Ohio facility sees new life as Xellia moves production from North Carolina
Xellia will move US production from its North Carolina manufacturing facility to its site in Ohio to bolster workforce and manufacture generic IV antibiotics.
Archives for July 2, 2019
Strides receives FDA warning letter and defers 10 ANDAs
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
Trinity sets up flagship office in Europe led by former Syneos manager
The strategic advisory company, Trinity, opens a new office in Germany, with leadership joining from Syneos Health to work “hand-in-hand” with biopharma clients.
Innovative Trials enters partnership to complete trial recruitment and retention
Innovative Trials will work with an undisclosed global pharmaceutical company to speed up patient recruitment for clinical trials using its proactive site optimization service.
Iqvia leads $14m investment round in patient engagement app
Belong.Life raises $14m as part of a Series B funding round with plans to expand its patient engagement platform, using and complementing Iqvia’s solutions “to transform patient engagement,” says Iqvia VP.
Amicus picks Brammer for preclinical, clinical gene therapy work
Rare disease drug developer to work with Brammer Bio – which Thermo Fisher acquired in March – on gene therapy programs against Batten disease.
DIA 2019
‘Nothing about me, without me’: DIA panel addresses patient data and the future of research
Panelist during the opening session of the DIA Annual Meeting last week stressed the need to work collaboratively, bringing patients into the fold as co-creators of clinical trials to ‘create a whole new landscape for research.’
FDA-EMA mutual recognition: Germany in, one country left
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.