Catalent contract secure as Roche buys InterMune for $8.3bn
Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).
Archives for August 24, 2014
PSC to enter US injectables space with new CMO at former PurTox site
PSC Biotech plans to enter the US sterile injectables contracting space after buying a plant originally set up by J&J unit Mentor Biologics to make a Botox rival.
ICH plans new guidance on multi-regional clinical trials
As the US FDA, EMA and Japan’s PMDA have released guidelines and related position papers on multi-regional clinical trials, the ICH is now proposing to do the same but with a more multi-national approach.
EFPIA, EGA take issue with EMA’s guidance on stability data for APIs
EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes.
Argentina to allow Indian drug imports after inspecting five plants
Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
Planning essential to ensure temperature control, say logistic firms
Temperature fluctuations during shipping have led to costly clinical data delays and product recalls, but such problems can be avoided through supply chain pre-planning say distribution firms.