Access to yeast strains modified to produce opiates must be controlled say researchers who warn that stopping criminals using such API manufacturing routes to make narcotics is vital.
US Senator Bernie Sanders has called on the Secretary of Veteran Affairs to invoke a law which would break Gilead’s patent on Hepatitis C drug Sovaldi and allow cheaper generics.
EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.
Despite pharma being “highly regulated and slow to change,” continuous manufacturing will soon be realised, says Rutgers University which has received an R&D grant from J&J.
The EMA has released guidelines on developing combination drugs with more than one active pharmaceutical ingredient (API).