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Regulatory front for Nov. 7, 2019

Nov. 7, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Globe showing China

China grants conditional approval to Green Valley's GV-971 for Alzheimer's disease

Nov. 6, 2019
By Elise Mak
BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.
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Seoul, South Korea

Daewon wins Forteo biosimilar marketing approval in Korea

Nov. 6, 2019
By Jihyun Kim
HONG KONG – Daewon Pharmaceutical Co. Ltd., based in Seoul, South Korea, has received the approval from the country's Ministry of Food and Drug Safety (MFDS) to market Terrosa, a biosimilar teriparatide for osteoporosis treatment developed by Richter-Helm Biotec GmbH & Co. KG, of Hamburg, Germany.
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CMS backs away from rate cuts for PET in CY 2020 doc fee final

Nov. 6, 2019
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) has decided against a series of rate cuts for PET imaging in the Medicare physician fee schedule for 2020, a move lauded by physicians who were facing a rate cut of as much as 80% for nuclear medicine and molecular imaging procedures.
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Regulatory front for Nov. 6, 2019

Nov. 6, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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FDA approves Talicia for treatment of H. pylori in adults

Nov. 5, 2019

Regulatory front for Nov. 5, 2019

Nov. 5, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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FDA under temporary new leadership as Senate considers nominee

Nov. 5, 2019
By Mari Serebrov
How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more – Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.
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FDA offers greater clarity in revised draft for CDS software

Nov. 5, 2019
By Mark McCarty
The new draft guidance for clinical decision support (CDS) software is in part a response to the 21st Century Cures Act, and the FDA Bakul Patel said on a Nov. 4 webinar, "we heard the feedback loud and clear" on the previous draft, and thus the agency must "get this policy to a place where it balances patient safety" and the need to avoid unnecessary roadblocks between developers and the market.
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Regulatory front for Nov. 5, 2019

Nov. 5, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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