The third quarter could bring US approvals for a range of novel drugs, including the first treatment for a common eye disease, the first US approval of PD-1/L1 inhibitor from a Chinese firm, and the first oral therapy for postpartum depression.
PDUFA for NDA - Second Review 24 July
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The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.
Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The company announced positive topline results for the oral GLP-1 drug in type 2 diabetes that beat expectations.
BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.
Recent moves in the industry include C-suite changes at Merck KGaA, Newleos Therapeutics and Artiva Biotherapeutics, plus Valo Therapeutics acquires chief executive officer from Johnson & Johnson.
