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Regulatory Recon: FDA Approves New Shingles Vaccine; NICE Oks Gene Therapy for Rare Condition (23 October 2017) By Zachary Brennan - Published 23 October 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EC, EMA, FDA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Celgene Abandons Late-Stage Trial in Crohn’s Disease (20 October 2017) By Zachary Brennan - Published 20 October 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Europe, US, EMA, FDA, NICE

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

European Regulatory Roundup: EMA Overrode Pharma Concerns in Adopting First-in-Human Guideline (28 September 2017) By Nick Paul Taylor - Published 28 September 2017

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

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

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup

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

The Value of Health Technology Assessment Scientific Advice By Amina Udechuku, PhD, Matthew William Bending, PhD, MSc - Published 23 August 2017

In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. This article discusses how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers.

Categories: Features, Canada, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs

Tags: Health Technology Assessment, HTA

European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017) By Nick Paul Taylor - Published 13 July 2017

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

Categories: News, Europe, EC, EMA, NICE, Biologics and biotechnology, Drugs, Medical Devices

Tags: European Regulatory Roundup, Brexit, reimbursement

Regulatory Recon: FDA Reverses on Amicus’ Fabry Disease Treatment; Sanofi Acquires Protein Sciences (11 July 2017) By Zachary Brennan - Published 11 July 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: FDA Panel to Focus on Safety of CAR-T Therapy (10 July 2017) By Zachary Brennan - Published 10 July 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Europe, US, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

Regulatory Recon: FDA Approves First Strattera Generics; UK’s NICE Backs Keytruda (31 May 2017) By Zachary Brennan - Published 31 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EMA, FDA, Health Canada, NICE, TGA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

Canada Proposes to Amend Drug Pricing Regulations By Zachary Brennan - Published 17 May 2017

For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs.

Categories: News, Canada, US, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: drug pricing, Canada drug prices, QALY, PMPRB, generic drugmakers

EU Health Tech Assessments: Majority Favor Continuing Beyond 2020 By Zachary Brennan - Published 15 May 2017

A majority of respondents to a European Commission questionnaire says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: HTA, health technology assessments, European Commission report

Regulatory Recon: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017) By Zachary Brennan - Published 12 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, CFDA, EMA, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

WHO Officials Offer Opposition to Value-Based Drug Pricing By Zachary Brennan - Published 12 May 2017

World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing systems.

Categories: News, Asia, Canada, Europe, US, NICE, WHO, Biologics and biotechnology, Drugs, Government affairs

Tags: WHO on drug pricing, fair pricing forum, pharmaceutical pricing

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit By Zachary Brennan - Published 21 April 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices

Tags: UK MHRA business plan, UK medical devices, pharmaceutical regulations

Regulatory Recon: FDA Advisers Vote Against OTC Combos for Minor Stomach Issues; FDA Commissioner Nominee Faces Senate Committee (5 April 2017) By Zachary Brennan - Published 05 April 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Africa, Asia, Europe, US, EC, EMA, FDA, MHRA, NICE, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Alexion to Lay Off More Than 200; FDA Approves Novartis Breast Cancer Treatment (14 March 2017) By Zachary Brennan - Published 14 March 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, DOJ, EC, EMA, FDA, Health Canada, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA By Zachary Brennan - Published 14 March 2017

The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in continuing UK participation in the European Medicines Agency (EMA).

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs

Tags: Brexit, UK in EMA, House of Lords

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

Regulatory Recon: New Global Pharma Head for GSK; Pharma CEOs Discuss Trump (20 January 2017) By Zachary Brennan - Published 20 January 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, NICE, Biologics and biotechnology, Combination products, Drugs, Human cell and tissue, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

Regulatory Recon: Big Ruling Against Sanofi and Regeneron; Obama on Repealing Obamacare (6 January 2017) By Zachary Brennan - Published 06 January 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, EC, EMA, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News<

European Regulatory Roundup: EMA Reviews Drugs Tested at Two Indian Sites (23 December 2016) By Nick Paul Taylor - Published 23 December 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, Drugs

Tags: European Regulatory Roundup, CHMP, GCP