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EU approval for Sanofi’s type 2 diabetes treatment europeanpharmaceuticalreview
May 08, 2019
Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe
EU approval for Regeneron and Sanofi’s rheumatoid arthritis drug europeanpharmaceuticalreview
May 07, 2019
The European Commission (EC) has granted marketing authorisation for Regeneron and Sanofi’s Kevzara (sarilumab) for the treatment of rheumatoid arthritis…
Holistic approach to data management for pharmaceutical manufacturers europeanpharmaceuticalreview
April 19, 2019
PharmaIntegrity makes it quick and easy to identify and trend cleanroom contamination problems before they occur…
The Falsified Medicines Directive: steps to compliance europeanpharmaceuticalreview
April 19, 2019
As the date of implementing the FMD comes closer, organisations need to be ensuring compliance, whether in the EU or even after a possible no-deal Brexit…
Lynparza gains EU approval for type of metastatic breast cancer pharmatimes
April 11, 2019
AstraZeneca and MSD‘s Lynparza (olaparib) has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer.
First gene therapy recommended for approval in the EU for TDT pharmaceutical-technology
April 03, 2019
US-based therapeutics developer bluebird bio has secured positive recommendation from a European Medicines Agency (EMA) panel for the approval of its first gene therapy Zynteglo to treat certain patients with transfusion-dependent β-thalassemia (TDT).
New lung cancer indication for Keytruda combo OK’d in EU pharmatimes
March 19, 2019
MSD’s anti-PD-1 therapy Keytruda has been approved for use in combination with carboplatin and either paclitaxel or nab-paclitaxel for first-line treatment of adults with metastatic squamous non-small cell lung cancer (NSCLC).
UK prioritises transport of medical products in no-deal Brexit scenario pharmaceutical-technology
March 13, 2019
Despite continued attempts to reach a deal acceptable to Parliament in order for the UK to leave the European Union (EU) with a deal on 29 March, various UK Government departments have listed critical goods that will be considered for transport...
Celgene files for EU approval of ozanimod in relapsing-remitting MS, with US re-submission on track firstwordpharma
March 12, 2019
Celgene on Monday announced the filing of a marketing application in Europe seeking approval of the oral, sphingosine 1-phosphate receptor modulator ozanimod for the treatment of relapsing-remitting multiple sclerosis.
EU steps closer to generics and biosimilars manufacturing waiver pharmaphorum
February 28, 2019
A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer, after lawmakers agreed draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU.

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