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1 knowledge into potential medicines, known as orphan drugs.
2 c and immunomodulating drugs, biologics, and orphan drugs.
3 g the 14-year study period; 252 (43.4%) were orphan drugs, 139 (23.9%) were therapeutic biologics, an
4 ; special development and approval programs (Orphan drug [1984-2018], Fast-Track [1988-2018], Priorit
5 t at least 1 rare disease, including 25 sole orphan drugs (26%), 20 multiorphan drugs (21%), 13 orpha
6     The proportion of drugs approved with an Orphan Drug Act designation increased from 18% (55/304)
7 /y) in any year from 2012 to 2021 and had an Orphan Drug Act designation.
8                Since the introduction of the Orphan Drug Act in 1983, designed to promote development
9                                          The Orphan Drug Act incentivizes medication development for
10 e leveraged the incentivized benefits of the Orphan Drug Act to develop more of these drugs for orpha
11 through expedited regulatory pathways or the Orphan Drug Act.
12                      ATH434 has been granted Orphan drug and Fast Track designation by the FDA.
13 NMEs and for 73% of non-orphan versus 45% of orphan drug approvals.
14 een effective as evidenced by an increase in orphan drugs as well as antibacterial drugs approved und
15  least 1 expedited program, 225 (62.0%) were orphan drugs; at least 1 expedited program was used by 9
16    First-in-class (FIC) drugs and drugs with Orphan Drug Designation (ODD) have a higher frequency of
17 n addition, other incentive programs such as Orphan Drug Designation (ODD), Qualified Infectious Dise
18                  VT3989 was recently awarded orphan drug designation and fast-track designation for t
19                      The EMA has granted the Orphan Drug Designation to this product, underscoring th
20  grouped by product category, review status, orphan-drug designation and therapeutic indication, and
21 igh share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that
22 decades there has been increased interest in orphan drug development for rare diseases.
23                                           As orphan drug development grows, demand will likely increa
24                                              Orphan drug development is a rapidly expanding field.
25  function, we investigated the effect of the orphan drug dichloroacetate (DCA) on survival in an anim
26 The primary outcomes were the number of sole orphan drugs, estimated Medicare spending on those drugs
27  drugs, pivotal trials for recently approved orphan drugs for cancer were more likely to be smaller a
28 US Food and Drug Administration has approved orphan drugs for neurological diseases without randomize
29                               The concept of orphan drugs for treatment of orphan genetic diseases is
30 bitor that has been recently approved as an 'orphan drug' for the treatment of patients with unresect
31                            Pivotal trials of orphan drugs had smaller participant numbers (median, 96
32 f treatments for rare diseases, at least 378 orphan drugs have been approved.
33                               We created the orphan drug Human Botulism Immune Globulin Intravenous (
34 From 2012 to 2021, Medicare spending on sole orphan drugs increased from $3.4 billion to $10.0 billio
35 s for AA for oncology NMEs, particularly for orphan drug indications, may facilitate timely FDA appro
36 y to be completed for orphan drug versus non-orphan drug indications.
37 sing, perhaps as a result of the increase in orphan drug indications.
38 a previously FDA-approved active moiety, and orphan drugs, intended for diseases or conditions affect
39 tion is the target of the recently approved 'orphan drug', ivacaftor.
40 First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieve
41 manent with special incentives for pediatric orphan drug-product development.
42 ta were mainly accessible for smaller firms, orphan drugs, products in certain therapeutic areas, fir
43 rug discovery offering a promising venue for orphan drug research.
44 used and in what combinations, stratified by orphan drug status and drug type (small molecule vs ther
45 rials respectively and NeuroSTAT(R) received orphan drug status from US FDA and Europe in 2010.
46                          We reviewed data on orphan drug status, development time, safety, and status
47 e a different expedited program or differ in orphan drug status.
48 for amebiasis, and the drug has been granted orphan-drug status from the FDA.
49 f recently approved, novel, mutation guided 'orphan drug' therapies that have established clinical be
50 re nine-fold less likely to be completed for orphan drug versus non-orphan drug indications.
51 ents had serious adverse events in trials of orphan drugs vs trials of nonorphan drugs (48% vs 36%; o
52 tive global revenue of the median (IQR) sole orphan drug was $11 ($6.6-$19.2) billion.