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priority review
This page shows the latest priority review news and features for those working in and with pharma, biotech and healthcare.
Sanofi and Regeneron receives FDA priority review for prurigo nodularis
The US Food and Drug Administration (FDA) has accepted priority review of Sanofi and Regeneron’s jointly developed Dupixent (dupilumab) to treat adults with prurigo nodularis. ... Priority reviews are granted by the FDA for therapies that could
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Genentech’s Evrysdi gets extended FDA approval for spinal muscular atrophy
Levi Garraway, Genentech’s chief medical officer and head of global product development, said: “The priority review and subsequent approval of Evrysdi for babies under two months of age [addresses] the ... Evrysdi is approved in 81 countries
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Sanofi and Regeneron receive FDA approval for eosinophilic oesophagitis treatment
The Dupixent application was assessed by the FDA under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of
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Biogen and Eisai announce FDA submission for early Alzheimer’s treatment
As part of the completed submission, Eisai has requested a priority review.
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AstraZeneca’s Imfinzi plus chemotherapy accepted for Priority Review in the US
AstraZeneca’s (AZ) has announced that its treatment, Imfinzi (durvalumab), in combination with chemotherapy, has been accepted and given a Priority Review in the US for patients with locally advanced or ... The FDA allows Priority Review applications
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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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Alzheimer’s disease: the search for a cure
We are expecting to see the outcomes of an FDA priority review of the potential Alzheimer’s drug, aducanumab, this year.
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Successful product commercialisation: what can we learn from the rare disease setting?
Rare diseases: setting the gold standard for successful product launches. A recent Deloitte Insights white paper found that three product characteristics are strongly associated with strong launch performance: priority review and ... Furthermore, a
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Cortellis Drugs to Watch in 2020 report
regulatory designations (eg, Orphan Drug, Priority Review). ... patients. The drug is under regulatory review in Japan, where a filing was submitted in July 2019.
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20 for 2020 – Five pharma companies to watch
Daiichi's partner AZ paid a massive $1.35bn upfront for rights to the drug, and after being given a priority review by the FDA as a treatment for patients with
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Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019
One Japanese Sakigake designation. One Chinese Priority Review. Interestingly, this year’s list contains no cancer drugs. ... Upadacitinib was filed for approval in the US and EU in December 2018 and accepted for US Priority Review in February 2019.
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6 critical success factors for flawless execution of a rapid first commercial launch
From clinical development to commercialization, cross‑functional team collaboration is critical when bringing a new drug to market—even more so when the product is fast‑tracked or receives priority review.
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Live Webinar: China in the fast lane: How to play and win in the world's hottest emerging market
China's key growth factors:. Fast track approvals:So far, over 180 foreign pharma products have been granted priority review and will likely hit the market within the next few years.
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A forward march for adaptive designs
This echoes strong positive signals this year from regulatory agencies, which included potential priority review status for IND applications whose clinical studies employ adaptive design. ... Companies submitting an IND application can now potentially
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