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accelerated approval
This page shows the latest accelerated approval news and features for those working in and with pharma, biotech and healthcare.
Novartis’ Kymriah receives FDA approval to treat follicular lymphoma
Novartis’ Kymriah has been given accelerated approval by the US Food and Drug Administration (FDA) for adult patients diagnosed with relapsed or refractory (r/r) follicular lymphoma (FL) who have had ... As part of the Accelerated Approval Programme,
Latest news
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Biogen and Eisai announce FDA submission for early Alzheimer’s treatment
The licence application for the treatment of mild cognitive impairment due to Alzheimer’s disease was made as part of the accelerated approval pathway programme. ... The submission, made as part of the accelerated approval pathway programme, is to use
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FDA grants Prothena fast-track designation for next-generation Alzheimer’s disease therapy
eligibility for accelerated approval and priority review.
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Biogen shares peer-reviewed publication of Aduhelm phase 3 data
The US Food and Drug Administration (FDA) granted Biogen accelerated approval for Aduhelm in June 2021 as the first Alzheimer’s disease treatment to address a defining pathology of the condition. ... The accelerated approval of Aduhelm was based on
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Biogen’s Alzheimer’s treatment Aduhelm limited to clinical trial participants in the US
Six months after the FDA granted Aduhelm accelerated approval, CMS has requested further evidence ahead of any payment for the drug, priced at $28, 000 a year.
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Amgen’s Lumykras receives conditional marketing authorisation from EC
The European Commission (EC) has granted conditional marketing approval for Amgen’s Lumykras/Lumakras (sotorasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the ... In May 2021, the US Food and Drug
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Mapping the patient journey: eight ways to improve support programmes
In some areas, such as gene therapies and high-cost cancer treatments, accelerated approval and early access schemes are conditional on capturing real-world outcomes data – and patient support tools provide
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How will COVID-19 affect uptake of vaccinations against other diseases?
A particular threat in this regard could come from the accelerated clinical development programmes and expedited approval processes that are being put in place to push through SARS-CoV-2 vaccines.
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Surviving cancer: a new era for patients
The FDA recently granted accelerated approval for the ADC trastuzumab-deruxtecan in patients with breast cancer, with progression-free survival (PFS) rates showing that longer life is a real possibility – a
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The Cystic Fibrosis Buyers’ Club
The movement proved to be hugely influential, and by the early 1990s its activism had spurred the FDA to introduce ‘accelerated approval’ that allowed experimental yet promising drugs to be made
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AstraZeneca: building a new ‘open innovation’ pharma company
Two of these five new launches received accelerated approval, confirming their innovative status, plus the firm also clocked up 14 other regulatory approvals across indication expan- sion and LCM projects in
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What does the future hold for Light-chain Amyloidosis?
approval in combination with CyBorD for the treatment of newly diagnosed adult patients with AL amyloidosis. ... These treatments are often approved based on single arm clinical trials via an accelerated process.
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Future focus: 3 tools for launching fast in the face of uncertainty
Numerous factors can slow down a product launch, and these barriers only become more challenging in an accelerated and rapid timeline. ... However, they are also aware that the regulatory body may not grant them accelerated or fast-track approval, and
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The future of dementia and the important role of healthcare communication in raising awareness
This allows for an accelerated approval for treatments based on biomarkers that are reasonably likely to predict clinical benefit.
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Infographic: China: How to keep up and win in the world's fastest changing healthcare market
Our latest infographic outlines the changes to the clinical trial process, accelerated drug approval, fast track of rare disease products and access opportunities in China's evolving healthcare environment.
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Parachuting Behind Enemy Lines: OncoSec’s Attack on Visceral Tumors via Its New Visceral Lesion Applicator (VLA)
Poster 717/Abstract 11375. 15. US Food and Drug Administration. Drugs. FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib. ... Accessed March 5, 2019. US Food and Drug Administration. Drugs. FDA grants accelerated
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- Bristol Myers Squibb announces positive trial results for treatment of MS
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- Eli Lilly to supply US government with 150,000 additional doses of bebtelovimab
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- A creative awakening – how pharma is bringing innovation to the patient journey
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