Former EMA head to advise NDA Group business
Thomas Lönngren joins new European regulatory and market access business
Thomas Lönngren, previously executive director of the European Medicines Agency (EMA), will take a strategic advisory role in the new business.
The organisation said NDA’s Advisory Board would be integral integral to NDA Advisory Services and will be expanded to include HTA and market access capabilities.
New specialists are to join the Advisory Board to advise pharmaceutical companies on how they can prove the value of their products to national agencies.
Lönngren will play a fundamental role in the new business, building on 30 years’ experience in the regulatory field including the last 10 years heading EMA. One of his key ambitions is to create a co-ordinated approach to Health Technology Assessment and improve market access in Europe.
‘I’ve recognised for a long time that the whole area of market access needs new ideas and a new vision,’ he said.
‘I plan to further develop my ideas surrounding International Regulatory Strategies, coupled with pushing for a joined-up approach to HTA, to enable the best medicines to reach needy patients as efficiently as possible.’
NDA has offices in Germany, Sweden and the UK.
You may also like
Regulatory
WHO prequalifies Novartis' antimalarial Coartem Baby for treatment of newborns and young infants
The decision allows global procurement of artemether-lumefantrine (also known as Riamet Baby in some countries) for the first time, with Novartis adding that it will make the treatment available on a largely not-for-profit basis in malaria-endemic regions
Regulatory
FDA approves AstraZeneca's Saphnelo Pen autoinjector in systemic lupus erythematosus
AstraZeneca has received FDA approval for a once-weekly subcutaneous autoinjector formulation of Saphnelo for systemic lupus erythematosus, offering patients a more convenient alternative to the existing intravenous infusion
You need to be a subscriber to read this article.
Click here to find out more.
Click here to find out more.
Regulatory
UK clinical trial reforms come into force in largest regulatory overhaul in 20 years
The MHRA and Health Research Authority are implementing the most significant package of clinical trial regulatory reforms in more than two decades, introducing faster assessment routes for lower-risk trials and mandatory registration of trial results
Regulatory
FDA grants Orphan Drug Designation to pegrizeprument for prevention of heart transplant rejection
The FDA has granted Orphan Drug Designation to pegrizeprument (VEL-101), a novel monoclonal antibody fragment licensed to Veloxis Pharmaceuticals, for the prevention of heart allograft rejection, following a similar designation granted for liver transplant rejection in January 2026
You need to be a subscriber to read this article.
Click here to find out more.
Click here to find out more.
Regulatory
Britain's biotech potential (part I): world-class science, second-class support?
The UK produces top-tier life sciences research, offers favourable conditions for early-stage investment and hosts a growing network of internationally competitive clusters. So why does the capital keep leaving?
Manufacturing
FDA issues first cGMP warning letter citing AI misuse in pharmaceutical manufacturing
A Michigan-based lab has become the subject of the FDA's first dedicated enforcement action on artificial intelligence misuse in drug manufacturing — a landmark event with far-reaching implications for cGMP compliance across the pharmaceutical supply chain