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Eisai wins over European regulators on Alzheimer’s drug Leqembi

Bio Pharma Dive

But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market. A key regulatory committee sided against the drug this summer.

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Bluebird's next gene therapy gets backing from European regulator

Bio Pharma Dive

The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world.

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More federal regulators investigating Biogen's Alzheimer's drug

Bio Pharma Dive

In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes.

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Leqembi voted down by European regulators

Bio Pharma Dive

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

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Pharma under the microscope as FTC considers new ways to review acquisitions

Bio Pharma Dive

At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration. Economists and regulators also appeared worried by the effect of buyouts on innovation.

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Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Pharmaceutical Technology

According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

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The drug industry continues to dare regulation

World of DTC Marketing

The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. With over 80% of voters aligned that drug prices are too high big pharma continues to act recklessly as if to say, “we’ll do what’s best for investors and us regardless of the effects on society.”