Regulatory
Although the FDA did not outright say there is a causal secondary malignancy relationship, it asked BMS, Gilead, J&J and Novartis to add warnings to the labels of six CAR-T therapies noting the potential risks.
As with any new year, 2024 presents new possibilities; though new and existing challenges are also poised to shape its trajectory. BioSpace reflects on the recent JP Morgan Healthcare Conference and future outlook with key opinion leaders who share their thoughts on the economic climate.
Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
CBER Director Peter Marks recently spoke in favor of single-arm trials in certain situations, but clinicians and ethicists say there are several variables to consider.
Regulatory authorities worldwide are tightening their monitoring mechanisms and launching their own investigations after reports of secondary malignancies potentially linked to chimeric antigen receptor T cell therapies.
The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.
After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.
The agency nevertheless said that it could not definitively rule out a small risk of suicidal ideation associated with GLP-1 receptor agonists, and that it will continue evaluating the evidence.
Biologics have a major advantage over small molecule drugs under the Inflation Reduction Act’s provisions, according to stakeholders attending this week’s J.P. Morgan conference.
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