Starting debate: EMA says rules on API materials need clarification
Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.
Archives for October 22, 2014
Actavis takes axe to Forest again, with New York jobs to go
Almost 100 jobs at a commercial packaging facility in New York are set to go as part of Actavis’s continued integration of Forest Laboratories.
Tail-ored to patients: Horizon latest CRO to offer PDX mouse models
Horizon is already making plans for the research model company it acquired last month, announcing today it will offer patient-derived xenograft (PDX) models for breast cancer under the Sage Labs name.
Phøenix from the flåmes? Swedish firm makes the most of old AZ site
A process development firm founded by ex-AstraZeneca employees says closure of the drugmaker’s Swedish R&D site gave it technical knowhow and former colleagues as customers.
GSK £1bn savings plan to hit manufacture towards 2017, but UK likely immune
GlaxoSmithKline plans to cut manufacturing, sales and R&D as part of a three year plan to save £1bn ($1.6bn) annually.
EMA launches rolling review process for Ebola vaccine makers
Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.