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Pharming Group NV’s stock skyrocketed March 24 on news that the U.S. FDA approved Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS) for those ages 12 and older. The nod, which came a few days ahead of the March 29 PDUFA date, sent shares (NASDAQ:PHAR) up 33%, or $3.69, to end the day at $14.96.
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neurorpm, Syntheticmr.
Incyte Corp.’s bid for a once-daily vs. twice-daily version of the Janus kinase inhibitor Jakafi (ruxolitinib) was foiled, at least temporarily, by a complete response letter (CRL) from the U.S. FDA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Aurion, Biogen, Cidara, Creative Medical Technology, Dyne, Incyte, Kite, Melinta, Olix, Ono.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Echosens, Tela Bio.
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
Tofersen’s development is progressing in fits and starts. That was evident at the U.S. FDA’s March 22 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, which unanimously agreed Biogen Inc.’s failed phase III study predicted a clinical benefit in treating amyotophic lateral sclerosis (ALS) that includes the rare superoxide dismutase 1 component.
Incyte Corp.’s retifanlimab-dlwr received its first regulatory nod on March 22, with the U.S. FDA granting accelerated approval for the PD-1 inhibitor to treat adults with a rare form of skin cancer, advanced Merkel cell carcinoma.
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