spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA Europe in Basel

NDA Group

More approvals and more novel drugs, Small and Medium Sized Pharma Dominate, Precedence setting FDA oncology approval

Today NDA Group announced their findings from its fifth annual comparison of drug approvals in Europe and the United States, in preparation for this year’s DIA Europe in Basel, Switzerland. The figures highlight the continued differences between the two regions, and the need for a global approach to drug development to ensure success across both continents.

This year’s report – based on preliminary research figures distilled from the EMA and FDA websites in January 2018 – found that once again, we see more approvals and also more novel drugs approved compared to 2016 year’s drop. For 2017 there were a total of 103 new drug approvals granted in the US and EU. Of these new products, 15 were approved only in the EU, 52 only in the US, and 36 were granted in both regions. 56 of the drugs were classified as novel drugs, 6 were approved only in the EU, 27 only in the US and 23 in both regions.

Johan Strömquist, CEO, NDA Group “We are pleased to see that the drug approvals are increasing again compared to 2016 year’s figures. It’s also interesting to see that for the first time since we started to analyse the drug approvals small and medium sized pharma are ahead of big pharma.”

“Our analysis for 2017 shows that NDA maintains an exceptional position in supporting new drug product approvals in Europe. During the last five years NDA supported over 40% of the new drugs approved with a broad range of services. This is particularly exciting as an increasing proportion of products are emerging based on highly innovative and ground-breaking technologies. This is where we at NDA Group truly excels.”


Dr Terese Johansson, NDA’s consultant behind the research commented:
“The findings released today show some precedence setting new approvals. In the US the Keytruda, (pembrolizumab) approval in oncology demonstrates the shift from defining cancers by the site at which they occur toward a definition by the molecular changes that drives the tumorigenesis. This approval is likely to have implications for how the drug development process is pursued in the future, particularly in oncology, but most likely also for other therapeutic areas as science progresses. Looking at the therapeutic areas, the far busiest was oncology. With a total of 27 new oncology approvals, so far 12 of these are only approved in the US. Moreover, the first digital pill (Abilify MyCite, aripiprazole) has seen the light of day in US.”

Highlighted in the report released today are also some noteworthy Orphan approvals. With more treatments for orphan diseases hitting the market the pricing of these drugs becomes increasingly important. Terese Johansson continues: “Drug developers are meeting the treatment demand from the patients and physicians but are the payers willing to pay the price? Drug developers will benefit from being prepared early on to develop strategies to ensure patient access and affordability of their orphan drugs.”

Terese Johansson continues:

“Drug developers are meeting the treatment demand from the patients and physicians but are the payers willing to pay the price? Drug developers will benefit from being prepared early on to develop strategies to ensure patient access and affordability of their orphan drugs.”




Big pharma represented 49% of the new drug approvals in 2017 vs 51% of the new approvals originating from small and medium sized pharma. For big pharma this is a decrease compared to previous years. Of all new products that received marketing approval in 2017, 43 products underwent special approval procedures like Conditional, Fast Track, Breakthrough, Accelerated Approval and Priority Review, 33 only in the US, six only in EU and four granted in both the US and EU. In many cases more than one of these pathways was granted per product

NDA Strategic Advisor and former Chief Exec of the EMA, Dr. Thomas Lönngren, as well as the company’s Scientific Director, Dr. Markku Toivonen and the Director of NDA’s Regulatory Advisory Board, Prof. Steffen Thirstrup will be present at DIA Europe together with a line-up of experts, and available to discuss these findings. In addition, Hildegard Schmatz, one of NDA’s Brexit experts will be available to advice on how to ensure that your company is ‘BREXIT-ready’.

NDA staff can be found at booths C 72 and 73 and in the following presentations:

Shelley Gandhi & Bill Richardson - Ex MHRA Regulators
(Pre-Conference Short Course) Short Course 3 | Mon, 16th April - 14:00-17:30
Moving from Risk Management to Benefit / Risk Management - Embedding Pharmacovigilance Principles into the product life cycle

Beatriz Silva Lima - Non-Clinical Expert DIAlogue 2 – Session 1100 | Tues, 17th April - 14:00-15:30
The New EMA first-in-human (FIH) guideline Part1: Non- Clinical aspects
Brian Edwards - Principal Consultant, Pharmacovigilance & Drug Safety
Session 0502 | Wed, 18th April - 14:00-15:15
  • Innovative approaches to safety information
  • A proposal for a new systems-based approach to medication errors
Shelley Gandhi - Strategic Advisor, Pharmacovigilance & Drug Safety
Session 0504 | Thurs, 19th April - 08:30-10:00
Five years on - pharmacovigilance legislation Delivers on long-promised elements


For more about NDA’s involvement with the 2018 DIA Europe, visit http://www.ndareg.com/6274-2/

To explore the full Status of New Drug Approvals for 2017 report, visit http://www.ndareg.com/europe-vs-usa-new-drug-product-approvals-in-2017/

About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Princeton, Boston, San Francisco and Paris. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional drug development services focusing on regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team of more than 150 full time professionals is comprised of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies. www.ndareg.com

NDA media contact: anna.perrin@ndareg.com

phone +46 (0)8 590 778 00
email info@ndareg.com
web www.ndareg.com/
email Oxford House Johanneslundsv. 2 S-194 81 Upplands Väsby
 
Print this page
Send to a friend
   
spacer
News and Press Releases

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
More info >>


White Papers

7 Common Myths about QP Training Debunked: A Guide for Senior Managers

RSSL

The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.
More info >>

Industry Events

T3: Trials, Tech and Transformation

30-31 May 2018, Raleigh Convention Center, Raleigh, NC

T3 is back for 2018 to provide you with the latest updates and top tips from across the clinical trials landscape. Connecting leading experts, influencers and innovators from pharma, biotech, CROs, patient advocacy groups, academia and beyond, T3 is themeeting place for all stakeholders to voice their questions, connect with peers, and get direct feedback from an expert speaker line-up.And this year, we're in Raleigh.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement