March 30, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic.
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FDA urges further steps to avoid drug shortages

March 30, 2020
By Mari Serebrov
To mitigate COVID-19-related drug shortages, the FDA issued new guidance reminding drug and biologic manufacturers of their legal obligations to notify the agency, in advance, of interruptions or the permanent discontinuance in the manufacturing of certain drugs. It also makes some new recommendations in light of the current emergency.
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Regulatory front for March 30, 2020

March 30, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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