Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Aridis, Ascentage, Cocrystal, IGM, Pepgen, Pharmazz, Precigen, Rocket.
Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GE Healthcare, Think Surgical.
In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.
The U.S. FDA has granted 510(k) clearance to GE Healthcare Technologies Inc. for its Precision DL for PET/CT, an artificial intelligence (AI) and deep learning (DL)-powered software designed to sharpen quality and improve efficiencies in medical imaging. Part of the company’s Effortless Recon DL portfolio, the technology is available on GE’s Omni Legend PET/CT digital scanner.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Amylyx, Beigene, Bristol Myers Squibb, Inhibrx, Iovance, Janssen, Lexicon, Metriopharm, SK, Valneva.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABK Biomedical, Blue Earth, Cepheid, Concept Medical, Establishment Labs, Pulse Medical, Quantalx.
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish.
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report.
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