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Regulatory front Oct. 23, 2019

Oct. 23, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front

Oct. 23, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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I-Mab scores second China IND with its CD38 antibody

Oct. 23, 2019
By David Ho
HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).
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FDA approves Trikafta for cystic fibrosis

Oct. 22, 2019

Regulatory front Oct. 22, 2019

Oct. 22, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Assertio stock continues downward slide after CRL

Oct. 22, 2019
By Lee Landenberger
The complete response letter (CRL) received by Assertio Therapeutics Inc.'s development partner, West Therapeutic Development LLC, regarding its NDA for cosyntropin (synthetic adrenocorticotropic hormone, ACTH) knocked Assertio's stock back 28% on Monday.
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Regulatory front

Oct. 22, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Little predictability in IRB use of 'appropriate local committees'

Oct. 22, 2019
By Mark McCarty
The FDA's September 2019 final guidance for the humanitarian device exemption program brought some clarity to several issues, but device makers must still untangle the question of which tasks an institutional review board (IRB) has delegated to an appropriate local committee for a specific clinical site.
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Canon Medical nabs FDA OK for AI-enhanced Aquilion Precision CT

Oct. 22, 2019
By Meg Bryant
The U.S. FDA has given 510(k) clearance to the Advanced Intelligent Clear-IQ Engine (AiCE) for Canon Medical Systems USA Inc.'s Aquilion Precision CT scanner. The regulatory green light brings artificial intelligence (AI)-based image reconstruction capabilities to the world's first ultra-high resolution CT imaging system.
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Ebola vaccination in Democratic Republic of Congo

CHMP backs EU approval for Merck's Ebola vaccine at October meeting

Oct. 21, 2019
By Cormac Sheridan
DUBLIN – Merck & Co. Inc. is in line to obtain conditional marketing authorization from the European Union for its live attenuated vaccine for preventing Ebola virus infection, V920 Ebola Zaire vaccine (rVSVDG-ZEBOV-GP live), following a positive recommendation for approval from the EMA's Committee for Human Medicinal Products (CHMP) at its October meeting last week. Formal approval should follow within 67 days, after which the Kenilworth, N.J.-based pharma would market the vaccine as Ervebo.
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