Results 81 to 90 of about 1,536,180 (350)

A descriptive study of new drug approvals during 2017–2021 and disease morbidity and mortality patterns in India

Perspectives in Clinical Research
Aim: Studies show the presence of a mismatch between drug research and disease burden. A study conducted in the European Union found that new drug development was restricted to certain diseases.
Urvashi Gupta, Ashwin Kamath, Priyanka Kamath   +2 more
doaj   +1 more source

Current landscape of clinical development and approval of advanced therapies

Molecular Therapy: Methods & Clinical Development, 2021
Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical ...
Carolina Iglesias-Lopez, Antonia Agustí, Antoni Vallano, Merce Obach   +3 more
doaj  

Targeted protein degradation in oncology: novel therapeutic opportunity for solid tumours?

Molecular Oncology, EarlyView.
Current anticancer therapies are limited by the occurrence of resistance and undruggability of most proteins. Targeted protein degraders are novel, promising agents that trigger the selective degradation of previously undruggable proteins through the recruitment of the ubiquitin–proteasome machinery. Their mechanism of action raises exciting challenges,
Noé Herbel, Sophie Postel‐Vinay
wiley   +1 more source

Early metastasis is characterized by Gr1+ cell dysregulation and is inhibited by immunomodulatory nanoparticles

Molecular Oncology, EarlyView.
Breast cancer metastasis is associated with myeloid cell dysregulation and the lung‐specific accumulation of tumor‐supportive Gr1+ cells. Gr1+ cells support metastasis, in part, through a CHI3L1‐mediated mechanism, which can be targeted and inhibited with cargo‐free, polymeric nanoparticles.
Jeffrey A. Ma, Sophia M. Orbach, Kate V. Griffin, Kathryn Kang, Yining Zhang, Rebecca S. Pereles, Ian A. Schrack, Guillermo Escalona, Jacqueline S. Jeruss, Lonnie D. Shea   +9 more
wiley   +1 more source

Is It Possible to Have Cheaper Drugs and Preserve the Incentive to Innovate: Reforming the Drug Approval Process According to Market Principles [PDF]

This paper argues that drugs are expensive not because of a lack of competition among research-based pharmaceutical companies, but because of a lack of competition in the drug approval process.
Corinne Sauer, Robert Sauer
core  

FDA Drug Approval: A Black and White Issue? [PDF]

, 2012
The FDA should judiciously limit the FDA approval of race-specific drugs to situations in which the utilization of racial categories is based on statistically significant scientific data and necessity and, in such cases, the meaning of race utilized ...
Yonker, Stephanie A.
core  

Cancer Drugs Approved Based on Surrogate Endpoint: A Retrospective Observational Study in the United States and China

Cancer Medicine
Background Hundreds of cancer drugs are approved globally based on surrogate endpoint response rate (RR). However, the characteristics of RR‐based approvals remain unknown.
Ting Zhu, Jinjia Zhong, Yafang Huang
doaj   +1 more source

Real-World Outcomes of Incurable Cancer Patients Treated with Unlisted Anticancer Treatments in an Academic Center in Quebec, Canada

Current Oncology
Medical oncology is a rapidly evolving field, with new medications being discovered yearly, contributing to increased survival rates. However, accessing drugs in a timely manner can be challenging. In Quebec, Canada, a physician can prescribe an unlisted
Adam Miller, Francois Panet, Victoria Korsos, Wilson H. Miller, Gerald Batist   +4 more
doaj   +1 more source

Detecting homologous recombination deficiency for breast cancer through integrative analysis of genomic data

Molecular Oncology, EarlyView.
This study develops a semi‐supervised classifier integrating multi‐genomic data (1404 training/5893 validation samples) to improve homologous recombination deficiency (HRD) detection in breast cancer. Our method demonstrates prognostic value and predicts chemotherapy/PARP inhibitor sensitivity in HRD+ tumours.
Rong Zhu, Katherine Eason, Suet‐Feung Chin, Paul A. W. Edwards, Raquel Manzano Garcia, Richard Moulange, Jia Wern Pan, Soo Hwang Teo, Sach Mukherjee, Maurizio Callari, Carlos Caldas, Stephen‐John Sammut, Oscar M. Rueda   +12 more
wiley   +1 more source

Global Regulatory Perspectives on Clinical Data Management: A Comparative Review of Various Regulatory Agencies

National Board of Examinations Journal of Medical Sciences
Background: Clinical trials are conducted with a set of ethical standards, patient safety measures, and scientific scrutiny. Clinical Data Management Systems have evolved over time, shaped by historical milestones, technological advancement, and ...
Thrupthi D L, Harshwardhan Patil, Rajath K Bharadwaj, Sameeksha K, Srikant MS   +4 more
doaj   +1 more source