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US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes

Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

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The Serious Business Of Digital Medical Games

There are fewer than a handful of approved prescription video game digital therapeutics, but gamification in patient care is proving its worth as a novel way of treating a range of conditions, from vision loss to dyslexia and ADHD. Now, the onus is on lawmakers and insurers to create a clear path towards reimbursement.

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New Deals, Modalities In Sights In Japan After Relatively Quiet 2022

After a comparatively subdued 2022 in terms of M&A and other deal-making, a strengthening currency and interest in new areas such as digital tools and cell and gene therapy might see a rebound in activity this year, which should also see domestic approvals of several potential blockbusters and more support for bioventures.

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Ipsens Onivyde Pancreatic Cancer Trial Survival Disappointment Dashes Sales Boost Hopes

The French firm unveiled data from its pancreatic cancer trial showing Onivyde plus chemotherapy improved median PFS by just over a month compared with current treatment of choice but failed to beat its overall survival benchmark.

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