Latest from Dean Rudge
Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.
After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.
The European Commission’s pending decision for Stada-Bio-Thera could bring a second golimumab biosimilar to market, tightening competition behind Alvotech-Advanz’s early launch plans.
Hikma has initiated a leadership transition, with CEO Riad Mishlawi stepping down after just two years in the role, as margin pressure in its core Injectables business and operational delays weigh on performance.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
“Section viii cannot function as Congress intended,” if a Federal Circuit Court ruling stands, the US solicitor general argued in urging the Supreme Court to review and reverse the closely-watched Hikma Vascepa skinny-label case.
