T
Tomas Salmonson
Researcher at Medical Products Agency
Publications - 56
Citations - 1751
Tomas Salmonson is an academic researcher from Medical Products Agency. The author has contributed to research in topics: European union & Population. The author has an hindex of 23, co-authored 53 publications receiving 1500 citations. Previous affiliations of Tomas Salmonson include European Medicines Agency.
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Journal ArticleDOI
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
H G Eichler,Lynn G. Baird,R Barker,Brigitte Bloechl-Daum,F Børlum‐Kristensen,Jeffrey S. Brown,R Chua,S Del Signore,U Dugan,J Ferguson,Sarah Garner,Wim G. Goettsch,J Haigh,Peter Honig,Anton Hoos,P Huckle,Tatsuya Kondo,Y Le Cam,Hubert G. M. Leufkens,Hubert G. M. Leufkens,Robyn Lim,Carole Longson,Murray Lumpkin,J Maraganore,Brian O'Rourke,Kenneth A. Oye,E Pezalla,Francesco Pignatti,J Raine,J Raine,Guido Rasi,Guido Rasi,Tomas Salmonson,D. Samaha,Sebastian Schneeweiss,PD Siviero,M Skinner,JR Teagarden,Toshiyoshi Tominaga,Trusheim,S. Tunis,Thomas F. Unger,Spiros Vamvakas,Gigi Hirsch +43 more
TL;DR: The environmental changes that will likely make adaptive pathways the preferred approach in the future are examined and a life‐span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade‐off, help de‐risk drug development, and lead to better outcomes for patients.
Journal ArticleDOI
European Medicines Agency review of ataluren for the treatment of ambulant patients aged 5 years and older with Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene
Manuel Haas,Viktor Vlcek,Pavel Balabanov,Tomas Salmonson,Serge Bakchine,Greg Markey,Martina Weise,Gabriele Schlosser-Weber,Henning Brohmann,Concepcion Prieto Yerro,Macarena Rodriguez Mendizabal,Violeta Stoyanova-Beninska,Hans L. Hillege +12 more
TL;DR: First in class medicine ataluren received conditional approval in Europe for treatment of Duchenne disease.
Journal ArticleDOI
A regulatory Apologia--a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants.
TL;DR: Statistically significant mean differences versus placebo in change in HAMD are not a proper basis for evaluation of clinical relevance and are not sufficient for approval, while differences in the percentage of patients experiencing a clinically relevant response should also be demonstrated.
Journal ArticleDOI
The risks of risk aversion in drug regulation
Hans-Georg Eichler,Brigitte Bloechl-Daum,Daniel Brasseur,Alasdair Breckenridge,Hubert G. M. Leufkens,June Raine,Tomas Salmonson,Christian K. Schneider,Guido Rasi +8 more
TL;DR: The consequences of regulatory risk-aversion for public health are discussed and what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health is suggested.
Journal ArticleDOI
Accelerated access to innovative medicines for patients in need
Lynn G. Baird,R. Banken,H G Eichler,Finn Børlum Kristensen,David K Lee,John C W Lim,Robyn Lim,Carole Longson,E Pezalla,Tomas Salmonson,D. Samaha,S. Tunis,Janet Woodcock,Gigi Hirsch +13 more
TL;DR: Specific approaches to early access to new and innovative medicines in four economically developed regions are described, their success rates are reviewed, and possible new directions are suggested.