Adalvo, the B2B unit of the Alvo group of companies, has announced a successful decentralized European approval for its pregabalin prolonged-release tablets, with a launch imminent. The “milestone” for its value added medicines program could allow the firm to offer what it has previously billed as “the first once-daily pregabalin formulation.”

The Inflation Reduction Act should take a different approach when it comes to authorized generic products, Sandoz US chief commercial officer Tim DeGavre has told Generics Bulletin.

The EMBARK trial’s availability to more patients likely contributed to the much quicker enrollment than confirmatory trials for Exondys 51, Vyondys 53 and Amondys 45, which also saw enrollment targets and eligibility ages change over the years.

The Duchenne muscular dystrophy candidate should be approved because it will help grow development in the space, patient groups argue, not just because of the value the gene therapy could provide to those receiving the treatment itself.