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Medical Devices Regulation: delays and confusion
The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
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European Commission (EC)
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Statement from UK government on EU trade, including pharma industry
A written statement from the UK government has highlighted the importance of trade co-operation with the EU, including for pharmaceuticals.
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EC approves KTE-X19 for treatment of mantle cell lymphoma
KTE-X19, an investigational CAR T-cell therapy, has been granted marketing authorisation by the European Commission.
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Key principles for electronic product information implementation in EU released
The EC, EMA and HMA have published key principles on the various benefits of sharing medicinal product information electronically and how to implement this system.
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EC approves Mayzent® for secondary progressive multiple sclerosis
Mayzent (siponimod) has been approved by the European Commission (EC) for adults with secondary progressive multiple sclerosis (SPMS) based on the results of the EXPAND trial.
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EC approves ustekinumab to treat plaque psoriasis in patients age six to 11
The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
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Spotlight: a dispersible tablet formulation to treat HIV in children
A novel formulation for dolutegravir has been developed to improve HIV treatment options for children. Dr Kimberly Smith from ViiV Healthcare discusses the benefits of this new dispersible tablet.
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European Commission approves Sunosi® (solriamfetol)
EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.
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EC approves Darzalex® in combination with VTd for multiple myeloma
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
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EC approves treatment for severe osteoporosis postmenopausal women
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
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EC approves expanded indication for cystic fibrosis treatment
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
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Generics and biosimilars vital to reduce healthcare costs, finds EC
The EC has released a report that has found generics and biosimilars decrease wasteful spending and maintain health quality in the EU.
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EU marketing authorisation granted for rheumatoid arthritis treatment
Remsima SC™ is the world’s first subcutaneous formulation of infliximab and has been approved in the EU for the treatment of people with rheumatoid arthritis.
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EC approves two new regimens of Keytruda for HNSCC
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
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AML gilteritinib treatment approved by the European Commission
XospataTM (gilteritinib) has been approved as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation.
