Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Pillar Biosciences, Thermedical.
After nearly four decades as director of the U.S. NIH’s National Institute of Allergy and Infectious Diseases (NIAID), 81-year-old Anthony Fauci will be stepping down in December. He also announced Aug. 22 that he will be handing over the reins as chief of the NIAID Laboratory of Immunoregulation and as chief medical adviser to President Joe Biden.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Axsome, Celltrion, Krystal, Kyowa Kirin, Menarini, Stemline, Valneva, Verona, Virfor.
A year from the U.S. FDA’s August 2021 citation of deficiencies in the labeling for Axsome Therapeutics Inc.’s major depressive disorder therapy, Auvelity (dextromethorphan + bupropion), the agency has approved the drug for use by adults. The New York-based company’s stock (NASDAQ:AXSM) took flight on the news, with shares rising 40% to close at $59.55 Aug. 19, surpassing their previous 52-week high of $48.82 and starkly contrasting with a same-period low of $19.38.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astellas, Aum, Biocryst, Curis, Genfleet, Junshi, Novavax, Oncopeptides, Otsuka.
Zavation Medical Products LLC received FDA 510(k) clearance for its Varisync cervical intervertebral body fusion device. Varisync’s plate and spacer components can be used together or paired separately with other components in the company’s cervical spine portfolio. The clearance follows the release Aug. 10 of in vitro and in vivo results of Zavation’s Labyrinth porous interbody device.
It pays to read the details of patent specifications. By keeping the pH range of its generic vasopressin injection at least 0.01 below that specified for Vasostrict, Eagle Pharmaceuticals Inc. cleared itself from claims that it had infringed two key patents protecting the brand drug.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cordx, Zavation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arrowhead, Cybin, Enlivex, GSK, Novavax, Omeros, Organon, Otsuka, Redhill, Samsumg, SK.
An Emergent Biosolutions Inc. facility in Baltimore is under U.S. FDA scrutiny after a February 2022 inspection revealed manufacturing problems, some of which resulted in multiple customer complaints.
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