Neither product counts as an ‘extended monopoly’ drug under the Inflation Reduction Act, meaning biosimilar entry cannot prevent Medicare from negotiating its price.

Sino acquires Gmax's obesity drug candidate. Simcere partners with Mass General Brigham on select research projects.

CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.

J&J chairman and CEO Joaquin Duato shares striking glimpses of his own life journey at a recent summit as he underscores the value of diversity, equity and inclusion. He also discusses the company’s formulae for innovation and the Kenvue spin out.