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BioWorld - Friday, December 5, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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BioWorld Asia, Regulatory
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Mylan gets remdesivir approval for COVID-19 in India

July 14, 2020
By David Ho
HONG KONG – The Drug Controller General of India (DCGI) has approved Mylan NV’s remdesivir 100-mg vial for restricted emergency use in COVID-19 cases.
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Architectural pillars

Regulatory front for July 14, 2020

July 14, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, International Coalition of Medicines Regulatory Authorities.
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Architectural pillars

Regulatory front for July 7, 2020

July 7, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Apotex, DoJ, EMA, Glenmark, U.S. House, Senate, South Korea’s Ministry of Food and Drug Safety, Trump administration.
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Japanese flag

Japan’s MLWH ends June with string of approvals, looks set for busy 2H 2020

July 7, 2020
By Gina Lee
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
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Architectural pillars

Regulatory front for June 30, 2020

June 30, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Alcon, Gilead Sciences, Institute for Clinical and Economic Review, Novartis, SEC.
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India-pill-bottle-drugs

India’s Glenmark Pharmaceuticals gets green light to launch $1 COVID-19 treatment tablets

June 23, 2020
By David Ho
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
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Architectural pillars

Regulatory front for June 23, 2020

June 23, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Auromedics, Bring Entrepreneurial Advancements to Consumers Here In North America, Central Drugs Standard Control Organisation, FDA, Gilead Sciences, Medicines and Healthcare products Regulatory Agency, NIH, Pharmaceutical and Medical Devices Agency, Somerset, Therapeutic Goods Administration, U.S. Patent and Trademark Office.
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Architectural pillars

Regulatory front for June 16, 2020

June 16, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Defense, FDA, Minister of Health, National Center for Advancing Translational Sciences, NIH.
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India posts draft rules for compassionate use of unapproved drugs

June 16, 2020
By David Ho
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.
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Beigene’s FDA-cleared BTK inhibitor Brukinsa approved in China

June 9, 2020
By Elise Mak
Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
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