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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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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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Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen

Bio Pharma Dive

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal the verdict, a strategy successfully employed by Eisai.

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AI in Pharma Marketing: Innovation or Compliance Nightmare?

Pharma Marketing Network

Artificial intelligence (AI) is no longer a futuristic concept in healthcareits here, embedded in nearly every touchpoint of modern pharma marketing. But as pharma marketers race to adopt these tools, a central question looms: Is AI fueling smarter engagement, or setting the stage for a compliance disaster?

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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.

Marketing 306
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SEC recommends approval for MSN Laboratories’ sleep disorder drug

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.

Drugs 189