pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. In a statement, Biogen and Eisai said that the FDA has agreed that Clarity AD “can serve as the confirmatory study to verify the clinical benefit of lecanemab.”

Drugs 111

Drugs FDA Approval Trials Marketing 111

Rethinking Clinical Trials

FEBRUARY 7, 2024

Observation 3: Communication clarity, and consistency, matters. To build trust, the FDA must approach communications with an emphasis on clarity and humility. Potential strategies: “Prebunk” health misinformation; collaborate with other organizations (within and beyond government); monitor and respond to misunderstandings.

Regulation 152

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pharmaphorum

OCTOBER 21, 2021

The company’s chief executive Michel Vounatsos said he was “obviously disappointed” with the result, which he maintained resulted mainly from a lack of clarity on reimbursement which has delayed patient access. Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

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Sales Doctors Doctor Gene Therapy 122

pharmaphorum

MAY 10, 2022

As with Aduhelm (aducanumab), lecanemab is being filed via the accelerated approval pathway, with the companies seeking a green light on the strength of the results of a phase 2b trial ahead of the readout of the confirmatory Clarity AD trial, due in the autumn.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

Rethinking Clinical Trials

AUGUST 28, 2023

The new structure aims to provide clarity and better readability. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

The new structure aims to provide clarity and better readability. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. This interview has been edited for clarity and length. Currently, all approved CAR-T therapies are autologous, where T cells taken from patients are modified and then re-infused.

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Gene Therapy Gene Engineer Production 147