Search Results for NICE

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England Reimbursement Profile By Vishal Patel - Published 18 September 2017

This profile summarizes the reimbursement process in England, presents key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Europe, MHRA, NICE, Biologics and biotechnology, Drugs, Reimbursement

Tags: NICE, NHS, Reimbursement

NICE, Roche Reach Deal on Breast Cancer Drug By Michael Mezher - Published 15 June 2017

Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday.

Categories: News, Europe, NICE, Biologics and biotechnology, Reimbursement

Tags: NICE, Roche, Kadcyla, Herceptin, Trastuzumab

UK's NICE to Launch New Online Tool for Med Tech Developers Published 31 May 2017

The UK's National Institute for Health and Care Excellence (NICE), which often determines if the UK can afford to pay for certain treatments, will launch a new online tool in July to help developers of medical devices and diagnostics understand how to generate the evidence necessary to show their products are clinically and cost effective.

Categories: News, Europe, NICE, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical technologies, medical devices, cost effectiveness of medical tech

European Regulatory Roundup: UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit (26 January 2017) By Nick Paul Taylor - Published 26 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Business and Leadership, Drugs, Government affairs, Medical Devices

Tags: European Regulatory Roundup, Brexit, Theresa May, NICE Chair

NICE Halts Plans to Charge for Appraisals By Zachary Brennan - Published 16 January 2017

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Reimbursement

Tags: Brexit, UK Life Sciences, ABPI, NICE

NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage By Zachary Brennan - Published 15 December 2016

The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to new medical devices, diagnostics and other health-related technologies.

Categories: News, Europe, US, CDRH, NICE, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical device insurer coverage, medical devices and approval

NICE to Charge up to £282,000 for Each New Drug Assessment By Zachary Brennan - Published 03 October 2016

The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year.

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices

Tags: NICE assessment, NICE fees, EMA and HTA parallel assessment

NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta By Michael Mezher - Published 22 June 2016

The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS).

Categories: News, Europe, NICE, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration

Tags: Zykadia, Mekinist, Praluent, Repatha, Humira, Benlysta, NICE, NHS

European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016) By Nick Paul Taylor - Published 03 March 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: good pharmacovigilance practices, NICE, Cancer Drugs Fund, Swissmedic

European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016) By Nick Paul Taylor - Published 11 February 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Veterinary products

Tags: NICE, Xarelto, Paluent, Sanofi, Amgen, ENVI

European Regulatory Roundup: EMA Looks to Harmonize Definition of Drug Shortage (28 January 2016) By Nick Paul Taylor - Published 28 January 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing

Tags: EMA, drug shortages, NICE, EGA

European Regulatory Roundup: EMA Looks to Further Prevent Medication Errors (3 December 2015) By Nick Paul Taylor - Published 03 December 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Ethics, Government affairs, Medical Devices, Quality, Reimbursement, Research and development

Tags: EMA, NICE, MHRA, European drug regulations

UK Agencies Look to Overhaul Cancer Drugs Fund By Zachary Brennan - Published 19 November 2015

The National Health Service (NHS) of England and the National Institute for Health and Care Excellence (NICE) on Thursday introduced a new proposal to transform the £340 million ($520 million) Cancer Drugs Fund (CDF) to allow patients to have earlier access to new treatments while real-world evidence is still being collected.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Blood, Crisis management, Drugs, Government affairs, Preclinical, Quality, Reimbursement, Research and development

Tags: cancer drugs, biotech, NICE, NHS, UK cancer drugs, EMA

European Regulatory Roundup: EMA Unveils Antimicrobial Strategy (19 November 2015) By Nick Paul Taylor - Published 19 November 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, NICE, Distribution, Drugs, Due Diligence, Ethics, Government affairs, Medical Devices

Tags: EMA, NICE, MHRA, CVMP, CHMP, cholesterol drugs, PCSK9

NICE to Work Earlier With Industry to Speed NHS Adoption of New Drugs, Devices By Zachary Brennan - Published 13 October 2015

The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS).

Categories: News, Europe, NICE, Biologics and biotechnology, Combination products, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Reimbursement

Tags: NICE, NHS, Office for Market Access, health technology evaluations, cost-effectiveness studies

UK to Launch New Office for Market Access By Michael Mezher - Published 28 May 2015

The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies.

Categories: News, Europe, EMA, NICE, Clinical, Government affairs, Regulatory strategy, Reimbursement, Research and development, Submission and registration

Tags: NICE, Early Access to Medicines Scheme, EAMS, conditional marketing authorisation, adaptive pathways, Office for Market Access, OMA

NICE Urges Review of Drug Evaluation Methodology By Louise Zornoza, RegLink News - Published 18 September 2014

Following public criticism of its rejection of a number of expensive cancer treatments, the UK’s health cost watchdog is calling for a review of the way new medicines are adopted by the National Health Service.  

Categories: News, Europe, Reimbursement

Tags: NICE, UK, NHS, National Health Service

NICE Recommends Biogen Idec’s Tecidera for Multiple Sclerosis By Louise Zornoza, RegLink News - Published 28 August 2014

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Biogen Idec's multiple sclerosis drug, dimethyl fumarate (Tecfidera) as a treatment option for adults with relapsing-remitting multiple sclerosis.

Categories: News, Europe, NICE, Prescription drugs, Reimbursement

Tags: NICE, UK, Tecfidera, Dymethyl Fumarate, MS, Multiple Sclerosis

UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns By Louise Zornoza, RegLink News - Published 08 August 2014

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage.

Categories: News, Europe, NICE, Reimbursement

Tags: NICE, Final Draft Guidance, Roche, Kadcyla, Breast Cancer, Cost