The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.
Back-up generators and secondary manufacturing sites limited the supply and financial impact of Hurricane Maria across J&J’s Puerto Rican pharma facilities, the firm says.
Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.
Around half the products made at the Broomfield facility will be discontinued or divested says Novartis, blaming increased US generics competition and customer consolidation for the closure.
The European Medicines Agency (EMA) has announced it will launch an updated version of information system EudraVigilance to better monitor suspected adverse reactions to medicines.
Cambrex Corporation has announce plans to start making high potency APIs at its plant in Milan, Italy citing impending patent losses for small molecule drugs as an opportunity.
Nestle Health Science has licensed a protein engineering platform from Codexis in a $14m deal that includes an option to co-develop a phenylketonuria drug candidate called CDX-6114.
The EDQM and Anvisa have signed an agreement that may allow drug firms seeking clearance to sell products in Brazil to file CEPs in approval applications.
