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Committee for Medicinal Products for Human Use (CHMP)

CHMP adopts positive opinion of Opdivo in NSCLC and RCC

26 February 2016 | By Victoria White

Both indications are supported by Phase 3 studies in which Opdivo demonstrated a survival benefit versus a standard of care...

CHMP adopts positive opinion of haemophilia B treatment, Alprolix

26 February 2016 | By Victoria White

Alprolix is a recombinant clotting factor therapy developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1...

CHMP adopts positive opinion of Gilead’s Descovy

26 February 2016 | By Victoria White

Descovy is an investigational fixed-dose combination for the treatment of HIV-1 infection in adults and adolescents in combination with other HIV antiretroviral agents...

Empliciti

Empliciti

CHMP adopts positive opinion of Empliciti in multiple myeloma

29 January 2016 | By Victoria White

Empliciti (elotuzumab) is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein...

CHMP issues positive opinion for Tagrisso (osimertinib)

18 December 2015 | By Victoria White

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of AstraZeneca’s Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small…

CHMP issues positive opinion for AstraZeneca’s lesinurad

18 December 2015 | By Victoria White

The CHMP has adopted a positive opinion recommending the marketing authorisation of lesinurad 200mg tablets for the adjunctive treatment of hyperuricaemia in adult gout patients...

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

26 October 2015 | By Victoria White

If approved by the European Commission, Edurant will become available for the treatment of adolescents with HIV-1 for the first time...

CHMP recommends approval of Cosentyx for ankylosing spondylitis and psoriatic arthritis

23 October 2015 | By Victoria White

Cosentyx Phase III studies have consistently demonstrated significant improvements in the signs and symptoms of ankylosing spondylitis and psoriatic arthritis...

CHMP recommends Cotellic and Zelboraf combo in advanced melanoma

25 September 2015 | By Victoria White

The CHMP’s recommendation is based primarily on results of a Phase III study that showed that people who received the combination of Cotellic and Zelboraf lived over a year without their disease worsening...

CHMP adopts positive opinion of Genvoya for HIV-1

25 September 2015 | By Victoria White

The CHMP’s recommendation will now be reviewed by the European Commission. If approved, Genvoya would be Gilead’s first single tablet regimen to contain TAF...

CHMP issues positive opinion for idarucizumab, the reversal agent for dabigatran

25 September 2015 | By Victoria White

Idarucizumab is intended for use in patients treated with dabigatran who require immediate anticoagulant reversal prior to urgent procedures or in case of uncontrolled bleeding...

CHMP adopts positive opinion of azacitidine for elderly patients with AML

25 September 2015 | By Victoria White

The CHMP adopted a positive opinion for an expanded indication of azacitidine for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia who are not eligible for haematopoietic stem cell transplantation...

CHMP recommends heart failure drug Entresto

25 September 2015 | By Victoria White

The CHMP has adopted a positive opinion for Novartis’ Entresto (sacubitril/valsartan), marking an important milestone towards the drug becoming available in the EU.

CHMP grants label extension for GSK’s Synflorix

30 July 2015 | By Victoria White

CHMP has granted a label extension for Synflorix to include protection against IPD caused by pneumococcal serotype 19A in children aged 6 weeks to 5 years...

CHMP adopts positive opinion of Obizur for haemophilia A

28 July 2015 | By Victoria White

The CHMP has adopted a positive opinion for the marketing authorisation of Obizur for the treatment of bleeding episodes in patients with haemophilia...

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