Results 141 to 150 of about 1,710,685 (294)

DRUG LAG FOR ANTIMICROBIAL AGENTS: COMPARISON OF THE US, EU AND INDIA APPROVALS

National Journal of Medical Research, 2012
Background: Antimicrobial resistance is a global problem and the need for new antimicrobial agents is greater in both developed and developing nations.
Bhaven C Kataria, Dimple S Mehta , Sanjay J Mehta   +2 more
doaj  

Regulatory Disparities Between US Accelerated Approval and Japanese Authorization of Oncology Drugs: An Analysis of Evidence Quality

Clinical and Translational Science
While the accelerated approval (AA) program in the United States expedites the availability of drugs based on preliminary evidence to fulfill unmet medical needs, it has also raised significant concerns, including a lack of robust evidence of efficacy ...
Maho Iwata, Anju Murayama
doaj   +1 more source

Drug approval prediction based on the discrepancy in gene perturbation effects between cells and humans. [PDF]

EBioMedicine, 2023
Park M, Kim D, Kim I, Im SH, Kim S.
europepmc   +1 more source

Combining antibody conjugates with cytotoxic and immune‐stimulating payloads maximizes anti‐cancer activity

Molecular Oncology, EarlyView.
Methods to improve antibody–drug conjugate (ADC) treatment durability in cancer therapy are needed. We utilized ADCs and immune‐stimulating antibody conjugates (ISACs), which are made from two non‐competitive antibodies, to enhance the entry of toxic payloads into cancer cells and deliver immunostimulatory agents into immune cells.
Tiexin Wang, Dong Jun Koo, Peter M. Tessier, Greg M. Thurber   +3 more
wiley   +1 more source

Dostarlimab: From preclinical investigation to drug approval and future directions. [PDF]

Hum Vaccin Immunother, 2023
Cicala CM, Musacchio L, Scambia G, Lorusso D.   +3 more
europepmc   +1 more source

TRAIL‐PEG‐Apt‐PLGA nanosystem as an aptamer‐targeted drug delivery system potential for triple‐negative breast cancer therapy using in vivo mouse model

Molecular Oncology, EarlyView.
Aptamers are used both therapeutically and as targeting agents in cancer treatment. We developed an aptamer‐targeted PLGA–TRAIL nanosystem that exhibited superior therapeutic efficacy in NOD/SCID breast cancer models. This nanosystem represents a novel biotechnological drug candidate for suppressing resistance development in breast cancer.
Gulen Melike Demirbolat, Aslihan Kucuk, Omer Erdogan, Samed Ozer, Bensu Kozan, Tugba Cuceli, Erkan Gumus, Evrim Cevik, Ozge Cevik   +8 more
wiley   +1 more source

Predictors of orphan drug approval

Orphanet Journal of Rare Diseases, 2010
Heemstra Harald
doaj   +1 more source

FDA Drug Approval and the Ethics of Desperation. [PDF]

JAMA Intern Med, 2021
Largent EA, Peterson A, Lynch HF.
europepmc   +1 more source

The PI3Kδ inhibitor roginolisib (IOA‐244) preserves T‐cell function and activity

Molecular Oncology, EarlyView.
Identification of novel PI3K inhibitors with limited immune‐related adverse effects is highly sought after. We found that roginolisib and idelalisib inhibit chronic lymphocytic leukemia (CLL) cells and Treg suppressive functions to similar extents, but roginolisib affects cytotoxic T‐cell function and promotion of pro‐inflammatory T helper subsets to a
Elise Solli, Alessio Bevilacqua, Mathias Wenes, Denis Migliorini, Lars van der Veen, Sigrid S Skånland, Giusy Di Conza, Kjetil Taskén   +7 more
wiley   +1 more source

Implications of Evolving Disease Classification for Drug Approval in Juvenile Idiopathic Arthritis. [PDF]

Paediatr Drugs, 2022
Case SM, Nigrovic PA.
europepmc   +1 more source