The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of Biogen’s Alzheimer’s disease medicine Aduhelm (aducanumab), which has a list price of $56,000 per year.
With more than half of the U.S. population fully vaccinated and mask mandates being lifted throughout the country, America looks to resume “normal life” before the pandemic took over.
Med Ad News talked to Wendbush Securities analysts David Nierengarten, Laura Chico, and Liana Moussatos about various new drug approvals and other recent news updates in the industry.
The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.
The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration approved Apellis Pharmaceuticals’ Empaveli as the first targeted C3 therapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
The lack of face-to-face meetings during the Covid-19 pandemic caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals, and a news feature published in Nature Biotechnology suggests these workarounds are here to stay.
BioSpace reviewed the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years.
The U.S. Food and Drug Administration approved Rhythm Pharmaceuticals’ Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing.
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).