Results 71 to 80 of about 1,536,180 (350)

Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU

Clinical and Translational Science, 2023
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug ...
Ebru Demirci, Grace Omes‐Smit, Alex Zwiers   +2 more
doaj   +1 more source

Targeting the AKT/mTOR pathway attenuates the metastatic potential of colorectal carcinoma circulating tumor cells in a murine xenotransplantation model

Molecular Oncology, EarlyView.
Dual targeting of AKT and mTOR using MK2206 and RAD001 reduces tumor burden in an intracardiac colon cancer circulating tumor cell xenotransplantation model. Analysis of AKT isoform‐specific knockdowns in CTC‐MCC‐41 reveals differentially regulated proteins and phospho‐proteins by liquid chromatography coupled mass spectrometry. Circulating tumor cells
Daniel J. Smit, Thais Pereira‐Veiga, Helena Brauer, Michael Horn, Paula Nissen, Thomas Mair, Bente Siebels, Hannah Voß, Ruimeng Zhuang, Marie‐Therese Haider, Desiree Loreth, Margarita Iskhakova, Bele Lindemann, Julian Kött, Laure Cayrefourcq, Jasmin Wellbrock, Hartmut Schlüter, Klaus Pantel, Catherine Alix‐Panabières, Manfred Jücker   +19 more
wiley   +1 more source

REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY [PDF]

, 2016
Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature.
Darzi, A, Hughes-Hallett, A, Marcus, AP, Marcus, HJ, Nandi, D, Payne, CJ, Yang, GZ   +6 more
core   +2 more sources

Assessment of the implementation of accelerated drug marketing registration procedures for antineoplastic and immunomodulating agents in China: based on 2016–2022 review data

Frontiers in Pharmacology
Objective:Since 2016, China has successively implemented Accelerated Drug Marketing Registration Procedures (ADMRPs) for drugs, including Breakthrough Therapy Drug (BTD), Conditional Approval (CA), and Priority Review and Approval (PRA), which have ...
Yipeng Lan, Xiaofeng Lin, Jialin Yu, Li Wang, Lihua Sun, Lihua Sun, Zhe Huang, Zhe Huang   +7 more
doaj   +1 more source

MET and NF2 alterations confer primary and early resistance to first‐line alectinib treatment in ALK‐positive non‐small‐cell lung cancer

Molecular Oncology, EarlyView.
Alectinib resistance in ALK+ NSCLC depends on treatment sequence and EML4‐ALK variants. Variant 1 exhibited off‐target resistance after first‐line treatment, while variant 3 and later lines favored on‐target mutations. Early resistance involved off‐target alterations, like MET and NF2, while on‐target mutations emerged with prolonged therapy.
Jie Hu, Ning Ding, Xiaobo Xu, Yedan Chen, Yong Zhang, Jingwen Liu, Jiebai Zhou, Hairong Bao, Donghui Zhang, Yijun Song, Yang Shao, Yuanlin Song   +11 more
wiley   +1 more source

Maraviroc: integration of a new antiretroviral drug class into clinical practice [PDF]

, 2008
Maraviroc (Pfizer's UK-427857, Selzentry or Celsentri outside the US) is the first agent in the new class of oral HIV-1 entry inhibitors to acquire FDA and EMEA approval.
Vandekerckhove, Linos, Verhofstede, Chris, Vogelaers, Dirk   +2 more
core   +2 more sources

An empirical analysis of overall survival in drug approvals by the US FDA (2006–2023)

Cancer Medicine
Background The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster ...
Josh Elbaz, Alyson Haslam, Vinay Prasad
doaj   +1 more source

Chemoresistome mapping in individual breast cancer patients unravels diversity in dynamic transcriptional adaptation

Molecular Oncology, EarlyView.
This study used longitudinal transcriptomics and gene‐pattern classification to uncover patient‐specific mechanisms of chemotherapy resistance in breast cancer. Findings reveal preexisting drug‐tolerant states in primary tumors and diverse gene rewiring patterns across patients, converging on a few dysregulated functional modules. Despite receiving the
Maya Dadiani, Gilgi Friedlander, Gili Perry, Nora Balint‐Lahat, Shlomit Gilad, Dana Morzaev‐Sulzbach, Anjana Shenoy, Noa Bossel Ben‐Moshe, Anya Pavlovsky, Rinat Bernstein‐Molho, Eytan Domany, Iris Barshack, Tamar Geiger, Bella Kaufman, Einav Nili Gal‐Yam   +14 more
wiley   +1 more source

FDA Approval of Drugs and Devices: Preemption of State Laws for “Parallel” Tort Claims [PDF]

, 2015
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from ...
Boumil, Marcia
core  

Spotlight on ixazomib: Potential in the treatment of multiple myeloma [PDF]

, 2016
Despite the significant therapeutic advances achieved with proteasome inhibitors (PIs) such as bortezomib and carfilzomib in prolonging the survival of patients with multiple myeloma, the development of drug resistance, peripheral neuropathy, and ...
Azab, Abdel K, Ghazarian, Rachel N, Kusdono, Hubert D, Luderer, Micha J, Muz, Barbara, Ou, Monica   +5 more
core   +2 more sources