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26 November 2015 | By Victoria White
Xellia has said that it plans to invest significantly in the facilities to resume manufacturing in the four sterile injectable manufacturing plants at the site...
26 November 2015 | By Victoria White
The EC has approved a label update to expand the use of Xalkori (crizotinib) to first-line treatment of adults with ALK-positive NSCLC...
26 November 2015 | By Victoria White
Idarucizumab (Praxbind) rapidly and specifically reverses the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery /urgent procedures or in uncontrolled bleeding...
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
25 November 2015 | By Victoria White
The approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening...
25 November 2015 | By Victoria White
The approval is based on the Phase III study where the Portrazza regimen demonstrated a significant improvement in overall survival...
25 November 2015 | By Victoria White
Sales of Gaucher disease therapeutics will rise from $875 million in 2014 to $1.16 billion by 2024, according to research and consulting firm GlobalData...
25 November 2015 | By Victoria White
The European Commission has granted marketing authorisation to Novartis’ Entresto (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
24 November 2015 | By Victoria White
BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible...
24 November 2015 | By Victoria White
GBI Research says this rise will be driven by the uptake of recently approved and pipeline premium products, as well as the rapidly expanding treatment population...
24 November 2015 | By Victoria White
Blincyto is the first bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct approved in European Union...
24 November 2015 | By Victoria White
The announcement marks the approval of the first and only PD-1 inhibitor to deliver significant overall survival in patients with advanced renal cell carcinoma...
23 November 2015 | By Victoria White
The findings come from three studies investigating the use of Keytruda (pembrolizumab) in combination with three other immunotherapies – epacadostat, Imlygic (talimogene laherparepvec), and ipilimumab – in patients with advanced melanoma...
23 November 2015 | By
Genvoya is the first TAF-based regimen to receive marketing authorisation in the EU...
23 November 2015 | By Victoria White
Perrigo will pay AstraZeneca $380 million upon completion of the transaction to acquire the rights to sell Entocort capsules...
