The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).
The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made.
QuVa Pharma has agreed to buy a manufacturing facility in New Jersey, US at which it plans to compound sterile pharmaceutical products for hospitals.
Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler should be suspended.
Teewinot Life Sciences has been granted a US patent for a bioreactor it uses to produce synthetic cannabinoids.
Acquisitions, higher demand for sterile liquid processing and a surge in Thyrosafe orders helped Recipharm offset pricing pressure in Portugal and lower UK sales in Q2.