London-listed Hikma has signed a second partnership agreement with Arecor, proposing to co-develop a 505(b)(2) hybrid injectable product for the US market.

Hikma has received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.

As the global generics industry had predicted, the unexpected growth seen in the first quarter of 2020 due to forward buying caused by COVID-19 levelled off in the second quarter. However, a few companies managed to report a “mixed” second quarter or a positive first half for 2020, even after experiencing challenges, such as operational interruptions, posed by the pandemic.