Results 221 to 230 of about 5,566,486 (385)

Using Dose-Escalation and -Expansion Cohort Study as Pivotal Trial for Targeted Anticancer Drug Approval. [PDF]

JCO Precis Oncol
Huang Y, Zhu T, Zhong J, Yuan J.
europepmc   +1 more source

Organizational Scope and Investment: Evidence from the Drug Development Strategies and Performance of Biopharmaceutical Firms [PDF]

This paper compares the clinical trial strategies and performance of large, established ("mature") biopharmaceutical firms to those of smaller ("early stage") firms that have not yet successfully developed a drug.
David Scharfstein, Ilan Guedj
core  

U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens [PDF]

, 2008
Ruthann M. Giusti, Kaushikkumar A. Shastri, Anne M. Pilaro, Chana Fuchs, Ruth Cordoba-Rodriguez, Kallappa M. Koti, Mark D. Rothmann, Angela Men, Hong Zhao, Monica Hughes, Patricia Keegan, Karen D. Weiss, Richard Pazdur   +12 more
openalex   +1 more source

Patient‐specific pharmacogenomics demonstrates xCT as predictive therapeutic target in colon cancer with possible implications in tumor connectivity

Molecular Oncology, EarlyView.
This study integrates transcriptomic profiling of matched tumor and healthy tissues from 32 colorectal cancer patients with functional validation in patient‐derived organoids, revealing dysregulated metabolic programs driven by overexpressed xCT (SLC7A11) and SLC3A2, identifying an oncogenic cystine/glutamate transporter signature linked to ...
Marco Strecker, Keren Zohar, Martin Böttcher, Thomas Wartmann, Henry Freudenstein, Maximilian Doelling, Mihailo Andric, Wenjie Shi, Or Kakhlon, Katrin Hippe, Beatrix Jahnke, Dimitrios Mougiakakos, Franziska Baenke, Daniel Stange, Roland S. Croner, Michal Linial, Ulf D. Kahlert   +16 more
wiley   +1 more source

Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years. [PDF]

Clin Pharmacol Ther
Mita S, Ono S.
europepmc   +1 more source

Predictors of response and rational combinations for the novel MCL‐1 inhibitor MIK665 in acute myeloid leukemia

Molecular Oncology, EarlyView.
This study characterizes the responses of primary acute myeloid leukemia (AML) patient samples to the MCL‐1 inhibitor MIK665. The results revealed that monocytic differentiation is associated with MIK665 sensitivity. Conversely, elevated ABCB1 expression is a potential biomarker of resistance to the treatment, which can be overcome by the combination ...
Joseph Saad, Rhiannon Newman, Elmira Khabusheva, Sofia Aakko, Eric Durand, Mahesh Tambe, Heikki Kuusanmäki, Alun Parsons, Juho J. Miettinen, Komal Kumar Javarappa, Ezgi June Olgac, Nemo Ikonen, Mika Kontro, Kimmo Porkka, Heiko Maacke, Janghee Woo, Ensar Halilovic, Caroline A. Heckman   +17 more
wiley   +1 more source

Predictors of orphan drug approval in the European Union [PDF]

, 2008
Harald E. Heemstra, Remco L. de Vrueh, Sonja van Weely, Hans A. Büller, Hubert G. M. Leufkens   +4 more
openalex   +1 more source

Children With Inflammatory Bowel Diseases are Disadvantaged by Current Drug Approval Policies: A Call for Urgent Change. [PDF]

Crohns Colitis 360
Sahn B, Maltz RM, Rosh JR.
europepmc   +1 more source

Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval? [PDF]

J Clin Med, 2021
Rodriguez A, Esposito F, Oliveres H, Torres F, Maurel J.   +4 more
europepmc   +1 more source

First Tissue-Agnostic Drug Approval Issued.

Cancer Discovery, 2017

semanticscholar   +1 more source