Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Aprea, Immvira, Polpharma, Spectrum.
A three-month delay proved to be of no concern for Nexviazyme (avalglucosidase alfa-ngpt, neoGAA), Sanofi SA’s long-term enzyme replacement therapy (ERT), which gained FDA approval for intravenous infusion to treat patients 1 and older with late-onset Pompe disease.
TORONTO – Health Canada has green-lighted an all-in-one virtual reality (VR) platform for use in diagnostic radiology. Software developer Luxsonic Technologies Inc. said the award of a class II medical device license to its mobile Sievrt suite of diagnostic tools is the first time a VR system of this kind has been approved by a national regulatory agency.
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.
Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL). The company is seeking more approvals for nasopharyngeal and lung cancers in both China and the U.S. to stand out in the increasingly competitive PD-1 space.
Manufacturing deficiencies were cited in the FDA’s complete response letter (CRL) for Spectrum Pharmaceuticals Inc.’s Rolontis (eflapegrastim), a decision that will further delay to market in the U.S. what could be the *first novel G-CSF drug in more than 15 years to treat chemotherapy-induced neutropenia.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Certest Biotech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, China Pharma, Eiger, Everest, Exelixis, Merck, Therapeutic Solutions.
Canada’s Federal Court of Appeal took the Patented Medicine Prices Review Board to task for ordering Alexion Pharmaceuticals Inc. to “forfeit excess revenues” generated by Soliris (eculizumab) between 2009 and 2017.
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