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NICE recommends access to venclyxto for adult leukaemia
NICE has issued a final appraisal determination recommending that venclyxto is made available to patients with chronic lymphocytic leukaemia...
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Medtech sales to reach $522bn by 2022
EvaluateMedTech World Preview provides a range of insights into the expected performance of the medtech industry...
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Kadcyla new deal means NICE positive recommendation in draft guidance
A new deal on the breast cancer drug trastuzumab emtansine means that it can now be recommended for routine funding.
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FDA approves Roche’s lung cancer companion diagnostic
6 June 2017 | By Niamh Marriott, Junior Editor
The FDA have approved Roche’s VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients...
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Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research
16 May 2017 | By European Federation of Pharmaceutical Industries and Associations (EFPIA)
The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with quality medicines
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Roche receives FDA approval for bladder cancer biomarker assay
5 May 2017 | By Niamh Marriott, Junior Editor
The FDA has approved Roche’s biomarker assay as a complementary diagnostic to provide PD-L1 status for patients with urothelial carcinoma...
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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…
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2017 Pipelines: Drugs to watch
The annual Drugs to Watch report forecasts that eight new drugs will enter the market in 2017 and achieve blockbuster sales of more than $900 billion by 2021...
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The top 21… wealthiest pharma companies
European Pharmaceutical Review has been keeping the industry informed for 21 years and continues to bring insights into current and emerging technologies, contributions from recognised figures in the life science community and of course, the latest and most up to date news. To celebrate our success, we will be counting down…
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FDA approves Roche’s assay to assess ovarian reserve
10 January 2017 | By Niamh Marriott, Digital Editor
The blood test produces standardised results for assessing ovarian reserve as compared with the use of vaginal ultrasound...
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NICE says Roche’s trastuzumab emtansine too expensive for routine NHS use
29 December 2016 | By Niamh Louise Marriott, Digital Editor
Trastuzumab emtansine is currently being funded through the Cancer Drugs Fund (CDF). NICE is looking again at its 2015 guidance to see whether it should...
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Price discount helps give green light for Roche’s breast cancer drug
21 November 2016 | By Niamh Louise Marriott, Digital Content Producer
A discount to the price of pertuzumab agreed with the company was an important factor in enabling NICE to overturn its earlier provisional decision...
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GSK tops list ranking big pharma’s global access to medicine
14 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Read how the 2016 Access to Medicine Index ranks the top 20 pharmaceutical companies on their efforts to improve access to medicine in low- and middle-income countries...
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Prothena’s Phase 1b Parkinson’s disease study showed robust antibody CNS penetration
11 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Prothena’s Phase 1b multiple ascending dose study of PRX002 trial found an acceptable safety and tolerability profile in patients with Parkinson’s disease...
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FDA approves Roche’s immunotherapy assay to support treatment decisions in lung cancer
31 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The US Food and Drug Administration (FDA) has approved Roche’s PD-L1 assay as a diagnostic to identify PD-L1 expression levels in patients considering treatment with Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC)…
