Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.
Despite imperfect data and the use of post hoc analyses to overcome a failed endpoint, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 June 28 that Ipsen SA’s ultra-rare bone disease drug, palovarotene, demonstrated efficacy in treating patients with fibrodysplasia ossificans progressiva (FOP).
South Korea’s JW Pharmaceutical Corp. announced a redo of its IND application to the Taiwan FDA on June 27 for its phase III trial on gout treatment URC-102 (epaminurad). The second filing comes in response to a regulatory rejection in March citing a problem with the proposed reference drug.
Opko Health Inc. stands to receive a $90 million milestone payment from partner Pfizer Inc. on the U.S. FDA approval of once-weekly human growth hormone analogue Ngenla (somatrogon) for pediatric patients with growth hormone deficiency. Pfizer expects to make the drug available to patients starting in August 2023.
With the biggest biosimilar launch in the U.S. just days away, Humira’s (adalimumab) record-breaking ride is quickly slowing down, but the Abbvie Inc. mega-blockbuster immunology drug is nowhere near the end of its road. Meanwhile, the U.S. journey is just beginning for the eight adalimumab biosimilars that could come to market as early as July 1 through licensing agreements with Abbvie. Besides revving their engines against Humira, the new launches will be looking to overtake Amgen Inc.’s biosimilar, Amjevita, which got a five-month headstart in the U.S., thanks to the first-mover status Amgen earned for being the first to sign a licensing agreement with Abbvie.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kalos Medical.
Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease that are not on dialysis.
The World Health Organization (WHO) recently gave an emergency use listing for SK Bioscience Ltd.’s COVID-19 vaccine called Skycovione, a self-assembled nanoparticle vaccine that targets the SARS-CoV-2 spike protein.
After nearly 10 years in clinical development and just a few months after an EMA rejection, Ipsen SA will be making its case June 28 before a U.S. FDA advisory committee for its ultra-rare bone disease drug, palovarotene.
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