Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Cvrx, Sofwave Medical.
Senti Biosciences Inc. has received clearance of its IND application from the FDA for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33- and/or FLT3-expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndrome, while sparing healthy bone marrow cells.
Olix Pharmaceuticals Inc. has received approval from the Alfred Human Research Ethics Committee (HREC) in Australia to conduct a phase I clinical trial of drug candidate OLX-75016 for the treatment of nonalcoholic steatohepatitis (NASH).
Asieris Pharmaceuticals Co. Ltd. announced that it has received approval to commence phase I clinical trials in Australia of its novel antibacterial drug, APL-2301 (ASN-1733, MET-102), under development for the treatment of Acinetobacter baumannii infections.
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.
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.
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.
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.
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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