DNA-Damaging Cancer Therapies and FDA Novel Drug Approvals

2022 ◽  
pp. 221-238
Author(s):  
Loutfy H. Madkour
Keyword(s):  
Cancer Therapies ◽  
Drug Approvals ◽  
Novel Drug

Carbon Nanotubes as Drug Delivery Vehicles

2014 ◽  
Vol 222 ◽  
pp. 145-158 ◽  
Author(s):  
Shweta Arora ◽  
Vanish Kumar ◽  
Shriniwas Yadav ◽  
Sukhbir Singh ◽  
Deepika Bhatnagar ◽  
...  
Keyword(s):  
Carbon Nanotubes ◽  
Drug Delivery ◽  
Building Blocks ◽  
Water Soluble ◽  
Cancer Therapies ◽  
Drug Delivery Vehicles ◽  
Toxicological Profile ◽  
Drug Doses ◽  
Delivery Vehicles ◽  
Novel Drug

Various biomedical applications of nanomaterials have been proposed in the last few years leading to the emergence of a new field in diagnostics and therapeutics. Most of these applications involve the administration of nanoparticles into patients. Carbon Nanotubes are enjoying increasing popularity as building blocks for novel drug delivery systems as well as for bioimaging and biosensing. The recent strategies to functionalize carbon nanotubes have resulted in the generation of biocompatible and water-soluble carbon nanotubes that are well suited for high treatment efficacy and minimum side effects for future cancer therapies with low drug doses. The toxicological profile of such carbon nanotube systems developed as nanomedicines will have to be determined prior to any clinical studies undertaken.

When an FDA Drug Approval Makes Mainstream News: The Announcement of Zulresso, A Media Case Study

2019 ◽  
Vol 24 (4) ◽  
Author(s):  
Moira Gunn
Keyword(s):  
Financial Markets ◽  
Media Coverage ◽  
Drug Approval ◽  
Mainstream Media ◽  
Fda Approval ◽  
The Media ◽  
Drug Approvals ◽  
Novel Drug ◽  
Two Sectors

Media coverage following U.S. Food and Drug Administration (FDA) drug approvals is generally found in two sectors: bioindustry news and the financial markets. The March 19, 2019 FDA announcement of its approval of the postpartum anti-depression biopharmaceutical Zulresso from Sage Therapeutics also elicited unusually high levels of media response in the mainstream media. This case study (1) details the total media news response following the FDA approval announcement regarding Zulresso, (2) compares that media response with the mainstream media coverage for Aimovig, a Novartis and Amgen treatment, which received the most mainstream coverage in the group of 2018 FDA novel drug approvals, and (3) compares the media coverage for three recent FDA drug approvals, Mayzent, Dovato and Evenity, to demonstrate a normative media response pattern. Findings include demonstration of Zulresso coverage across all major mainstream media outlets, well in excess of its mainstream media comparator, Aimovig. The three recently-announced comparators received the anticipated media coverage in the bioindustry and financial markets segments, while the two mainstream candidates, Zulresso and Aimovig, both received more and/or more timely media coverage in the bioindustry and financial markets media sectors three recent drug approval comparators. No determination could be made as to whether the mainstream media response to Zulresso was a singular incident, or the signaling of a sea change due to the maturation of the biotechnology industry.

Postmarketing requirements for drugs approved by the Food and Drug Administration for the treatment of solid tumor cancers, 2010-2019.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13597-e13597
Author(s):  
Yolaine Jeune-Smith ◽  
Marjorie E. Zettler ◽  
Stephanie Fortier ◽  
Skyler Rupard ◽  
Ajeet Gajra ◽  
...  
Keyword(s):  
Drug Administration ◽  
Solid Tumor ◽  
Food And Drug Administration ◽  
Safety Data ◽  
Cancer Therapies ◽  
Cancer Drugs ◽  
Clinical Safety ◽  
The Past ◽  
Post Marketing ◽  
Drug Approvals

e13597 Background: In recent years, efforts to improve the efficiency and speed of drug development and approval have driven a surge of Food and Drug Administration (FDA) approvals for cancer drugs. For many cancer therapies, the serious or life-threatening nature of the condition and unmet medical need confers eligibility for expedited programs. Many cancers are also rare diseases, and the increasing use of precision medicine principles to define cancer types further contributes to smaller trial sizes. With limited clinical evidence at the time of approval, cancer drugs may be subject to a greater burden of postmarketing requirements (PMRs). We analyzed PMRs for solid tumor therapies approved by the FDA over the past decade. Methods: The FDA’s novel drug approvals (2010-2019) were reviewed to identify drugs receiving primary approval for solid tumor indications. Approval letters were accessed via the Drugs@FDA database and analyzed for PMRs required under accelerated approval (AA), the Pediatric Research Equity Act (PREA) and the FDA Amendments Act of 2007 Section 505(o) (505(o)). Data are presented using descriptive statistics. Results: A total of 60 drugs received primary approval from the FDA for solid tumor indications between 2010 and 2019 (20 [33.3%] received AA, 33 [55.0%] received orphan designation, and 45 [75.0%] received Fast Track or Breakthrough Therapy designation). The proportion of drugs receiving AA doubled between the period 2010-2014 and 2015-2019 (Table). Of the 60 drugs approved, 52 (86.7%) received a total of 180 PMRs. All 20 drugs approved under AA received PMRs, with a total of 25 PMRs issued under AA. Data from new clinical trials were required for 22 (88.0%) of the 25 PMRs. No PMRs were issued under PREA. Additional safety data required under 505(o) comprised the largest proportion of PMRs; 155 total PMRs (86.1% of all PMRs) were issued for 45 (75.0%) of the drug approvals. Pharmacokinetic or other clinical safety data were required for 96 (61.9%) of the 155 PMRs. Conclusions: More than three-quarters of the cancer drugs approved for the treatment of solid tumors in the past 10 years were issued PMRs, with the majority requiring new safety data. The results of this study indicate that PMRs represent a critical mechanism by which FDA collects safety and efficacy for solid tumor therapies, and underscore the importance of PMR fulfillment. Post-marketing requirements (PMRs) for solid tumor drugs approved 2010-2019.[Table: see text]

scholarly journals Analysis of FDA Novel Drug Approvals

2021 ◽  
Vol 14 (1) ◽  
pp. 225-233
Author(s):  
Ajay Kumar Shukla ◽  
Kumar Shukla ◽  
Rekha Mehani ◽  
Swati Jain ◽  
Sheema Maqsood
Keyword(s):  
The Novel ◽  
Medical Needs ◽  
Novel Drugs ◽  
The Us ◽  
Innovative Products ◽  
United States Food ◽  
High Predictability ◽  
States Food ◽  
Drug Approvals ◽  
Novel Drug

Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for the protection of public health by assuring that foods are safe, wholesome, sanitary and, properly labeled. Novel drug Approvals are usually innovative products to serve unmet medical needs or otherwise help to advance patient care. Methods: FDA novel drug approvals were analyzed from calendar year (CY) 2012 to 2018 based on not only their numbers but also BASED ON their impact, innovation, access, and predictability. Results: The total number of novel drugs approved from CY 2012 to 2018 was 279 (average 40 novel drugs/ year). Impact of novel drug approvals: 50% were first in class and 43% were for rare diseases. Overall expedited development and review methods were used in 63% of the novel drug approvals. Access of novel drug approvals: 84% were first-cycle approval, 74% were approved in the US before other countries, 58% priority reviews among novel drug approvals. Predictability of novel drug approvals: 98% approvals able to meet PDUFA goal dates for application review. Conclusions: Novel drug approvals during CY 2012-2018 had a high quality which is very much evident by their high impact, good access, and high predictability.

scholarly journals Novel Drug Approvals in 2015 and Thus Far in 2016

2016 ◽  
Vol 7 (9) ◽  
pp. 1175-1176 ◽  
Author(s):  
Craig W. Lindsley
Keyword(s):  
Drug Approvals ◽  
Novel Drug

scholarly journals To Discover the Efficient and Novel Drug Targets in Human Cancers Using CRISPR/Cas Screening and Databases

2021 ◽  
Vol 22 (22) ◽  
pp. 12322
Author(s):  
Iichiroh Onishi ◽  
Kouhei Yamamoto ◽  
Yuko Kinowaki ◽  
Masanobu Kitagawa ◽  
Morito Kurata
Keyword(s):  
Drug Targets ◽  
Gene Editing ◽  
Synthetic Lethality ◽  
Cancer Therapies ◽  
Human Cancers ◽  
Genetic Abnormalities ◽  
Ideal Tool ◽  
Novel Drug ◽  
Novel Drug Targets

CRISPR/Cas has emerged as an excelle nt gene-editing technology and is used worldwide for research. The CRISPR library is an ideal tool for identifying essential genes and synthetic lethality targeted for cancer therapies in human cancers. Synthetic lethality is defined as multiple genetic abnormalities that, when present individually, do not affect function or survival, but when present together, are lethal. Recently, many CRISPR libraries are available, and the latest libraries are more accurate and can be applied to few cells. However, it is easier to efficiently search for cancer targets with their own screenings by effectively using databases of CRISPR screenings, such as Depmap portal, PICKLES (Pooled In-Vitro CRISPR Knockout Library Essentiality Screens), iCSDB, Project Score database, and CRISP-view. This review will suggest recent optimal CRISPR libraries and effective databases for Novel Approaches in the Discovery and Design of Targeted Therapies.

scholarly journals An introspection of quality of novel drug approvals by United States Food and Drug Administration

2018 ◽  
Vol 8 (1) ◽  
pp. 84
Author(s):  
Rekha Mehani ◽  
Ajay K. Shukla
Keyword(s):  
United States ◽  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Medical Needs ◽  
Novel Drugs ◽  
United States Food ◽  
States Food ◽  
Drug Approvals ◽  
Novel Drug

Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance patient care.Methods: FDA novel drug approvals were analysed from calendar year (CY) 2012 to 2016 on the basis of three criteria i.e., impact, access and predictability. Impact measured on the basis of: percentage of novel drug approvals (a) first in class (b) for rare diseases. Access measured on the basis of: percentage of novel drug approvals (a) first cycle approval (b) approval in the U.S. before other countries and (c) percentage of priority reviews. Predictability measured by: the percentage of novel drug approvals that met the PDUFA goal dates for the application review.Results: Total number of novel drugs approved from CY 2012 to 2016 was 176 (average 35 novel drugs/ year). Impact of novel drug approvals: 40% were first in class and 39% were for rare diseases. Access of novel drug approvals: 84% were first cycle approval, 60% were approval in US before other countries, 51% priority reviews among novel drug approvals. Predictability of novel drug approvals: 97% approvals able to meet PDUFA goal dates for application review.Conclusions: Novel drug approvals during CY 2012-2016 had a high quality which is very much evident by their high impact, good access and high predictability.

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