Results 51 to 60 of about 1,709,620 (289)

Amivantamab and Mobocertinib in Exon 20 insertions EGFR Mutant Lung Cancer, Challenge To The Current Guidelines

Translational Oncology, 2022
In 2021, the US Food and Drug Administration (FDA) approved two drugs targeting exon 20 directly: amivantamab and mobocertinib, under the accelerated approval pathway, for adult patients with locally advanced or metastatic non-small cell lung cancer ...
Timothée Olivier, Vinay Prasad
doaj   +1 more source

Regulatory withdrawal of medicines marketed with uncertain benefits : the bevacizumab case study [PDF]

, 2015
Acknowledgements Professor Elizabeth Roughead is funded by a Future Fellowship from the Australian Research Council. The views expressed are those of the authors, the sponsor had no role in the preparation of the manuscript.Peer reviewedPublisher ...
Entwistle, Vikki, Nguyen, Tuan, Roughead, Elizabeth, Vitry, Agnes   +3 more
core   +1 more source

Looking for a new panacea in ALK-rearranged NSCLC: may be Ceritinib? [PDF]

, 2014
In the past decade, the advent of targeted therapy led to a silent revolution in the war against lung cancer and a significant evolution on the concept of Phase I clinical trials design.
PASSIGLIA, Francesco, Pauwels, P., Rolfo, C, RUSSO, Antonio   +3 more
core   +1 more source

Accelerated Approval of Highly Expensive Disease-modifying Agents: Lessons Learned From the Aducanumab Approval

Journal of Pharmacoeconomics and Pharmaceutical Management, 2022
Alzheimer’s disease (AD) is a neurodegenerative disease and the most common cause of dementia affecting millions of people yearly. On June 7, 2021, the U.S FDA granted accelerated approval to highly expensive Aducanumab (Aduhelm), the first-ever disease-
Santenna Chenchula, Padmavathi R.
doaj  

Developing and testing accelerated partner therapy for partner notification for people with genital Chlamydia trachomatis diagnosed in primary care: a pilot randomised controlled trial [PDF]

, 2015
Background Accelerated partner therapy (APT) is a promising partner notification (PN) intervention in specialist sexual health clinic attenders. To address its applicability in primary care, we undertook a pilot randomised controlled trial (RCT) of two
Althaus, Andrew Copas, Anne M Johnson, Bailey, Cassell, Catherine H Mercer, Centers for Disease Control and Prevention, Chen, Claudia S Estcourt, Cowan, Estcourt, Estcourt, Ferreira, Greta Rait, Götz, Jackie A Cassell, Kazeem Aderogba, Laura Tickle, Lorna J Sutcliffe, Louise J Jackson, Low, Low, McCarney, McNulty, McNulty, McNulty, Mercer, Mercer, Mercer, Merle Symonds, Miller, Pamela Muniina, Roberts, Sarah Creighton, Shackleton, Tracy E Roberts, Turner   +36 more
core   +6 more sources

Accelerated return to sport after osteochondral autograft plug transfer [PDF]

, 2017
Background:Previous studies have reported varying return-to-sport protocols after knee cartilage restoration procedures.Purpose:To (1) evaluate the time for return to sport in athletes with an isolated chondral injury who underwent an accelerated return ...
Brockmeier, Stephen F, Cosgrove, Chris T, Diduch, David R, Gilmore, C. Jan, Lyons, Matthew L, Miller, Mark D, Werner, Brian C   +6 more
core   +2 more sources

Implementation of accelerated research: strategies for implementation as applied in a phase 1 Ad26.ZEBOV, MVA-BN-Filo two-dose Ebola vaccine clinical trial in Uganda

Global Health Action, 2020
Background The 2013–2016 Ebola epidemic in West Africa is the worst ever caused by Ebolaviruses with over 28,000 human cases and 11,325 deaths. The World Health Organisation (WHO) declared the epidemic a public health crisis that required accelerated ...
Jonathan Kitonsa, Abu-Baker Ggayi, Zacchaeus Anywaine, Eva Kisaakye, Laura Nsangi, Vincent Basajja, Mary Nyantaro, Deborah Watson-Jones, Georgi Shukarev, Ine Ilsbroux, Cynthia Robinson, Pontiano Kaleebu   +11 more
doaj   +1 more source

Marketing Authorisation Based on Incomplete Clinical Data: International Experience and Prospects

Регуляторные исследования и экспертиза лекарственных средств, 2020
No new drug can be used in clinical practice without marketing authorisation. Acquisition of the necessary amount of clinical data may take several years, which is especially critical for pernicious diseases for which no alternative therapy is available.
D. V. Goryachev, N. E. Uvarova, G. V. Shukshina   +2 more
doaj   +1 more source

Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017

BMJ Open, 2022
Objective To explore the associations between the risks of postmarketing safety events of new drugs and the four expedited programmes of priority review, accelerated approval, fast track and breakthrough therapy established by the US Food and Drug ...
Bao Liu, Xingyue Zhu
doaj   +1 more source

The comprehensive cohort model in a pilot trial in orthopaedic trauma [PDF]

, 2011
Background: The primary aim of this study was to provide an estimate of effect size for the functional outcome of operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using accelerated rehabilitation for ...
AM Grant, BA Salen, J Leppilahti, JA Freiman, Juul Achten, K Nilsson-Helander, K Nilsson-Helander, M Campbell, M Moller, Matthew L Costa, ML Costa, N Maffulli, Nick R Parsons, P Craig, R Brooks, R Cetti, Rebecca S Kearney, RJ Khan, S Kerry   +18 more
core   +3 more sources