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BioWorld - Monday, February 6, 2023
Home » Topics » Infection » Coronavirus

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Regulatory front for March 26, 2020

March 26, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for March 26, 2020

March 26, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agnovos Healthcare, Biostage, Immunexpress, Prisma Health, Quidel, Vero Biotech.
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Other news to note for March 26, 2020

March 26, 2020
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ads Biotec, Atum, Babcock International Group, Cerus, Diazyme Laboratories, Exthera Medical, Grifols, Henry Schein, Ifirst Medical Technologies, Integragen, Ixlayer, Kurabo Industries, Lumos Diagnostics, Microbiosensor, Orthofix, Planet Innovation, Seqster, Suse, Twist Bioscience, Tyto Care, Wittenshein.
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$100 bill, portrait covered with mask

Stimulus bill responds to COVID-19 with more than $$$

March 26, 2020
By Mari Serebrov
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The stimulus bill passed by the U.S. Senate March 26 on a vote of 96-0 does more than throw $2.2 trillion into the war against COVID-19. “This is not … a stimulus package. It is emergency relief,” Senate Majority Leader Mitch McConnell (R-Ky.) said on the Senate floor before the vote.
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Regulatory front for March 26, 2020

March 26, 2020
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The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for March 26, 2020

March 26, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, APR, Arvelle, Astrazeneca, BMS, Innocoll, Intercept, Jazz, Orphan Technologies, Pear, Recordati, Relief.
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Other news to note for March 26, 2020

March 26, 2020
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agios, BD, Bellus Health, Benitec, Bioduro, Biomérieux, Biopharmx, Bluebird Bio, BMS, Boehringer Ingelheim, Celgene, Cerecor, Citius, Clarus, Delmar, Dynavax, Eisai, Evofem, Gilead, Grifols, GSK, J&J, Lift, Lipocine, Merck, Merck KGaA, Mylan, Myokardia, Novartis, Pfizer, Pharm-Olam, Revive, Saniona, Sanofi, Scholar Rock, Secarna, Twist, Unum, Xencor.
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In the clinic for March 26, 2020

March 26, 2020
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Bolt, Decibel, Healios, Imcheck, Inovio, Ipsen, Ironwood, Medimetriks, Oncopeptides, Otsuka, Qurient, Tolero, Uniqure, VBL.
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3-25-resmed-aircurve.png

Noninvasive ventilation options explored for COVID-19, as FDA eases with guidance

March 25, 2020
By Stacy Lawrence
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Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply its ventilation mask production by 10. But the San Diego-based company’s specialty is not mechanical ventilation that requires intubation, which is most commonly used in the intensive care unit (ICU), although it does produce some of those.
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Hand holding FDA blocks

Test developers frustrated by FDA’s resistance to at-home testing

March 25, 2020
By Mark McCarty
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The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
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