Advertisement

Topics

2017 in review: FDA approvals of new molecular entities.

08:00 EDT 8th May 2018 | BioPortfolio

Summary of "2017 in review: FDA approvals of new molecular entities."

An overview of drugs approved by the FDA in 2017 reflected a reversion to the mean after a low number of NME approvals in 2016. This reversal was largely driven by the largest number of biologics-based NMEs recorded to date, which offset an average number of small-molecule approvals. Oncology indications continued to dominate followed by novel treatments for infectious, immunologic and neurologic diseases. From a mechanistic standpoint, the industry has continued a trend of target diversification, reflecting advances in scientific understanding of disease processes. Finally, 2017 continued a period of relatively few mergers and acquisitions, which broke a more-than-a-decade-long decline in the number of organizations contributing to research and development.

Affiliation

Journal Details

This article was published in the following journal.

Name: Drug discovery today
ISSN: 1878-5832
Pages:

Links

DeepDyve research library

PubMed Articles [21132 Associated PubMed Articles listed on BioPortfolio]

2017 is Banner Year for Drug Approvals by the FDA.

In 2017, the US Food and Drug Administration approved 46 novel drugs and 29 drugs received newly approved indications. This record setting year was due in part to the new expedited review pathways. A ...

Diagnostically relevant updates to the 2017 WHO classification of lymphoid neoplasms.

The recent 2017 WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues contains a number of updates under the category of lymphoid neoplasms. These changes include introduction of new en...

Synthetic Approaches to New Drugs Approved During 2016.

New drugs introduced to the market every year represent privileged structures for particular biological targets. These new chemical entities (NCEs) provide insight into molecular recognition while ser...

Innovation and trends in the development and approval of antiviral medicines: 1987-2017 and beyond.

2017 marked the 30th anniversary of the approval of zidovudine (AZT) as the first HIV/AIDS therapy. Since then, more than eighty antiviral drugs have received FDA approval, half of which treat HIV inf...

Highlights from 2017: impactful topics published in the Annals of Nuclear Medicine.

The aim of the review is to highlight articles published in 2017 in the Annals of Nuclear Medicine, an official peer-reviewed journal of the Japanese Society of Nuclear Medicine. Among all published m...

Clinical Trials [2818 Associated Clinical Trials listed on BioPortfolio]

Clinical Study of OncoSorb® in Patients With Advanced Cancer Entities

The purpose of this study is to collect further data for safety and feasibility for the use of the medical device OncoSorb® in clinical routine for the treatment of patients with solid me...

Effect of Strength Training for Chronic Low Back Pain Patients

Low back pain (LBP) is common in the population and has great socioeconomic consequences for societies across Europe and the United States. About a third of working-age adults have frequen...

Prevalence of Acute-On-Chronic Liver Failure in Zagazig University Hospitals

Rationale: To identify the prevalence of Acute-on-chronic liver failure in Zagazig University Hospitals. The question of the research: How much the prevalence of Acute-on-ch...

Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer: Role in Clinical Management and Primary Site Prediction

This will be a retrospective review of 30 patients with unknown primary cancer who have had commercially available RT-PCR assays performed on biopsied tumors, in order to determine if the ...

Multi-center Study on Children's and Adolescents' Medulloblastoma Molecular Subgroups in China

Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before since the new World Health Organization (WHO) diagnosis criteria has put molecular marker onto a...

Medical and Biotech [MESH] Definitions

Review of the medical necessity of hospital or other health facility admissions, upon or within a short time following an admission, and periodic review of services provided during the course of treatment.

Formal programs for assessing drug prescription against some standard. Drug utilization review may consider clinical appropriateness, cost effectiveness, and, in some cases, outcomes. Review is usually retrospective, but some analysis may be done before drugs are dispensed (as in computer systems which advise physicians when prescriptions are entered). Drug utilization review is mandated for Medicaid programs beginning in 1993.

Organizations representing designated geographic areas which have contracts under the PRO program to review the medical necessity, appropriateness, quality, and cost-effectiveness of care received by Medicare beneficiaries. Peer Review Improvement Act, PL 97-248, 1982.

The reaction of two molecular entities via oxidation usually catalyzed by a transition metal compound and involving dioxygen as the oxidant.

Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analyses of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form.

Advertisement
Quick Search
Advertisement
Advertisement

 


DeepDyve research library

Relevant Topics

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...

Biotherapeutics
The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...


Searches Linking to this Article