US FDA slams Korean OTC maker: All employees ‘lack knowledge of GMP requirements’
The US regulator has issued Barox a warning letter citing labelling, storage and quarantine violations in Seongnam, South Korea.
Archives for December 10, 2018
Akorn CEO resigns after Fresenius merger collapses
The Supreme Court ruled that Fresenius was within its rights to terminate the merger agreement with Akorn.
Sandoz’ EpiPen rival will launch in Q1, with lower price tag
Sandoz will launch its epinephrine generic in early 2019 at a lower price point than rival generics on the market.
Trianni licenses humanized model platform to MacroGenics for oncology research
Trianni to provide MacroGenics with humanized mouse model platform for its mAb therapeutics research.
Clinerion adds 1.2m patients to network in Brazil
Clinerion and Santa Casa da Misericordia hospital are partnering to bring clinical trial opportunities to patients and diverse data to CROs and sponsors.
Simpler drug delivery through capsule-based inhalation
Delivery by inhalation could be an easier way to deliver therapies in areas such as oncology, suggested ACG’s development manager.
Parexel and Eli Lilly team up to develop clinical researcher pool in China
Parexel and Eli Lilly are launching a clinical research learning and development program in China as recent reforms have “dramatically” increased the need for new sites in the country.