Drug Development
On Friday, the regulator greenlit Iovance’s lifileucel to treat advanced melanoma. Prior to the approval, experts told BioSpace that tumor-infiltrating lymphocytes therapies also hold the potential to treat several other solid tumors.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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Partners CRISPR and ViaCyte (Vertex), and Genprex are pioneers in the quest to develop a gene therapy for Type 1 diabetes.
The FDA has lifted the clinical hold it had placed on the Phase Ib study following the occurrence of hematological malignancies.
Acadia Pharmaceuticals announced the approval of Daybue (trofinetide) as the first and only drug to treat Rett Syndrome, a rare, neurodegenerative disorder affecting primarily girls.
Despite missing the initial mark, new analysis of Clene’s gold nanocrystal therapy from the HEALEY ALS trial indicates the asset still shows promise.
AstraZeneca reported positive data from both the Phase III ADAURA trial studying Tagrisso (osimertinib) and the Phase III AEGEAN studying Imfinzi (durvalumab) in NSCLC patients.
Data released Wednesday from the Phase III A4 study showed solanezumab fell short of its primary endpoint, failing to slow cognitive decline in patients with preclinical Alzheimer’s disease.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
BioMarin announced Tuesday that the FDA has accepted its supplemental New Drug Application to expand Voxzogo for children younger than five years with achondroplasia.
BridgeBio posted data Monday from its small but highly anticipated Phase II study of infigratinib in achondroplasia - a drug that could give BioMarin a run for its money.
Merck presented Phase IIb data at ACC Monday showing that its hypercholesterolemia hopeful met the primary endpoint.