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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.
Merck, Eisai’s Keytruda/Lenvima regimen scores full approval in endometrial cancer
Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process. ... The Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process for the treatment of certain endometrial cancer patients.
Latest news
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FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm
Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway. ... the CDER, wrote the article to explain the rationale for the FDA’s decision to grant Aduhelm (aducanumab) an accelerated approval.
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FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval
Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company. ... The FDA granted Aduhelm an accelerated approval, meaning that a confirmatory study is needed to ensure the drug can continue to be
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FDA narrows label for Biogen’s Aduhelm to only include mild forms of Alzheimer’s disease
The FDA approved Aduhelm via its accelerated approval pathway, which requires Biogen to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit for Alzheimer’s patients. ... Following its surprise approval in June,
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Merck & Co withdraws Keytruda’s US approval in third-line stomach cancer
Merck &Co has announced that it will voluntarily withdraw a US Food and Drug Administration (FDA) accelerated approval for Keytruda in third-line stomach cancer. ... In a statement, Merck &Co – known as MSD outside the US and Canada – said that it
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Fool’s gold or pot of gold? The challenges of demonstrating the value of tumour agnostic therapies
To date, Vitrakvi (larotrectinib) &Rozlytrek (entrectinib) are the only ‘pure’ TA products to receive conditional EMA approval and accelerated FDA approval for NTRK positive tumours. ... How to demonstrate value to regulators and payers? In order to
FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm
FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval
FDA narrows label for Biogen’s Aduhelm to only include mild forms of Alzheimer’s disease
Merck & Co withdraws Keytruda’s US approval in third-line stomach cancer
Fool’s gold or pot of gold? The challenges of demonstrating the value of tumour agnostic therapies
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Approximately 7 fully matching, plus 160 partially matching documents found.
Latest Intelligence
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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
Mapping the patient journey: eight ways to improve support programmes
How will COVID-19 affect uptake of vaccinations against other diseases?
Surviving cancer: a new era for patients
The Cystic Fibrosis Buyers’ Club
AstraZeneca: building a new ‘open innovation’ pharma company
More from intelligence
Approximately 0 fully matching, plus 11 partially matching documents found.
Latest from PMHub
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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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A stumble, but not a fall – what’s next for Opdivo?
The immuno-oncology treatment won an accelerated FDA approval for metastatic melanoma in December 2014, and has since proved to be a thriving sensation. ... Rubbing salt into BMS’s wounds, Merck's Keytruda snagged a new FDA approval in
The future of dementia and the important role of healthcare communication in raising awareness
More from PMHub
Approximately 0 fully matching, plus 4 partially matching documents found.
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- One dose of AZ’s COVID-19 vaccine ‘highly effective’ against severe disease from variants
- AZ publishes new real-world safety data for COVID-19 vaccine Vaxzevria
- Mixing AZ and Pfizer COVID-19 vaccines increases antibody levels
- Understanding the ‘real world’ starts and ends with the patient
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- Biogen and Eisai present new data for controversial Alzheimer's drug Aduhelm at AAIC
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