South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.
In response to the UK government’s publication of potential ramifications of a no-deal Brexit, the ABPI responded that the pharma industry needs more details on mitigation strategies.
The global CRO Cromsource has opened a new office in Research Triangle Park – home to many current and potential clients – after growing more than 150% over the two years, says COO.
Catalent to invest $9m in the building of an early-stage clinical supply facility in San Diego, due to open in the summer of 2020, to integrate its CDMO business.
The acquisition of Bioclinica’s clinical research site business extends PPD’s trial enrollment business to five continents, 20 countries, and more than 180 research sites.
Strides acquires the only FDA-approved integrated soft gel capsule manufacturing facility in the US, owned by Micelle, to support its operations in India.
The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
