The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
Novartis joined industry associations in expressing concerns over the impact that a ‘hard’ or ‘disorderly’ Brexit could have on the life sciences sector.
The EMA announces further details on its move from current London headquarters to Amsterdam, which will begin on March 1 and see staff working in its new offices on March 11.
MedPharm expands its US Center of Excellence in Durham, North Carolina, in response to increasing demand for its topical and transdermal formulation development, and performance testing services.
Takeda’s aim to acquire Shire for $62bn received a boost after regulators vote positively to approve the transaction following the divestment of Shire’s IBD drug.
Vertex was granted marketing authorization for its cystic fibrosis therapy in a combination regimen, marking the company’s third treatment for the condition to reach the market.
ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.
The European Medicines Agency has unearthed a ‘sartan’ medication, in losartan, that contains low levels of the carcinogenic substance, N-nitrosodiethylamine.
Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.