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As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. But these immunotherapies also come with various potentially dangerous side effects. |

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Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug

Fierce Pharma

After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. But at least two experts remain positive about the drug’s efficacy and safety profile.

Doctors 196
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Another reason change is needed at FDA? Fair balance

World of DTC Marketing

Safety pages on Pharma product websites continue to have high utility. To portray patients, mindless people who blindly believe DTC TV ads and rush to their doctor to ask for a product are inaccurate. If the FDA understood consumer behavior like marketers instead of scientists, they would understand how DTC works.

FDA 165
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The debate on DTC marketing is going to heat up again

World of DTC Marketing

The FDA needs to study what people do when they see a DTC ad. Today, people don’t see a DTC TV ad and run to their doctor to ask for an Rx. 3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.”

Marketing 285
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A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

FDA 207
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Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

Patients 200
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Is DTC effective?

World of DTC Marketing

The old belief is that patients who are interested in new treatments ask their doctor about them. The FDA can be myopic when researching how consumers view and react to DTC. They’re going to go online where they can read the safety warnings that too often than not scare them because they lack context.