US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant
The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.
Archives for May 23, 2017
Eye drops to replace painful injections in AMD patients
The University of Birmingham has developed a cell-penetrating peptide it claims could be used to make eye drop versions of age-related macular degeneration drugs currently delivered by injection.
PPD expands Virginia vaccine lab with an eye on assays
Pharmaceutical Product Development LLC (PPD) has expanded its vaccine research services lab in Richmond, Virginia.
CDMO Recro expands manufacturing capabilities at former Alkermes site
Recro has added a new tablet manufacturing suite that enables it to compress single- and bi-layer tablets at commercial speeds.
Granules India confirms $35m US plant expansion will create jobs
Granules India says adding manufacturing capacity at its facility in Virginia, US will create 102 jobs.
CROS NT extends Medidata partnership
The extended partnership provides CROS NT customers access to Medidata’s electronic data capture (EDC) solution as well as its randomization and trial supply management system (RTSM).
US ban for Changzhou Jintan Qianyao raises questions about customers says expert
The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”
update
Ashfield acquires contract sales organization, UDG raises FY guidance
Ashfield has acquired the German and Swiss contract sales outsourcing business Sellxpert for a reported $14.4m.