Regulatory
In a unanimous 21-0 vote, an FDA advisory committee recommended an updated monovalent formulation of the COVID-19 vaccine targeting the now-dominant XBB.1.5 subvariant.
After an FDA advisory committee unanimously recommended Leqembi’s full approval, questions linger around amyloid-related imaging abnormalities and a potentially cumbersome patient registry.
The FDA has four target action dates this week, including ones for Argenx’s subcutaneous efgartigimod in generalized myasthenia gravis and Sarepta’s gene therapy for Duchenne muscular dystrophy.
Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
Francis deSouza resigned from Illumina’s helm after strong campaigning from activist investor Carl Icahn and the ongoing regulatory roadblocks facing the company’s acquisition of GRAIL.
The Centers for Medicare & Medicaid Services announced Friday it will impose inflation penalties on 43 Medicare Part B drugs in the third quarter of 2023. The action follows fines on 27 drugs in March.
The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
The Federal Trade Commission’s lawsuit takes an unusual strategy, according to legal experts, raising concerns and uncertainties in the biopharma industry.
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