The European Medicines Agency’s latest list of drugs under review for potential marketing approval includes a second generalized myasthenia gravis treatment from UCB and what could become the first biosimilar version of Stelara in the EU.

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

The antibody-drug conjugate market is emerging as the next battleground for intense competition in China, with global partnerships becoming essential to win, as evidenced by a major new alliance between Innovent and Sanofi.

As the Communist Party of China gears up for its once in every five years National Congress late this fall, the need for more novel drugs to help address the persistent coronavirus pandemic is rising amid the country’s strict “COVID Zero” policies.