PhRMA unveiled a voluntary policy under which drug makers will provide information in DTC ads about how to access drug prices and cost information. But hours later HHS issued a proposed rule on the same topic, only requiring drug makers to include WAC prices in TV ads. .

The company will not commercialize an insulin glargine copy already tentatively approved by FDA as Lusduna, but says it remains committed to biosimilars in oncology and immunology.

Drug price increases have contributed significantly to US revenue growth, about 61% for the 45 largest pharmaceutical products sold over the last three years, according to an analysis by Leerink. Investors should brace for declining growth rates for certain products that generate the bulk of their sales in the US, analyst Geoffrey Porges warned.

Mylan's Kokino spoke with Scrip about what he called the successful launch of the company's first biosimilar in the US, a version of Amgen's Neulasta, the state of the US biosimilar market and resetting expectations.

The company presented encouraging data on functional assessments of four boys treated with a micro-dystrophin gene therapy at the World Muscle Society, furthering momentum around the program.

Hemlibra was approved to prevent or reduce bleeding in adults and children with hemophilia A without factor VIII inhibitors, a significantly larger patient population than its current indication in patients with factor VIII inhibitors.