FDA grants Breakthrough Therapy designation to Genzyme’s olipudase alfa
4 June 2015 | By Victoria White
The FDA has granted Breakthrough Therapy designation to Genzyme’s olipudase alfa for the treatment of Niemann-Pick disease type B...
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Amicus submits EU marketing authorisation application for Fabry monotherapy Galafold
3 June 2015 | By Victoria White
Amicus Therapeutics has submitted a MAA to request full approval in the EU of Galafold for Fabry patients who have amenable genetic mutations...
EC approves Helsinn’s Akynzeo for prevention of chemotherapy-induced nausea and vomiting
3 June 2015 | By Victoria White
The EC has approved Akynzeo for use in the European Union for the prevention of acute and delayed chemotherapy-induced nausea and vomiting...
EMA approves Resolor for use in men for the symptomatic treatment of chronic constipation
3 June 2015 | By
The EMA has approved Resolor for use in adults for the symptomatic treatment of chronic constipation in whom laxatives fail to provide adequate relief...
Results from Phase 2b study of CETP inhibitor TA-8995 published
3 June 2015 | By Victoria White
Dezima Pharma has announced the publication of the phase 2b TULIP study results with its CETP inhibitor, TA-8995, in patients with mild dyslipidaemia...
WHO gives a situation assessment of the MERS-CoV outbreak in Republic of Korea
3 June 2015 | By Victoria White
The outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) in the Republic of Korea continues to evolve, says WHO...
NICE recommends VARGATEF in combination with docetaxel as an option for patients with NSCLC of adenocarcinoma histology
3 June 2015 | By Victoria White
Boehringer Ingelheim’s VARGATEF in combination with docetaxel has been recommended for use within the National Health Service (NHS) in England and Wales...
Trabectedin shown to improve disease control in patients with advanced soft tissue sarcoma
3 June 2015 | By Victoria White
Janssen Research & Development has announced data from a Phase 3 study of trabectedin (YONDELIS) in patients with two common types of soft tissue sarcoma...
AbbVie presents Phase 2 results from study of veliparib in patients with NSCLC who are current smokers
3 June 2015 | By Victoria White
AbbVie has announced findings from a Phase 2 study of a veliparib regimen in patients with non-small cell lung cancer (NSCLC) who are current smokers...
Adding elotuzumab to standard treatment for multiple myeloma significantly reduced the risk of disease progression
3 June 2015 | By Victoria White
Results from an interim analysis of the Phase III ELOQUENT-2 trial of elotuzumab in combination with lenalidomide and dexamethasone have been announced...
FDA accepts sBLA for Keytruda in advanced non-small cell lung cancer, and grants priority review
3 June 2015 | By Victoria White
The FDA has accepted for review the sBLA for Merck’s anti-PD-1 therapy, Keytruda, for the treatment of patients with advanced non-small cell lung cancer...
FDA accepts sBLA for Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma
2 June 2015 | By Victoria White
The FDA has accepted the supplemental Biologics License Application for Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma...
Scancell provides update on Phase 1/2 clinical trial of SCIB1 in Stage III/IV melanoma
2 June 2015 | By Victoria White
Encouraging results have been announced from a Phase 1/2 trial of SCIB1, a DNA ImmunoBody being developed for the treatment of patients with melanoma...
Syrris launches novel quantum dot synthesis system
2 June 2015 | By kdm communications
Syrris, a world leader in chemistry product innovation, has launched the Atlas Nanoparticle System for the automated synthesis of quantum dots...
Urgent action needed to lessen the future impact of atrial fibrillation
2 June 2015 | By Victoria White
The Future of Anticoagulation Report highlights that urgent action is critical to lessening the potential impact of atrial fibrillation...
