CPhI and P-MEC India 2015 to create regional knowledge and business hub
27 November 2015 | By Victoria White
CPhI and P-MEC India will return to the Bombay Convention and Exhibition Centre, Mumbai, India from 1 to 3 December 2015...
List view / Grid view
News
EC gives nod to haemophilia A treatment Elocta
26 November 2015 | By Victoria White
Elocta will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days...
Hikma sells Ben Venue manufacturing facilities to Xellia
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...
EC approves label update for Pfizer’s Xalkori in NSCLC
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...
EC approves anticoagulant reversal agent idarucizumab
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...
Amgen submits Biologices License Application for biosimilar ABP 501 to the FDA
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...
EC approves Cotellic plus Zelboraf in advanced melanoma
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...
FDA approves Portrazza for metastatic squamous NSCLC
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...
Gaucher disease treatment market value to reach $1.16 billion by 2024
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...
EC grants marketing authorisation to Entresto
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).
FDA approves anthrax exposure vaccine BioThrax
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...
Global type 1 diabetes mellitus market value to exceed $7 billion by 2021
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...
EC approves Blincyto for acute lymphoblastic leukaemia
24 November 2015 | By Victoria White
Blincyto is the first bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct approved in European Union...
FDA approves Opdivo for renal cell carcinoma
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...
Merck announces findings from Keytruda combination studies
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...
