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Home » Topics » Regulatory

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Regulatory front for Feb. 24, 2020

Feb. 24, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Cybersecurity data lock

Cybersecurity requirements, liabilities expanding for device makers

Feb. 24, 2020
By Mark McCarty
U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation.
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2-24-Cardiovalve.png
CRT20

Cardiovalve wins FDA breakthrough nod for tricuspid valve replacement technique

Feb. 24, 2020
By Meg Bryant
NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
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De novo key on keyboard

FDA gives nod to Asuragen’s Amplidex Fragile X Dx and Carrier Screen Kit

Feb. 24, 2020
By Liz Hollis
Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency.
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Brain illustration

Lundbeck’s newly approved Vyepti enters a growth market for migraine prevention

Feb. 24, 2020
By Lee Landenberger
H. Lundbeck A/S’ antibody-based migraine therapy, Vyepti (eptinezumab-jjmr), which just received FDA approval as the first and only intravenous preventive treatment for adults, enters a market forecast to grow to $7 billion by 2027. While some analysts placed Vyepti’s earnings potential at about $800 million annually, the drug itself is positioned to become a possible blockbuster, earning $1 billion annually.
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Regulatory front for Feb. 24, 2020

Feb. 24, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Eastgate, Lilly, Pixarbio, Steba.
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Blood sample, DNA

Biomarin’s BLA for Valrox gene therapy for hemophilia A accepted by FDA

Feb. 24, 2020
By Peter Winter
Valrox (valoctocogene roxaparvovec) from San Rafael Calif-based Biomarin Pharmaceutical Inc. moved one step closer to entering the U.S. market, with the company reporting that that the FDA had accepted for priority review the BLA for its investigational AAV5 gene therapy for adults with hemophilia A.
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FDA approves Vyepti for preventive treatment of migraine

Feb. 24, 2020

FDA approves Nexletol to lower LDL-C in patients with HeFH or ASCVD

Feb. 24, 2020

Neoral approved for acute stage Kawasaki disease in Japan

Feb. 24, 2020
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