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Novartis' Sandoz scores EU approval for Remicade biosimilar pharmafile
May 25, 2018
The European Commission has given its approval to Sandoz, Novartis’ generics and biosimilars unit, for its biosimilar version of Janssen’s Remicade (infliximab) and other products, known as Zessly.
EU nod for ViiV/Janssen's two-drug HIV regimen pharmatimes
May 24, 2018
Juluca is comprised of ViiV’s dolutegravir, an integrase strand transfer inhibitor, and Janssen’s rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor.
EU approves Repatha for reduction of CV risk pharmatimes
May 24, 2018
The drug can be used to reduce cardiovascular risk - by lowering low-density lipoprotein cholesterol (LDL-C) levels - as an adjunct to correction of other risk factors.
Free webinar: EU risk management for oncology medicines pharmafile
May 15, 2018
In our latest free webinar, listen to Dr William Richardson, Medical Advisor at NDA Group, speak on how to best implement the revised GVP module (V) concerning risk management in the interests of patients throughout the life-cycle of a medicine.
EU regulators expand reach of Sobi’s Kineret pharmatimes
April 12, 2018
European regulators have expanded the scope of Sobi’s Kineret to include the treatment of Still’s disease, a rare, systemic, multi-organ, auto-inflammatory disorder that affects around 25,000 children and adults in the EU.
EU ready to review Shire’s lanadelumab for HAE pharmatimes
March 30, 2018
EU regulators have validated Shire’s application to market its experimental hereditary angioedema (HAE) drug lanadelumab, indicating that there is sufficient data to begin a priority review.
Six new therapies backed for EU approval pharmatimes
March 27, 2018
Six medicines have taken a big step towards European approval having been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
EU clears first allogeneic stem cell therapy pharmatimes
March 27, 2018
TiGenix and Takeda’s Alofisel has become the first allogeneic stem cell therapy to be approved for use across the European Union.
Industry welcomes progress on Brexit pharmatimes
March 27, 2018
Pharmaceutical industry representatives have applauded the decision to progress Brexit negotiations to the next phase, with the UK and EU having agreed the terms of the transition period.
EU approves AZ’s potential blockbuster hyperkalaemia drug pharmaphorum
March 26, 2018
AstraZeneca’s hyperkalaemia treatment Lokelma has been approved in Europe, a relief to the company after two years of delay to the potential blockbuster.

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