AbbVie’s Viekirax approved as HCV treatment in Japan
28 September 2015 | By Victoria White
The approval provides a new interferon and ribavirin-free treatment option for patients with most common type of hepatitis in Japan...
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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 recommends Elocta for haemophilia A
25 September 2015 | By Victoria White
Elocta is a recombinant factor VIII Fc fusion protein product that, if approved, would be the first haemophilia A treatment with prolonged circulation available in the EU...
Novo Nordisk completes second Phase 3a trial with semaglutide
25 September 2015 | By Victoria White
The trial investigated the efficacy and safety of semaglutide compared with exenatide in 813 people with type 2 diabetes...
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.
What is a biosimilar medicine? NHS England explains all in new publication
25 September 2015 | By Victoria White
The British Generic Manufacturers Association, the Association of the British Pharmaceutical Industry (ABPI), and the UK BioIndustry Association (BIA) have joined forces to welcome NHS England’s new publication “What is a biosimilar medicine?”.
Yusen Logistics opens Global Pharma Airfreight Gateway at Amsterdam Schiphol
The official opening ceremony was performed by Mr Hiromitsu Kuramoto, President of Yusen Logistics. Mr. Kuramoto joined with Yusen Logistics colleagues in welcoming guests including customers, Airport officials and Customs authorities at the inauguration event.
CHMP recommends mepolizumab for severe refractory eosinophilic asthma
24 September 2015 | By Victoria White
Mepolizumab is an anti-IL 5 monoclonal antibody that is delivered in a 100mg dose via subcutaneous injection every four weeks...
Sayana Press becomes first contraceptive in the UK for self-injection
24 September 2015 | By Victoria White
Sayana Press combines a long-acting, reversible, contraceptive with an all-in-one prefilled, single-use, non-reusable Uniject injection system...
EC approves Fexeric for the treatment of hyperphosphatemia
24 September 2015 | By Victoria White
Fexeric is approved for the control of elevated serum phosphorus levels in adults with chronic kidney disease, including both dialysis and pre-dialysis patients...
Novo Nordisk to build new manufacturing plant in Iran
24 September 2015 | By
The project is expected to last five years and represents a Novo Nordisk investment of approximately 70 million euros...
NICE recommends idelalisib for chronic lymphocytic leukaemia
24 September 2015 | By Victoria White
Idelalisib has been recommended in combination with rituximab for adults with chronic lymphocytic leukaemia (CLL) who have relapsed early...
