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8 April 2016 | By Victoria White, Digital Content Producer
The CHMP has recommended approval of a type II variation to include data from the TERRAIN trial of Xtandi (enzalutamide) versus bicalutamide...
5 April 2016 | By Victoria White
This recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared...
5 April 2016 | By Victoria White
If approved, this 3‑monthly injection will allow patients to maintain an optimal level of treatment in their blood with fewer administrations...
5 April 2016 | By Victoria White
The European Medicines Agency’s CHMP has adopted a positive opinion for a licence extension for Eisai’s Halaven (eribulin)...
29 February 2016 | By Victoria White
The CHMP positive opinion is based on the results of the head-to-head LUX-Lung 8 trial in patients with SqCC...
26 February 2016 | By Victoria White
The CHMP opinion of the Type-II variation application for Viekirax + Exviera is supported by data from the Phase 3b TURQUOISE-III study...
26 February 2016 | By Victoria White
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with IL-17A cytokine and inhibits its interaction with the IL-17 receptor...
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...
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...
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...
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...
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…
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...
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...
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...
