Accelerated approval
The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases
... Since the NPV spreadsheet was designed to work in whole years, clinical trial times were averaged to the nearest whole year, rounding up at the halfway point. In order to preserve accuracy of cost prediction over rounded ...
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Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints
... the approval of the enzyme therapy agalsidase beta in a 58-patient randomized placebo-controlled ...this approval had some complications and though the result is de- bated, agalsidase beta did appear to ...
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The Value of Innovation in Oncology: Recognizing Emerging Benefits Over Time
... awarded accelerated approval for use in treating multiple myeloma (MM) patients who have received at least two prior therapies and have demonstrated disease progression on their last ...for approval, ...
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Precision medicine becomes reality—tumor type-agnostic therapy
... received accelerated approval in May 2017 by the US Food and Drug Administration for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as ...
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The discovery and development of brentuximab vedotin for use in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma
... Figure 5 Some important milestones that led to accelerated approval of brentuximab vedotin. the initial work (1998–2004) surrounded the development of the mAb (cAC10), drug (MMAE) and linker (mc-val-Cit) ...
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Role of brentuximab vedotin in the treatment of relapsed or refractory Hodgkin lymphoma
... received accelerated approval from the US Food and Drug Administration for the treatment of classical Hodgkin lymphoma that has relapsed either after autologous stem cell transplantation (ASCT) or after two ...
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Profile of brentuximab vedotin and its potential in the treatment of relapsed or refractory Hodgkin lymphoma
... These compelling clinical results led to the accelerated approval of brentuximab vedotin (Adcetris™) by the US Food and Drug Administration in 2011 for the treatment of relapsed or re[r] ...
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USEFUL APPROVAL PROCESSES
... Tip: Consider adding the Items To Approve related list to your custom home page layouts. It gives users an instant view of the approval requests they need to approve or reject. For instructions on adding this ...
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Repair Design Approval
... Since the early 1990s, Airbus sup ports the approval of repairs’ ac tions or damage allowance with a ‘Repair design Approval Sheet’ (RAS) form (See Structure Repair Manual chapter 51-11-14). From 1996, ...
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Leveraging Open Hardware to alleviate the burden of COVID-19 on global health systems
... Community and commercial open source efforts in diagnostic technology to date have focused on four areas: i) open platforms for scaling reactions as exemplified by Opentrons (Fig. 3A) [24], an open source lab automation ...
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APPROVAL AND VESTING ORDER
... THIS COURT ORDERS that for the purposes of determining the nature and priority of Claims, the net proceeds from the sale of the Purchased Assets at the Auction shall stand in the place[r] ...
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APPROVAL OF SATIVEX WITH CONDITIONS
... Conditional marketing approval was based on a four week clinical trial in patients with multiple sclerosis who had neuropathic pain of at least three months duration. There was a significant reduction in ...
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Secondary Invoice Approval
... Ensure that the GL date on the invoice header screen and the invoice line screen is amended to 31 July 20xx, prior to approval of the invoice. Do not change the GL date shown again[r] ...
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MDMA Approval Checklist
... Meter Data Management Agent Training Curriculum and Operational Procedures, including but not limited to the following: (Check all that apply) If the required information identified i[r] ...
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Final Record of Approval
... Discussion focussed on the possibility of the MSc Mobile Learning (Distance Learning) being also validated as a ‘conventional’ course alongside the distance learning, this would provide the School with the opportunity to ...
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APPROVAL AMENDMENT HISTORY
... According to the CoCT’s “Management of Urban Stormwater Impacts Policy” all stormwater management systems shall be planned and designed in accordance with best practice crit[r] ...
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Accelerated ADMM based on Accelerated Douglas-Rachford Splitting
... of accelerated gradient ...proposed accelerated Duglas-Rachford splitting by applying it on Fenchel dual problem, resulting in a method that replaces the classical proximal point convergence mechanism of ...
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Presidential Approval in Perspective
... of approval changes as more data arrive, that is, as time ...65% approval rating but steadily lost one-half percent approval each month through his first (and probably only) ...
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Twin-circumstance Data access management with capable revocation for Multi-authority cloud storage system
... another approval mystery key utilized for approval, an arrangement of approval refresh keys for non-disavowed clients furthermore, an arrangement of cipher text refresh segments for cipher text ...
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GPU based parallel acceleration for fast C-arm cone-beam CT reconstruction
... IPP accelerated FDK and an iterative TV norm regulated algebra reconstruction technique (TV-ART) algorithm, with different number of projection frames used for ...
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