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Filtering on: "geography europe"

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European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017) By Nick Paul Taylor - Published 21 September 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines

EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias By Zachary Brennan - Published 21 September 2017

Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: EU ombudsman, early regulator engagement, pre-submission meetings

France Reimbursement Profile By Jenifer Ehreth, MHA, PhD - Published 20 September 2017

This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process.

Categories: Features, Europe, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement

Tags: ANSM, ACAM, CEESP, CEPS, Reimbursement, France

UK’s MHRA Unveils Human Factors Guidance for Medical Devices By Zachary Brennan - Published 19 September 2017

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.

Categories: News, Europe, EC, MHRA, Combination products, Government affairs, In vitro diagnostics, Medical Devices

Tags: human factors guidance for medical devices, MHRA guidance, MDR

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

EMA Finds No Difference in Inhibitor Risk Between Factor VIII Classes By Michael Mezher - Published 18 September 2017

The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines.

Categories: News, Europe, EMA, Biologics and biotechnology, Blood

Tags: Factor VIII, Inhibitor, Hemophilia A

Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 2017) By Zachary Brennan - Published 15 September 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

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

Italy Reimbursement Profile By Patrizia Berto, PharmD, MBA - Published 14 September 2017

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

Categories: Features, Europe, EMA, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement

Tags: AIFA, Agenzia Italiana del Farmaco, Reimbursement

European Regulatory Roundup: EMA Explains its Regulatory System (14 September 2017) By Nick Paul Taylor - Published 14 September 2017

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

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

Tags: HPRA, ENVI, CVMP, DKMA

Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake By Zachary Brennan - Published 13 September 2017

Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs

Tags: biosimilars, interchangeable biosimilars

European Regulatory Roundup: EU Committee Slams Plan to Cut EMA Staffing Ahead of Brexit (7 September 2017) By Nick Paul Taylor - Published 07 September 2017

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

Categories: News, Europe, EC, EMA, Drugs, Medical Devices

Tags: European Regulatory Roundup, Brexit, EMA staff cuts

CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers By Zachary Brennan - Published 06 September 2017

About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.

Categories: News, Asia, Europe, US, CDRH, Manufacturing, Medical Devices

Tags: warning letters, medical device warnings

The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US By Zachary Brennan - Published 05 September 2017

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars

EMA Opens Consultations of Two Revised ICH Guidelines By Zachary Brennan - Published 31 August 2017

The European Medicines Agency (EMA) on Thursday released for consultation a revised ICH guideline on reproductive toxicology and an addendum to another guideline on statistical principles for clinical trials.

Categories: News, Canada, Europe, US, EMA, ICH, Clinical, Drugs

Tags: ICH E9, ICH S5

IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018 By Zachary Brennan - Published 31 August 2017

The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, Health Canada, ICH, MHRA, WHO, Drugs, Regulatory intelligence, Regulatory strategy

Tags: IPRF, IGDRP, pharmaceutical regulations

European Regulatory Roundup: Industry Seeks Post-Brexit System Prioritizing Ties to EMA (31 August 2017) By Nick Paul Taylor - Published 31 August 2017

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

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

Tags: Brexit, medical device directives, PSUR

MHRA Offers Interactive Guide on New EU Device, IVD Regulations By Zachary Brennan - Published 29 August 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released an introductory guide to help medical device manufacturers understand their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR).

Categories: News, Europe, EC, MHRA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDR, IVDR, EU device regulations

FDA Approves 6th Biosimilar in US, Second for Humira By Zachary Brennan - Published 28 August 2017

The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab).

Categories: News, Europe, US, FDA, Biologics and biotechnology, Submission and registration

Tags: biosimilars US approval, Boheringer Ingelheim, Cyltezo, Humira

European Regulatory Roundup: UK Calls for Brexit to Have Little Impact on Regulation (24 August 2017) By Nick Paul Taylor - Published 24 August 2017

The United Kingdom government has released a paper setting out its position on issues that will affect the availability of goods after Brexit. UK politicians want many regulatory factors relevant to drugmakers to remain the same immediately after Brexit, but to achieve this goal they will need persuade European negotiators to revise their position.

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

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

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

EMA and FDA to Begin Sharing Commercially Confidential Information By Zachary Brennan - Published 23 August 2017

As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will now share non-public and commercially confidential information, including trade secret information.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory strategy

Tags: EMA and FDA agreement, mutual recognition agreement, GMP inspection reports

Pfizer Wins Indian Patent on Prevnar 13 Vaccine By Zachary Brennan - Published 22 August 2017

India’s patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims.

Categories: News, Asia, Europe, US, Crisis management, Drugs, Regulatory strategy

Tags: Prevnar 13, Pfizer, PCV, pneumonia vaccine

Regulatory Recon: J&J Pays $417M for Baby Powder Link to Cancer (22 August 2017) By Zachary Brennan - Published 22 August 2017

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

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, PMDA, WHO, Drugs, Government affairs, Medical Devices

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

European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017) By Nick Paul Taylor - Published 17 August 2017

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

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

Tags: European regulatory roundup, Ireland biosimilars, CROs

Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017) By Zachary Brennan - Published 17 August 2017

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

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

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