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update - Hospira regrets non-compliance

Pfizer unit Hospira and Napp broke APBI code during Remsima push

24-Aug-2016 - Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.

Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial

23-Aug-2016 - Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.

UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

22-Aug-2016 - An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.

Actavis pulls Patheon-made diabetes pills after out-of-spec tests

22-Aug-2016 - Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.

Fast-tracked Factor Xa inhibitor is being made for Portola by CMC Biologics and Lonza

Portola 'surprised' with CMC concerns in FDA rejection of anticoagulant candidate

22-Aug-2016 - Portola Pharmaceuticals says it was "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa.

EMA says biologics developers need to be extra vigilant

19-Aug-2016 - Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.

Roche updating Accu-Chek manual after reports of insulin leaks and under dosing

18-Aug-2016 - Roche is updating instructions for its Accu-Chek insulin pump after patients who failed to load the device correctly experienced hyperglycemic symptoms.

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