CHMP adopts positive opinion of Obizur for haemophilia A
28 July 2015 | By Victoria White
The CHMP has adopted a positive opinion for the marketing authorisation of Obizur for the treatment of bleeding episodes in patients with haemophilia...
List view / Grid view
News
Allergan to acquire Naurex; divests generics business to Teva
27 July 2015 | By Victoria White
Allergan followed an announcement it made yesterday about its acquisition of Naurex with news today that it is to divest its generics business to Teva...
EMA grants accelerated assessment of MAA for Empliciti
27 July 2015 | By Victoria White
The EMA validated for review the Marketing Authorisation Application (MAA) for Empliciti for the treatment of multiple myeloma...
Four-channel HPLC increases clinical throughput capabilities with Class I medical device listing
Clinical laboratories requiring high-throughput separations for their LC-MS assays now have access to a new four-channel, high-performance liquid chromatography (HPLC) system designed to increase the productivity and efficiency of clinical sample separations, while freeing valuable bench space.
FDA approves Technivie for GT4 chronic HCV
27 July 2015 | By Victoria White
The US FDA has approved AbbVie’s Technivie in combination with ribavirin for the treatment of adults with genotype 4 chronic hepatitis C virus infection...
EMA grants accelerated assessment to ixazomib
27 July 2015 | By Victoria White
The CHMP of the EMA has granted an accelerated assessment to ixazomib for the treatment of patients with relapsed and/or refractory multiple myeloma...
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...
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).
