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Home » Topics » Regulatory

Regulatory
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OIG: US NIH audit oversight puts federal funds at risk

Dec. 22, 2023
By Mari Serebrov
If two recent reports about the NIH’s oversight of its grant programs were grades, the U.S. agency would have received failing marks – again.
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FDA Approved stamp
Biopharma regulatory actions and approvals November 2023

FDA nods remain up from last year, yet lag behind 2017-2021

Dec. 22, 2023
By Amanda Lanier
In November, the U.S. FDA approved a total of 12 drugs, a decrease from 27 the previous month that marked the highest number of approvals since June 2020, as reported by BioWorld. From January to November, FDA approvals reached 167, an increase of 21.9% from 137 drugs approved during the same time period the previous year.
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Ionis’ Wainua approved in US for rare disease hATTR-PN

Dec. 22, 2023
By Karen Carey
A new self-injectable therapy for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) will be available in January 2024 now that the U.S. FDA has approved Ionis Pharmaceuticals Inc.’s Wainua (eplontersen), a ligand-conjugated antisense oligonucleotide.
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Laptop displaying FDA logo

FDA final guidances address digital health and more

Dec. 22, 2023
By Mari Serebrov
With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the use of digital health technology in clinical trials to the use of real-world data (RWD) in drug development.
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Philps Panorama 1

Explosive news: Philips issues class I recall of Panorama 1.0T

Dec. 22, 2023
By Annette Boyle
More bad news on the recall front for Royal Philips NV, as the U.S. FDA this week categorized the company’s voluntary recall of its Panorama 1.0T HFO open magnetic resonance (MR) system as a class I action. Class I recalls indicate the “use of the devices may cause serious injuries or death,” the FDA noted.
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Regulatory actions for Dec. 22, 2023

Dec. 22, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclarent.
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Nephrology

Arrowhead files to begin phase I/IIa trial of ARO-CFB for complement-mediated renal disease

Dec. 22, 2023
Arrowhead Pharmaceuticals Inc. has filed an application in New Zealand seeking clearance to initiate a phase I/IIa trial of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for complement-mediated renal disease, such as immunoglobulin A nephropathy (IgAN).
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Musculoskeletal

Aurinia submits IND for AUR-200 for autoimmune diseases

Dec. 22, 2023
Aurinia Pharmaceuticals Inc. has submitted an IND application to the FDA for AUR-200, a potential next-generation therapy for B-cell-mediated autoimmune diseases.
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Final guidances pouring out of US FDA

Dec. 21, 2023
By Mari Serebrov
With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the development of monoclonal antibodies to treat or prevent COVID-19 to the use of real-world data in drug development.
Read More

Merck’s gefapixant gets second CRL for chronic cough

Dec. 21, 2023
By Karen Carey
Receiving a second complete response letter (CRL) from the U.S. FDA for gefapixant to treat refractory and unexplained chronic cough – an indication for which there are no approved treatments in the U.S., Merck & Co. Inc. said it is reviewing the agency’s feedback to determine the next steps, if any, for the oral selective P2X3 receptor antagonist.
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