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European Commission (EC)

Key principles for electronic product information implementation in EU released

30 January 2020 | By Hannah Balfour (European Pharmaceutical Review)

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.

image of a brain and neurons, one with healthy myelin and the other with damaged myelin

news

EC approves Mayzent^® for secondary progressive multiple sclerosis

29 January 2020 | By Hannah Balfour (European Pharmaceutical Review)

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.

news

EC approves ustekinumab to treat plaque psoriasis in patients age six to 11

28 January 2020 | By Victoria Rees (European Pharmaceutical Review)

The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.

article

Spotlight: a dispersible tablet formulation to treat HIV in children

27 January 2020 | By Victoria Rees (European Pharmaceutical Review)

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.

news

European Commission approves Sunosi^® (solriamfetol)

23 January 2020 | By Rachael Harper (European Pharmaceutical Review)

EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.

computer model image of daratumumab's enzyme target

news

EC approves Darzalex^® in combination with VTd for multiple myeloma

22 January 2020 | By Hannah Balfour (European Pharmaceutical Review)

The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.

news

EC approves treatment for severe osteoporosis postmenopausal women

13 December 2019 | By Victoria Rees (European Pharmaceutical Review)

Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.

news

EC approves expanded indication for cystic fibrosis treatment

11 December 2019 | By Hannah Balfour (European Pharmaceutical Review)

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.

news

Generics and biosimilars vital to reduce healthcare costs, finds EC

29 November 2019 | By Victoria Rees (European Pharmaceutical Review)

The EC has released a report that has found generics and biosimilars decrease wasteful spending and maintain health quality in the EU.

news

EU marketing authorisation granted for rheumatoid arthritis treatment

27 November 2019 | By Rachael Harper (European Pharmaceutical Review)

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.

news

EC approves two new regimens of Keytruda for HNSCC

21 November 2019 | By Victoria Rees (European Pharmaceutical Review)

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.

news

AML gilteritinib treatment approved by the European Commission

28 October 2019 | By Rachael Harper (European Pharmaceutical Review)

XospataTM (gilteritinib) has been approved as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation.

news

EPIDYOLEX^® receives marketing authorisation in Europe

23 September 2019 | By Victoria Rees (European Pharmaceutical Review)

The cannabidiol-based treatment EPIDYOLEX has been granted marketing authorisation from the European Commission.

news

EC approves expanded use of ustekinumab for ulcerative colitis

6 September 2019 | By Victoria Rees (European Pharmaceutical Review)

The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.

news

Terrosa^® osteoporosis biosimilar treatment launched in Europe

21 August 2019 | By Victoria Rees (European Pharmaceutical Review)

A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.

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