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Page 1
Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Baden LR, et al. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30. N Engl J Med. 2021. PMID: 33378609 Free PMC article. Clinical Trial.
(Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)....
(Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; …
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase.
El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, Campbell TB, Clark J, Jackson LA, Fichtenbaum CJ, Zervos M, Rankin B, Eder F, Feldman G, Kennelly C, Han-Conrad L, Levin M, Neuzil KM, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Polakowski L, Mascola JR, Ledgerwood JE, Graham BS, August A, Clouting H, Deng W, Han S, Leav B, Manzo D, Pajon R, Schödel F, Tomassini JE, Zhou H, Miller J; COVE Study Group. El Sahly HM, et al. N Engl J Med. 2021 Nov 4;385(19):1774-1785. doi: 10.1056/NEJMoa2113017. Epub 2021 Sep 22. N Engl J Med. 2021. PMID: 34551225 Free PMC article. Clinical Trial.
BACKGROUND: At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to …
BACKGROUND: At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% effica …
Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults.
Denkinger M, Knol W, Cherubini A, Simonds A, Lionis C, Lacombe D, Petelos E, McCarthy M, Ouvrard P, Van Kerrebroeck P, Szymański P, Cupelli A, Laslop A, Koch A, Sepodes B, Torre C, Rönnemaa E, Bałkowiec-Iskra E, Herdeiro MT, Rosa MM, Trauffler M, Mirošević Skvrce N, Mayrhofer S, Berntgen M, Silva I, Cerreta F. Denkinger M, et al. Lancet Healthy Longev. 2023 Dec;4(12):e724-e729. doi: 10.1016/S2666-7568(23)00208-8. Epub 2023 Nov 15. Lancet Healthy Longev. 2023. PMID: 37977177 Free article. Review.
The recommendations presented here are relevant for stakeholders, authorities, pharmaceutical companies, and researchers alike, as the implementation of these measures is not under the capacity of a single entity. ...
The recommendations presented here are relevant for stakeholders, authorities, pharmaceutical companies, and researchers alike, as th …
Evolving regulatory perspectives on digital health technologies for medicinal product development.
Colloud S, Metcalfe T, Askin S, Belachew S, Ammann J, Bos E, Kilchenmann T, Strijbos P, Eggenspieler D, Servais L, Garay C, Konstantakopoulos A, Ritzhaupt A, Vetter T, Vincenzi C, Cerreta F. Colloud S, et al. NPJ Digit Med. 2023 Mar 29;6(1):56. doi: 10.1038/s41746-023-00790-2. NPJ Digit Med. 2023. PMID: 36991116 Free PMC article. Review.
These case studies are the main examples of DHTTs with a regulatory assessment thus far, providing an insight into the applicable current regulatory approach; they were selected by a group of authors, including regulatory specialists from pharmaceutical sponsors, technolog …
These case studies are the main examples of DHTTs with a regulatory assessment thus far, providing an insight into the applicable current re …
Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects.
van Riet-Nales DA, Hussain N, Sundberg KA, Eggenschwyler D, Ferris C, Robert JL, Cerreta F. van Riet-Nales DA, et al. Int J Pharm. 2016 Oct 30;512(2):343-351. doi: 10.1016/j.ijpharm.2016.05.001. Epub 2016 May 2. Int J Pharm. 2016. PMID: 27150947 Free article. Review.
Furthermore, attention is paid to work in progress e.g. incentives by the European national drug regulatory authorities, and patient centric drug product development....
Furthermore, attention is paid to work in progress e.g. incentives by the European national drug regulatory authorities, and patient …
Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults.
Reginster JY, Beaudart C, Al-Daghri N, Avouac B, Bauer J, Bere N, Bruyère O, Cerreta F, Cesari M, Rosa MM, Cooper C, Cruz Jentoft AJ, Dennison E, Geerinck A, Gielen E, Landi F, Laslop A, Maggi S, Prieto Yerro MC, Rizzoli R, Sundseth H, Sieber C, Trombetti A, Vellas B, Veronese N, Visser M, Vlaskovska M, Fielding RA. Reginster JY, et al. Aging Clin Exp Res. 2021 Jan;33(1):3-17. doi: 10.1007/s40520-020-01663-4. Epub 2020 Jul 31. Aging Clin Exp Res. 2021. PMID: 32737844 Free PMC article. Review.
Detection of a characteristic melting profile of a SARS-CoV-2 Kappa variant in Italy using the SARS-CoV-2 Variants ELITe MGB® Kit.
Scapaticci M, Bartolini A, Vitone F, Cerreta V, Vignoli M, Gnudi E, Frazzoni A, Sitta B, Capitani S, Lopriore A, Donadio M, Chiarastella S, Bioli M, Mancini R. Scapaticci M, et al. J Virol Methods. 2022 Mar;301:114458. doi: 10.1016/j.jviromet.2022.114458. Epub 2022 Jan 10. J Virol Methods. 2022. PMID: 35026304 Free PMC article.
20 results