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Home » Topics » Regulatory

Regulatory
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Camrelizumab approved in China for advanced hepatocellular carcinoma

March 6, 2020

Indian approval of saroglitazar for noncirrhotic NASH

March 6, 2020

Regulatory front for March 5, 2020

March 5, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More
Brain clay model

Neuren and Acadia’s trofinetide wins FDA rare pediatric disease designation for Rett syndrome as phase III testing advances

March 5, 2020
By Tamra Sami
PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.
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Regulatory front for March 5, 2020

March 5, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More

Regulatory front for March 4, 2020

March 4, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Clinical Laboratory Association, DNA Technologies, Texas Instruments, Dialog Semiconductors, Telink Semiconductors.
Read More
Doctor pointing at liver

Roche scores breakthrough device designation for Elecsys GALAD score

March 4, 2020
By Liz Hollis
With an eye toward helping those with early stage hepatocellular carcinoma (HCC), Basel, Switzerland-based Roche Group has won a breakthrough device designation from the U.S. FDA for the Elecsys GALAD score. When combined with ultrasound, the Elecsys GALAD score aims to help provide more accurate information for clinicians to treat patients at an earlier stage.
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Japanese flag

Japan’s medical device price cut set to be smaller in 2020

March 4, 2020
By Jihyun Kim
HONG KONG – Japan cuts medical device prices every two years to manage increasing health care costs. This year, the biennial medical device price cut will take effect beginning on April 1, 2020.
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Map, flag of India

India restricts export of certain APIs; expert says ‘It’s not a ban’

March 4, 2020
By David Ho and Elise Mak
HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs. In a note dated March 3, India’s Directorate General of Foreign Trade compiled a list of now restricted APIs and formulations that were previously free to export. It ranged from paracetamol and erythromycin salts to progesterone and vitamin B1, 6 and 12.
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Regulatory front for March 4, 2020

March 4, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: Merck & Co., Outlook Pharmaceuticals.


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