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BioWorld - Wednesday, May 6, 2026
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Regulatory front for Dec. 3, 2019

Dec. 3, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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U.S. flag, stethoscope

Stakeholders press CMS to allow repeat testing in do-over of NGS coverage memo

Dec. 2, 2019
By Mark McCarty
The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.
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China updates reimbursement drug list, further encourages innovation at home

Dec. 2, 2019
By Elise Mak
BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.
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Regulatory front for Dec. 2, 2019

Dec. 2, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Dec. 2, 2019

Dec. 2, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Chidamide approved in China for breast cancer indication

Dec. 2, 2019

NMPA approves flumatinib mesylate for the treatment of Ph+ chronic myeloid leukemia

Nov. 29, 2019

Subcutaneous infliximab biosimilar approved in the E.U. for the treatment of RA

Nov. 28, 2019

Celltrion’s Remsima SC wins marketing approval in EU

Nov. 27, 2019
By Jihyun Kim
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.
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Regulatory front for Nov. 27, 2019

Nov. 27, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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