The damage at one of Pfizer’s largest injectables facilities could lead to gains for a few Indian companies, analysts feel. However, regulatory risks, litigation pay-outs and other challenges will slow growth for domestic firms and Indian units of multinationals like Abbott and Pfizer in FY24, says rating agency ICRA as Q1 results begin coming in

When weighing accelerated approval, the FDA wants to see that ‘X change in the surrogate translates into Y change in the clinically meaningful outcome,’ Parexel’s Steve Winitsky says. CBER Director Peter Marks opines on the types of therapeutic settings where accelerated approval is best suited, and what happens when a confirmatory trial disappoints.

There are many new pressures on biopharmaceutical profitability but will Merck & Co’s attempt to reverse the drug pricing aspects of the Inflation Reduction Act just divert costs to patients?

Commission issues compulsory orders for information to two organizations that negotiate drug rebates on behalf of CVS Caremark, Express Scripts and other PBMs. It issued similar orders to the six largest PBMs last year.