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accelerated review
This page shows the latest accelerated review news and features for those working in and with pharma, biotech and healthcare.
Biogen and Eisai’s Alzheimer’s drug shown to slow memory decline in confirmatory study
The US Food and Drug Administration accepted Eisai’s Biologics Licence Application for lecanemab under the accelerated approval pathway and granted Priority Review in July 2022, and agreed that the results
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Biogen and Eisai’s lecanemab shows promise in confirmatory Alzheimer’s study
The US Food and Drug Administration (FDA) accepted Eisai’s Biologics Licence Application for lecanemab under the accelerated approval pathway and granted Priority Review in July 2022, setting a Prescription Drugs
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EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate
The EMA launched its PRIME scheme to enhance support and enable accelerated assessment for the development of medicines that target an unmet medical need. ... Bavarian Nordic’s president and CEO Paul Chaplin, said: “…We are proud to receive
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FDA grants Prothena fast-track designation for next-generation Alzheimer’s disease therapy
The fast-track programme is designed to accelerate the development and review of drugs intended to treat serious conditions, by incorporating compelling evidence which demonstrates the potential to address unmet medical ... eligibility for accelerated
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FDA issues final guidances for clinical cancer trials
The first guidance, Inclusion of Older Adults in Cancer Clinical Trials, gives recommendations to sponsors and institutional review panels for including patients aged 65 and older in clinical trials for cancer ... what sponsors should submit to the FDA
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Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm
We are concerned by apparent anomalies in FDA’s processes surrounding its review of Aduhelm. ... PCNS advisory committee) – about the drug’s clinical benefit and the use of the accelerated approval pathway for Aduhelm.”.
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China: AstraZeneca’s new engine for growth and innovation
In March 2017, AZ’s targeted lung cancer drug Tagrisso was one of the first medicines to gain approval through the Chinese Food and Drug Administration (CFDA)’s Priority Review pathway, ... Roxadustat is under accelerated review and, if approved,
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Uncertainty, austerity and Brexit
Alongside this, rumours that NHS England was planning to include biosimilars on the Accelerated Access Pathway, the flagship policy intervention designed to speed up the use of innovative products, would amount ... Sciences Industrial Strategy and the
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Working with our healthcare system more closely is vital
Specifically, this should include building on the recommendations put forward in the Life Science Industrial Strategy and the Accelerated Access Review, to streamline access evaluation processes for new therapies and enable
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Macron, Merkel and May: implications of the 2017 elections for the life science industry
Furthermore, the 2017 Conservative Party election manifesto promised to ‘implement the findings of the Accelerated Access Review to make sure that patients get new drugs and treatments faster while the NHS
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Europe vs the US: New drug product approvals
Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common. ... In 2016 special approval pathways and designations like Fast Track, Breakthrough, Accelerated
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Aurora celebrates 15 years of improving lives
Worked to speed up access to innovative medicines and technologies, including contributing to the UK Government’s Accelerated Access Review.
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- Contagious Conversations: Exploring Infectious Disease in the Digital Age
- Austrian State Secretary to speak at FlyPharma Europe 2023
- Further data for AstraZeneca/Daichii Sankyo’s Enhertu for breast cancer requested by NICE
- Gritstone Bio receives $433m BARDA contract for COVID-19 vaccine candidate
- EDX Medical Group develops multi-disease 'point-of-care' rapid tests for cancer, infections and cardiovascular conditions
- ScreenPoint Medical to showcase AI software at European scientific meeting
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We live in a hyper-connected world. This has clear benefits for the health of our communities, our businesses and our...
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- There are many informed, knowledgeable HCPs who talk about a disease state online, but not all of them are influencers. This paper explores who digital opinion leaders are and how...
- Creating Hope Though Action – World Suicide Prevention Day
- At Mednet Group, we believe that actions speak louder than words. That's why we're getting behind this year's Suicide Prevention Day campaign of 'creating hope through action'....
