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Regulatory
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China approves first homegrown COVID-19 vaccine to enter clinical trials

March 18, 2020
By Elise Mak
BEIJING – One day after the U.S. began the first human trial of an mRNA vaccine candidate for COVID-19 on March 16, China said Tuesday evening that it had approved the first clinical trial of a vaccine candidate developed by domestic researchers.
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Regulatory front for March 18, 2020

March 18, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Astrazeneca, Boehringer Ingelheim, Janssen, Lilly, Merck.
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Earth infected with pandemic

Officially a pandemic, but COVID-19 fight far from over, says WHO director general

March 17, 2020
By Nuala Moran
LONDON – The World Health Organization (WHO) has officially declared COVID-19 a pandemic, but is pushing back strongly against countries giving up on stringent control measures.
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Architectural pillars

Regulatory front for March 17, 2020

March 17, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: U.S. Trade Representative, World Trade Organization.
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South Korean shield, coronavirus

South Korea approves first four COVID-19 test kits under urgent-use license

March 17, 2020
By Gina Lee
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
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3-17-Beyond-Air-Lung-BRO.png

Beyond Air seeks IDE for nitric oxide treatment for COVID-19

March 17, 2020
By Meg Bryant
As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
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3-17-BeholdAI-red-dot.png

Behold.ai secures 510(k) for Red Dot image recognition algorithm

March 17, 2020
By Nuala Moran
LONDON – Behold.ai Ltd. has secured U.S. FDA 510(k) approval for use of its Red Dot image recognition algorithm in the automatic diagnosis of life-threatening pneumothorax (collapsed lung). The product completes the analysis immediately, sending an alert to the radiologist as soon as an X-ray is taken. “It does in 30 seconds what would normally take up to 30 minutes,” said Simon Rasalingham, CEO of London-based Behold.ai.
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Peanut allergy

Nuts! DBV to peel adhesive (red) tape from allergy bid; stock plunges

March 17, 2020
By Randy Osborne
DBV Technologies SA officials took pains to reassure investors that data wanted by the FDA with regard to the BLA for Viaskin Peanut allergy therapy are already in hand and need only be turned over to the agency, but that didn’t stop shares (NASDAQ:DBVT) from sliding 55.7%, or $2.93, to close March 17 at $2.33.
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Regulatory front for March 17, 2020

March 17, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics.
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Regulatory front for March 17, 2020

March 17, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Illumina, Sequenom, Roche, Boehringer Ingelheim, Mylan.
Read More
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