Regulatory - Articles - Page 286

Regulatory actions for Nov. 21, 2023

Nov. 21, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medical, GE Healthcare, Medtronic, Pixyl, Supira Medical.

Cardinal Health Monoject Disposable Syringes

FDA cautions against Cardinal Health Monoject syringe use

Nov. 21, 2023

By Mark McCarty

The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps.

FDA predetermined change control program major shift for med-tech

Nov. 21, 2023

By Mark McCarty

The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc.

Cross section illustration of HIV virus parts

HIV/AIDS

Arenaviral therapeutic vaccine HB-500 gets IND clearance for HIV

Nov. 21, 2023

Hookipa Pharma Inc. has received clearance from the FDA for its IND application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.

Substance Use & Poisoning

NT-I7 awarded US orphan drug designation for radiation poisoning

Nov. 21, 2023

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.

Polaris begins rolling BLA for ADI-PEG 20 for pleural mesothelioma

Nov. 20, 2023

By Tamra Sami

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.

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

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.

UK pricing scheme an ‘important compromise’ that supports innovation

Nov. 20, 2023

By Nuala Moran

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.

Medtronic rolls out Spyral in US after circuitous journey

Nov. 20, 2023

By Mark McCarty

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.

MFDS leads global AI-based med device standardization effort

Nov. 20, 2023

By Marian (YoonJee) Chu

South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software.