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Home » Topics » Regulatory

Regulatory
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One trial, two regulators, two opinions on Oncopeptides drug

Sep. 14, 2023
By Mari Serebrov
Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market.
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Onpattro

Alnylam posts an adcom win but shares slide

Sep. 14, 2023
By Lee Landenberger
A U.S. FDA advisory committee’s backing keeps Alnylam Pharmaceuticals Inc.’s Onpattro (patisiran) on the road to a supplemental approval in treating a rare heart disease, but it couldn’t stop the company stock from sliding. Shares (NASDAQ:ALNY) closed Sept. 14 down 8.8% at $193.06, the day after the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 that patisiran’s benefits outweigh the risks in treating cardiomyopathy of transthyretin-mediated amyloidosis.
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Regulatory actions for Sept. 14, 2023

Sep. 14, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Aston, Bioray, Madrigal, Moderna, Morphosys, Nurexone, Rocket, Takeda.
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Regulatory actions for Sept. 14, 2023

Sep. 14, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Attune Medical, Beacon Biosignals, Venus Concept.
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China’s NMPA issues revised guidance for med tech risk-benefit assessment

Sep. 14, 2023
By Mark McCarty

China’s National Medical Products Administration (NMPA) has largely completed its development of overarching regulations for medical devices and is now drilling down into more granular matter, such as a guidance on assessments of benefits and risks for medical devices. Grace Fu Palma, CEO of China Med Device LLC, told BioWorld that this new guidance is a much more detailed version of the 2019 edition, but added that China’s anticorruption efforts will be ramped up with an eye toward health care, just one of several current and impending developments of interest in this massive market.


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Test tube, dropper

‘Comfort blanket’ of biosimilar efficacy studies still needed?

Sep. 13, 2023
By Mari Serebrov
To streamline the development of biosimilars and align it with current analytical science, regulators across the globe are reevaluating a routine requirement for comparative clinical efficacy studies for biosimilar candidates.
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Regulatory actions for Sept. 13, 2023

Sep. 13, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Arcutis, Biontech, Cygenica, Eikon, Gain, Hoth, Moderna, Pfizer.
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Regulatory actions for Sept. 13, 2023

Sep. 13, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annalise.ai, Corvista.
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TGA de-lists STAR ankle device due to high rates of device fracture

Sep. 13, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
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Updated COVID-19 vaccines likely to hit US market in day or two

Sep. 12, 2023
By Mari Serebrov
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
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