The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.
ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.
Sun Pharmaceutical Industries has declined to comment on reports it is to sell its US manufacturing business Ohm Laboratories.
Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.
ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.
Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of GDP guidelines.
MilliporeSigma has opened a facility in Spain dedicated to the manufacture of the solubility-enhancing excipient meglumine.