Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Alpha, Eisai, Escient, Huidagene, Junshi, Moderna, Nanoscope, Novelmed, Regeneron, Sandoz, Sanofi, Xeris, Zai.
The U.S. FDA has posted or updated several recalls in the second half of January 2023, such as the class I recall of Mahurkar hemodialysis catheters distributed by Medtronic plc., reported Jan. 30. This recall is associated with two injuries but no fatalities to date, but the potential for mixing of venous and arterial blood has forced Medtronic to request that its customers quarantine any unused catheter kits, which could be a substantial amount of product given the nearly 23,000 units are affected by the recall.
The advantage of the U.S. FDA’s effort to regulate artificial intelligence (AI) in medical devices is that it is specific to medical devices and other medical products, but this vertical approach to AI regulation might soon become exceptionally complicated thanks to a new AI risk management framework posted by the U.S. National Institute for Standards and Technology (NIST). The NIST guideline is agnostic to the sector of the economy and thus may carry with it the expectation that developers of software as a medical device will hew to both the NIST framework and FDA regulations, a layering of requirements that could vastly complicate the task of developing and deploying these algorithms.
A Jan. 27 settlement the U.S. SEC reached with a former vice president at a biotech company serves as a reminder that insider trading rules applies to suppliers as well as the companies involved in an M&A.
Taking aim at big pharma’s current penchant for acquisition over in-house innovation, Sen. Elizabeth Warren (D-Mass.) is asking the Federal Trade Commission (FTC) to consider the impact a biopharma merger, whether it’s proposed or a done deal, may have on future innovation.
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib, for patients with tenosynovial giant cell tumors who are not able to have surgery.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health.
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