Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.
Sign Up to like & getrecommendations! Published in 2022 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2022.4226
Abstract: This cohort study used the Drugs@FDA database to identify new drugs approved by the US Food and Drug Administration (FDA) and assess fulfillment of postmarket commitments and requirements. read more here.
Keywords: new drugs; fda; drugs approved; postmarket commitments ... See more keywords
Association of Research and Development Investments With Treatment Costs for New Drugs Approved From 2009 to 2018
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DOI: 10.1001/jamanetworkopen.2022.18623
Abstract: This cross-sectional study assesses the association of research and development investments based on data released by drug companies with list and net prices for prescription drugs approved by the US Food and Drug Administration from… read more here.
Keywords: association research; 2009 2018; development investments; research development ... See more keywords
Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020
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DOI: 10.1001/jamanetworkopen.2022.25973
Abstract: Key Points Question What is the overall survival benefit of cancer drugs approved in China between 2005 and 2020? Findings In this mixed-methods study comprising a systematic review and cross-sectional analysis of 78 cancer drugs… read more here.
Keywords: cancer; cancer drugs; drugs approved; approved china ... See more keywords
Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
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DOI: 10.1001/jamanetworkopen.2022.51564
Abstract: This cross-sectional study investigates the use of patient-reported outcome measures in new marketing authorizations for oncology drugs approved by the European Medicines Agency (EMA) between 2017 and 2021. read more here.
Keywords: oncology; oncology drugs; patient reported; outcome measures ... See more keywords
[Otorhinolaryngological diseases in pregnancy-which drugs are approved?]
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DOI: 10.1007/s00106-021-01144-8
Abstract: Between 1958 and 1961 approximately 10,000 children with severe deformities of extremities were born, whose mothers had taken the sedative thalidomide. Since then, drugs in pregnancy are applied with legitimate caution by the pharmaceutical industry,… read more here.
Keywords: otorhinolaryngological diseases; drugs approved; pregnancy; pregnancy drugs ... See more keywords
Repurposing of drugs approved for cardiovascular diseases: opportunity or mirage?
Sign Up to like & getrecommendations! Published in 2020 at "Biochemical pharmacology"
DOI: 10.1016/j.bcp.2020.113895
Abstract: Drug repurposing is a promising way in drug discovery to identify new therapeutic uses -different from the original medical indication- for existing drugs. It has many advantages over traditional approaches to de novo drug discovery,… read more here.
Keywords: repurposing drugs; drugs approved; cardiovascular diseases; drug ... See more keywords
Fluorine-containing drugs approved by the FDA in 2019
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DOI: 10.1016/j.cclet.2020.03.050
Abstract: Abstract Eleven new fluorine-containing FDA-approved drugs have been profiled and details of their discovery and preparation are discussed. Therapeutic areas include schizophrenia, migraine, multiple sclerosis, insomnia, rheumatoid arthritis, anti-tuberculosis, breast cancer, lymphoma kinase inhibitor, serotonin… read more here.
Keywords: containing drugs; drugs approved; fda 2019; fluorine containing ... See more keywords
Pharmacoeconomic Results Of Highly Innovative Drugs Approved For Temporary Reimbursement In The Czech Republic
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DOI: 10.1016/j.jval.2017.08.1666
Abstract: 1 Decree No. 376/2011 Coll., implementing some of provisions of the Act on Public Health Insurance. • 2 State Institute of Drug Control. Evaluation of cost-effetiveness Guidelines. 17/05/2017. • 3 Act No. 48/1997 Coll., onPpublic… read more here.
Keywords: drugs approved; results highly; approved temporary; highly innovative ... See more keywords
Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?
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DOI: 10.1111/bcp.13360
Abstract: AIMS This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim,… read more here.
Keywords: drugs approved; basis surrogate; approved basis; basis ... See more keywords
In Vitro‐to‐In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
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DOI: 10.1111/cts.12750
Abstract: A systematic analysis of the inhibition transporter data available in New Drug Applications of drugs approved by the US Food and Drug Administration (FDA) in 2018 (N = 42) was performed. In vitro‐to‐in vivo predictions… read more here.
Keywords: drugs approved; inhibition; transporter; drug ... See more keywords
Three Drugs Approved for Urothelial Carcinoma by FDA.
Sign Up to like & getrecommendations! Published in 2017 at "Cancer discovery"
DOI: 10.1158/2159-8290.cd-nb2017-071
Abstract: The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the… read more here.
Keywords: drugs approved; approved urothelial; carcinoma; carcinoma fda ... See more keywords