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Regulatory
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Regulatory actions for Feb. 3, 2023

Feb. 3, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Calliditas, GSK, Pfizer, Pharmather, Pliant, Y-mabs.
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Kidney, pills, bottle

GSK’s daprodustat cleared as first FDA-approved oral HIF-PHI in CKD-related anemia

Feb. 2, 2023
By Jennifer Boggs
Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established.
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Close-up of eye with digital focus

Human factors engineering a requirement for software used with cameras for vital signs

Feb. 2, 2023
By Mark McCarty
The U.S. FDA recently posted the regulation for software used to derive vital signs from optical camera images thanks to a successful de novo petition by Oxford, U.K.-based Oxehealth Ltd., a regulation that carries the usual requirements for software verification and validation. However, the regulation also requires some human factors engineering (HFE) studies of the software interface, a requirement that may become more demanding to fulfill per a recent draft guidance on the subject.
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FTC’s energy labeling rule draws fire from MITA over servicing provisions

Feb. 2, 2023
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has once again waded into the question of whether medical devices should be included in the agency’s right-to-repair discussion, most recently in an advanced notice of proposed rulemaking ostensibly titled for energy labeling. The Medical Imaging & Technology Alliance (MITA) pushed back on the proposal by pointing to the draft’s required disclosure of proprietary information about a medical device system, a provision MITA said might detract from patient safety.
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WTO logo

Decision to expand WTO COVID-19 waiver drags on as pandemic wanes

Feb. 2, 2023
By Mari Serebrov
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
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Bcht Biotech gains China’s first approval for domestic zoster vaccine

Feb. 2, 2023
By Doris Yu
Changchun Bcht Biotechnology Co. Ltd. has obtained marketing approval for its live attenuated zoster vaccine in China, making it the first approved shingles vaccine developed by a Chinese company. An injectable of 0.5 ml per dose, it is designed for adults ages 40 and older and will go up against GSK plc’s Shingrix vaccine.
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Regulatory actions for Feb. 2, 2023

Feb. 2, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aspivix, Qvin, Reflexion Medical.
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Regulatory actions for Feb. 2, 2023

Feb. 2, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agile, Artiva, Beactica, Edesa, Ellipses, Flag, Genoscience, Greenlight, Mesoblast, ONL, Roche, Taysha, Xortx.
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FDA hammers Righteye for off-label promotion of visual impairment system

Feb. 1, 2023
By Mark McCarty
The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease.
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Future of US biosimilar pipeline could rest on Humira competition

Feb. 1, 2023
By Mari Serebrov
A lot of biosimilar sponsors and wannabes will be watching as the Humira biosimilar competition unfolds in the U.S. While the competition started Jan. 31 with the launch of Amgen Inc.’s Amjevita, the true test of the strength of the competition will come in five months when other adalimumab biosimilars, including Boehringer Ingelheim GmbH’s interchangeable, hit the market.
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