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Home » Topics » Regulatory

Regulatory
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Regulatory actions for Nov. 3, 2023

Nov. 3, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Empatica, Polaris.
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Immuno-oncology

Prokarium’s ZH-9 cleared to enter clinic in US for bladder cancer

Nov. 3, 2023
Prokarium Ltd. has obtained FDA clearance of its IND application for ZH-9 for patients with non-muscle invasive bladder cancer.
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Antibody-drug conjugate
Immuno-oncology

Angiex cleared to begin phase I study of TM4SF1-directed ADC

Nov. 3, 2023
Angiex Inc. has received FDA clearance of its IND application for AGX-101, a novel TM4SF1-directed antibody-drug conjugate (ADC) being developed for the treatment of solid cancers.
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Dollar sign inside vial, syringe

Interchangeable to challenge Stelara, impact of price negotiations still a question

Nov. 2, 2023
By Mari Serebrov
Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab).
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Voquezna

Voquezna GERD approval in hand, Phathom set to launch by year-end

Nov. 2, 2023
By Randy Osborne
Phathom Pharmaceuticals Inc. will begin marketing Voquezna (vonoprazan) in December, thanks to the Nov. 1 approval by U.S. regulators, who cleared the potassium-competitive acid blocker at 10-mg and 20-mg doses for all grades of erosive gastroesophageal reflux disease (GERD), maintenance of healing of all grades of the condition and relief of associated heartburn.
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OMB memo on AI suggests need for more IT capacity at US FDA

Nov. 2, 2023
By Mark McCarty
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.
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Laptop displaying FDA logo
FDLI Advertising and Promotion Conference

US DOJ: company history, potential for harm drive criminal charges for marketing

Nov. 2, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) has a unique role in enforcement of medical product communication even though the department shares oversight of medical product promotions with the FDA and the Federal Trade Commission (FTC).
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sibionics cgm

Sibionics lands CE mark for GS1 CGM system

Nov. 2, 2023
By Marian (YoonJee) Chu
Sibionics Technology Co. Ltd. said it received the CE mark for its continuous glucose monitoring (CGM) system, coined the Sibionics GS1 CGM, helping the company expand its market opportunities beyond China.
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Regulatory actions for Nov. 2, 2023

Nov. 2, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Toku.
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RNA strand
Neurology/Psychiatric

FDA awards orphan drug designation to Huidagene’s CRISPR RNA-editing therapy for MECP2 duplication syndrome

Nov. 2, 2023
The FDA has awarded U.S. orphan drug designation and rare pediatric disease designation to Huidagene Therapeutics Co. Ltd.’s HG-204 (AAV-hfCas13Y-gMECP2), an RNA editing therapy based on CRISPR/Cas13Y, for the treatment of methyl-CpG binding protein 2 (MeCP2) duplication syndrome (MDS).
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