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European Commission (EC)

$livtencityTM - First oral treatment approved for post-transplant refractory cytomegalovirus$

First oral treatment approved for post-transplant refractory cytomegalovirus

11 November 2022 | By Catherine Eckford (European Pharmaceutical Review)

The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.

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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)

3 December 2021 | By Anna Begley (European Pharmaceutical Review)

The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.

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CHMP issue positive opinion on Comirnaty^® for five to 11 year olds

1 December 2021 | By Anna Begley (European Pharmaceutical Review)

The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.

Woman sitting in wheelchair in hospital room

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European Commission grants marketing authorisation for Vumerity^®

17 November 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.

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EMA endorses two monoclonal antibody medicines for COVID-19

12 November 2021 | By Anna Begley (European Pharmaceutical Review)

The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.

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Opdivo^® approved in Europe to treat a range of cancers

22 October 2021 | By Anna Begley (European Pharmaceutical Review)

Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.

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EMA’s human medicines committee (CHMP) September meeting highlights

20 September 2021 | By Anna Begley (European Pharmaceutical Review)

In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.

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Kisqali^® demonstrates longest overall median breast cancer survival

20 September 2021 | By Anna Begley (European Pharmaceutical Review)

Kisqali plus letrozole achieved a median overall survival of over five years, the longest ever reported for HR+/HER2 breast cancer.

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J&J’s Ebola vaccine regimen demonstrates immune response

15 September 2021 | By Anna Begley (European Pharmaceutical Review)

Johnson & Johnson’s Ebola vaccine regimen, Zabdeno® and Mvabea®, generated robust humoral immune responses in adults and children.

Man with plaque psoriasis scratching hands

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NICE recommends bimekizumab for severe plaque psoriasis treatment

8 September 2021 | By Anna Begley (European Pharmaceutical Review)

Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.

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EC approves Ultomiris for children and adolescents with PNH

3 September 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).

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BioNTech evaluates mRNA vaccine manufacturing capabilities in Africa

2 September 2021 | By Anna Begley (European Pharmaceutical Review)

BioNTech will evaluate mRNA vaccine manufacturing facilities in Rwanda and Senegal to support vaccine supply in African states.

Photomicrograph of diffuse B-cell lymphoma

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Minjuvi^® receives EC approval to treat large B-cell lymphoma

27 August 2021 | By Anna Begley (European Pharmaceutical Review)

European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.

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JAK inhibitor approved in EU for atopic dermatitis treatment

25 August 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) approved Rinvoq® as the first JAK inhibitor in Europe for the treatment of moderate to severe atopic dermatitis.

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Bimzelx^® receives EC approval for plaque psoriasis treatment

24 August 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) have approved UCB’s Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis.

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European Commission (EC)