CHMP recommends Revolade for severe aplastic anaemia
27 July 2015 | By Victoria White
CHMP has adopted a positive opinion for Revolade for the treatment of patients with severe aplastic anaemia who have had an insufficient response to IST...
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CPhI Korea opens as South Korea emerges as global leader in biosimilar trials
27 July 2015 | By Victoria White
CPhI Korea, organised by UBM EMEA, will return to the COEX in Seoul, South Korea – 7 to 9 September 2015 – following a successful inaugural event last year...
CHMP recommends approval of isavuconazole in the EU
27 July 2015 | By Victoria White
CHMP has adopted a positive opinion recommending the approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis...
Coulter Partners strengthens its research capability with two new appointments
27 July 2015 | By Coulter Partners
Global Life Sciences search specialist, Coulter Partners is pleased to announce the appointments of Emma Hiom as Principal and Zubair Yusuf as Senior Associate in the UK...
FDA approves Daklinza for the treatment of HCV genotype 3
27 July 2015 | By Victoria White
Daklinza has been approved by the US FDA, marking the first time patients with chronic HCV genotype 3 have a 12-week, once-daily, all-oral treatment option...
Tafinlar and Mekinist combination therapy achieves regulatory milestones
27 July 2015 | By Victoria White
The CHMP has adopted a positive opinion for the combination of Tafinlar and Mekinist for the treatment of adult patients with advanced melanoma...
Keryx’s hyperphosphatemia treatment Fexeric backed for European approval
24 July 2015 | By Victoria White
The CHMP has adopted a positive opinion for on marketing authorisation of Fexeric, recommending its approval for the treatment of hyperphosphatemia in CKD...
MHRA concludes stroke drug alteplase is safe and effective
24 July 2015 | By Victoria White
An independent expert review of alteplase has provided a firm reassurance that it is safe and effective for use up to 4.5 hours after the onset of symptoms...
Regorafenib now available on NHS Wales for treatment of advanced GIST
24 July 2015 | By Victoria White
Regorafenib has been recommended for use on NHS Wales as a third-line treatment for patients with advanced gastrointestinal stromal tumours (GIST).
CHMP adopts positive scientific opinion of malaria vaccine Mosquirix
24 July 2015 | By Victoria White
The CHMP has adopted a positive scientific opinion for Mosquirix, making it the first vaccine for the prevention of malaria to reach such a milestone...
Shire receives CHMP positive opinion for ADHD drug Intuniv
24 July 2015 | By Victoria White
The CHMP has adopted a positive opinion recommending the approval of Shire’s Intuniv for the treatment of ADHD in children and adolescents...
Aromatase inhibitors substantially reduce breast cancer deaths
24 July 2015 | By Victoria White
A study of more than 30,000 women shows that aromatase inhibitors substantially reduce the risk of death in postmenopausal women ER-positive breast cancer...
Type 2 diabetes mellitus treatment market value will reach $39b by 2021
23 July 2015 | By Victoria White
The global market for type 2 diabetes mellitus therapeutics will rise in value from $23.5 billion in 2014 to an estimated $39 billion by 2021, driven primarily by rising disease prevalence and the continued uptake of recently approved and emerging branded treatments, according to business intelligence provider GBI Research.
Amgen submits sNDA for Kyprolis in relapsed multiple myeloma
23 July 2015 | By Victoria White
Amgen has submitted a sNDA to the US FDA for Kyprolis to seek an expanded indication for the treatment of patients with relapsed multiple myeloma...
EMA validates two Opdivo indication extension applications
23 July 2015 | By Victoria White
The EMA has validated two type II variation applications which seek to extend the indication of Opdivo in non-squamous NSCLC and advanced melanoma...
