Innovative drug delivery platform relies on Telos® Reagent Chips
4 May 2017 | By Dolomite Microfluidics
Telos® 2 Reagent Chips from Dolomite Microfluidics have helped San Francisco-based ProLynx LLC to develop a novel drug delivery platform...
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First ever evidence of treatment-induced reduction in HIV reservoirs
4 May 2017 | By Niamh Marriott, Junior Editor
Abivax’s lead therapeutic candidate ABX464 demonstrated the first reduction in HIV reservoirs ever observed in chronically infected HIV patients...
FDA approves Roche’s high-volume immunoassay
4 May 2017 | By Niamh Marriott, Junior Editor
Roche’s new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyser series, the cobas e 801 module, has received 510(k) clearance from the US Food and Drug Administration (FDA). As core laboratories continue to evolve to meet the growing workload demands in an increasingly challenging environment, the cobas…
FDA approves new combination treatment for acute myeloid leukaemia
4 May 2017 | By Niamh Marriott, Junior Editor
The drug is approved for use in combination with LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML...
AstraZeneca’s bladder cancer treatment receives FDA approval
3 May 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) to treat metastatic urothelial carcinoma...
EC extends approval for Janssen’s daratumumab to include multiple myeloma patients
3 May 2017 | By Niamh Marriott, Junior Editor
The EC has granted approval to Janssen Daralex (daratumumab) for use in combination, for the treatment of adult patients with multiple myeloma (MM)...
FDA accepts Sanofi and Regeneron’s biologics license resubmission
2 May 2017 | By Niamh Marriott, Junior Editor
The FDA has accepted the resubmission of Sanofi and Regeneron Pharmaceuticals’ Biologics License Application for Kevzara (sarilumab)...
FDA expands approved use of Bayer’s liver cancer treatment
2 May 2017 | By Niamh Marriott, Junior Editor
The FDA has expanded the approved use of Bayer's Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma...
NICE recommends Janssen’s Crohn’s Disease biological therapy
2 May 2017 | By Niamh Marriott, Junior Editor
NICE has recommended Stelara (ustekinumab) in its final appraisal determination as a treatment option for adult patients with Crohn’s disease...
Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...
Novartis real-world data confirms benefit of Gilenya in relapsing MS
28 April 2017 | By Niamh Marriott, Junior Editor
Novartis announced data from the MS-MRIUS study, which confirmed the effectiveness of Gilenya (fingolimod) in the real-world setting...
SIRT is better tolerated than sorafenib, but doesn’t increase overall survival in HCC
28 April 2017 | By Niamh Marriott, Junior Editor
Results of the SARAH trial demonstrate that SIRT resulted in median overall survival (OS) of 8.0 months compared to 9.9 months with sorafenib (p=0.179)...
12 months on: European Commission present updates on GDPR timelines and objectives at 7th annual BioBanking Industry Summit
27 April 2017 | By SMi Group
Legal advisor and policy analyst to provide opening keynote on the Impact of the General Data Protection Regulation (GDPR) on collaborative science in Europe.
AstraZeneca’s lung cancer drug receives full approval in the EU
27 April 2017 | By Niamh Marriott, Junior Editor
The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Novartis to globally co-commercialise Amgen’s migraine drug
27 April 2017 | By Niamh Marriott, Junior Editor
Novartis has expanded their commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine...
