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Regulatory actions for Nov. 21, 2023

Nov. 21, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medical, GE Healthcare, Medtronic, Pixyl, Supira Medical.
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Substance Use & Poisoning

NT-I7 awarded US orphan drug designation for radiation poisoning

Nov. 21, 2023
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The FDA has awarded orphan drug designation to Neoimmunetech Inc.'s NT-I7 (efineptakin alfa, rhIL-7-hyFc) for the treatment of acute radiation syndrome (ARS). NT-I7, a novel long-acting recombinant human IL-7, has the potential to rapidly recover and improve the immune response following a high dose of radiation exposure.
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Polaris begins rolling BLA for ADI-PEG 20 for pleural mesothelioma

Nov. 20, 2023
By Tamra Sami
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Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
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FDA Approved stamp with pills
Biopharma regulatory actions and approvals October 2023

US FDA approves 27 drugs in October, marking highest month since 2020

Nov. 20, 2023
By Amanda Lanier
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In October, U.S. FDA approvals experienced a significant upswing, reaching a total of 27 for the month, a 92.86% increase from 14 approvals recorded by BioWorld in September. In the initial 10 months of this year, FDA approvals hit 155, an increase of 22.05% from the 127 drugs approved last year, although approvals are down from 2018-2021. Approved new molecular entities are at 29 in 2023, up from 28 in the corresponding period last year but a decline from 2017-2021.
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Pill with British pound sign

UK pricing scheme an ‘important compromise’ that supports innovation

Nov. 20, 2023
By Nuala Moran
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The long-running row over the U.K. voluntary scheme that controls the national drugs budget has been settled, in what the industry is describing as a “tough deal.” Under the scheme there is an annual cap on total sales of branded drugs to the National Health Service, with sales over the agreed limit reimbursed via a levy. In 2022, pharma companies paid back £2 billion (US$2.5 billion) in rebates on total sales of £14 billion. In the new five-year agreement, the allowed annual increase in sales will be 2% in 2024, the same as across the current scheme from 2019 – 2023, but it will then increase to 4% by 2027.
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Medtronic - Symplicty Spyral HTN

Medtronic rolls out Spyral in US after circuitous journey

Nov. 20, 2023
By Mark McCarty
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The renal denervation hypothesis of hypertension was initially viewed with some skepticism, and Dublin-based Medtronic plc. endured a major setback when clinical trial data failed to make a compelling case for approval for the Symplicity Spyral. However, the company finally landed an FDA approval for the device, opening the gates to a new and significant market opportunity even with competition already on the market.
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