scholarly journals Anticancer Drug Approvals in the Past Decade—Quality vs Quantity

2021 ◽  
Vol 4 (12) ◽  
pp. e2139178
Author(s):  
Rajshekhar Chakraborty
Keyword(s):  
Anticancer Drug ◽  
The Past ◽  
Drug Approvals

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 Disparities in Foundation and Federal Support and Development of New Therapeutics for Sickle Cell Disease and Cystic Fibrosis

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4687-4687 ◽  
Author(s):  
Faheem Farooq ◽  
John J Strouse
Keyword(s):  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Orphan Diseases ◽  
Cell Disease ◽  
Private Foundation ◽  
The Past ◽  
Drug Approvals ◽  
Foundation Funding

Abstract BACKGROUND: Sickle cell disease (SCD) and cystic fibrosis (CF) are rare inherited disorders of similar severity. Disparities in funding between these two diseases have been long recognized and likely contribute to limited access to care and treatments for sickle cell disease. Private investment in therapeutics for these and other orphan diseases has greatly increased in the past ten years. We hypothesized that these increased private expenditures may help correct disparities in research publications, clinical trials, and FDA approval of new therapies. METHODS: We compared funding and research output for SCD and CF between 2008-2012 versus 2013-2017. We estimated disease-specific funding using NIH Research Portfolio Online Reporting Tools and the Form 990 financial reports for foundation expenditures of multiple organizations dedicated to each disease from 2008-2016. We developed a comprehensive search strategy to identify relevant publications in PubMed and new postings of US based interventional clinical trials by disease. In addition, we reviewed FDA drug approvals and new indications for each disease from 2008-2017. RESULTS: Average annual NIH funding per affected individual was 3.4-fold greater for CF than SCD from 2008 to 2016. Between 2008-2012, private foundation funding was 161-fold greater for CF than SCD. Between 2013-2016, private funding was 971-fold greater for CF than SCD. There were 1.8 times as many PubMed publications for CF compared to SSD. There was no significant difference in PubMed publications between the two time periods. There was a significant increase in interventional clinical trials for SCD between 2013-2017, with the largest increase coming from university/philanthropic funded trials. However, CF has significantly increased FDA drug approvals of both novel compounds and novel indications. CONCLUSIONS: Although the US prevalence of SCD is three times greater than CF, the amount of federal and private foundation research funding is magnitudes greater for CF. Foundation funding for CF benefited significantly from revenue based on the successful development of targeted therapies. However, despite the significant funding difference, the number of clinical trials for SSD are comparable to CF and have increased over the past few years. Research productivity as measured by articles indexed in PubMed, and new drug approvals remain substantially higher for cystic fibrosis despite greatly increased industry investment in orphan diseases. Disclosures Strouse: Global Blood Therapeutics: Consultancy.

Novel New Drug Approvals in 2011: A Succinct Analysis of Drug Discovery Trends in the United States

2012 ◽  
Vol 5 (2) ◽  
pp. 1661-1665
Author(s):  
D Samba Reddy
Keyword(s):  
United States ◽  
Drug Discovery ◽  
Lupus Erythematosus ◽  
Lymphoblastic Leukemia ◽  
The United States ◽  
New Drugs ◽  
Chronic Obstructive ◽  
The Past ◽  
New Drug ◽  
Drug Approvals

Thirty (30) new drugs have been approved by the FDA in 2011 for marketing in the United States. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new indications for drugs already approved. Eleven of the 30 NMEs were new drugs approved for orphan diseases, while twelve are considered first-in-class drugs with a unique new mechanism of action. During 2011, the FDA approved many unique and new drugs for chronic obstructive pulmonary disease, deep vein thrombosis, systemic lupus erythematosus (SLE), and epilepsy. In addition,  several new biologicals were approved in the past year for the treatment of macular degeneration, acute lymphoblastic leukemia, Hodgkin lymphoma, melanoma, chronic hepatitis C, and SLE. The introduction of 30 NMEs in 2011 underscores a robust success rate. It confirms that innovation is once again beginning to pay off. Analysis of drug approvals reveals a unique new trend in drug discovery in the face of stiff competition from generic products and declining revenues. In the existing climate of reduced pipeline for NMEs, the future and survival of big companies rests heavily on their unique niche products and biologics with relatively less competition from generic manufacturers. However, the competition for biosimilars is growing by the hour and therefore, crafting innovative generic biologicals is vital for generic biotech companies. Although the number of NMEs approved in the past 10 years has been declining, there is a substantial increase in R&D expenditure for drug discovery. Overall, the new drug approval list unveils unique and emerging trends in drug discovery especially in the current generics era. 

Observations of the continuum near the galactic centre

1967 ◽  
Vol 31 ◽  
pp. 405
Author(s):  
F. J. Kerr
Keyword(s):  
Galactic Centre ◽  
The Past ◽  
Centre Region ◽  
The Continuum

A continuum survey of the galactic-centre region has been carried out at Parkes at 20 cm wavelength over the areal11= 355° to 5°,b11= -3° to +3° (Kerr and Sinclair 1966, 1967). This is a larger region than has been covered in such surveys in the past. The observations were done as declination scans.

The Origin of the Moon and its Relationship to the Origin of the Solar System

1962 ◽  
Vol 14 ◽  
pp. 133-148 ◽  
Author(s):  
Harold C. Urey
Keyword(s):  
Solar System ◽  
The Moon ◽  
The Past ◽  
The Earth ◽  
Short Period ◽  
Origin Of The Moon

During the last 10 years, the writer has presented evidence indicating that the Moon was captured by the Earth and that the large collisions with its surface occurred within a surprisingly short period of time. These observations have been a continuous preoccupation during the past years and some explanation that seemed physically possible and reasonably probable has been sought.

On The Possibility of an Autonomous History of Modern Southeast Asia

1961 ◽  
Vol 2 (2) ◽  
pp. 73-105 ◽  
Author(s):  
John R. W. Small
Keyword(s):  
Southeast Asia ◽  
Contemporary History ◽  
The Past ◽  
History Of

It is generally accepted that history is an element of culture and the historian a member of society, thus, in Croce's aphorism, that the only true history is contemporary history. It follows from this that when there occur great changes in the contemporary scene, there must also be great changes in historiography, that the vision not merely of the present but also of the past must change.

Stellar Evolution

1962 ◽  
Vol 11 (02) ◽  
pp. 137-143
Author(s):  
M. Schwarzschild
Keyword(s):  
Solar System ◽  
Stellar Evolution ◽  
Space Craft ◽  
New Techniques ◽  
Substantial Body ◽  
Individual Stars ◽  
The Past ◽  
Evolution Of Galaxies ◽  
History Of ◽  
Fast Flow

It is perhaps one of the most important characteristics of the past decade in astronomy that the evolution of some major classes of astronomical objects has become accessible to detailed research. The theory of the evolution of individual stars has developed into a substantial body of quantitative investigations. The evolution of galaxies, particularly of our own, has clearly become a subject for serious research. Even the history of the solar system, this close-by intriguing puzzle, may soon make the transition from being a subject of speculation to being a subject of detailed study in view of the fast flow of new data obtained with new techniques, including space-craft.

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