US FDA wants to reclassify co-crystals to ease regulatory burden
The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
Archives for August 17, 2016
Fresenius Kabi set for tax breaks after commiting to invest $250m in US plant
Fresenius Kabi has said it will increase manufacturing capacity and create jobs at a site in Illinois in a move that will earn the German firm US tax breaks.
Evolva to apply yeast-based production tech to APIs for US biotech partner
Evolva has agreed to develop new ways of making APIs for an unnamed US biotech using its fermentation system.
Roche updating Accu-Chek manual after reports of insulin leaks and under dosing
Roche is updating instructions for its Accu-Chek insulin pump after patients who failed to load the device correctly experienced hyperglycemic symptoms as a result of under dosing.
Piramal: $53m Ash Stevens addition ‘synergistic’ with ADC business
The acquisition of Ash Stevens and a US high potent API facility will bolster Piramal’s antibody-drug conjugate offerings, the Indian CDMO says.