George Badescu, chief business officer at Heidelberg Pharma, discusses antibody-drug conjugate development, partnership styles and the appetite for risk-taking in the biopharma industry.

Lupin’s CEO highlights market access strategy as a key tool to ensure biosimilars success in the US while being relieved the company didn’t launch a Humira biosimilar. She also mentions Amazon and Mark Cuban have not upset market dynamics for generics in the US and a Lucentis biosimilar is closer to a global launch post Phase III trial success

The US FDA’s Genetic Metabolic Diseases Advisory Committee will comprise three regular voting members and 13 temporary members, including some adcomm veterans, when it reviews Zevra Denmark’s arimoclomol for Niemann-Pick disease type C.

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.