tag submissions 
Fierce Pharma
MAY 14, 2024
Late Tuesday, Biogen and Eisai said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after winning a fast track tag from the agency. After suffering a setback with U.S.
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. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.
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Rethinking Clinical Trials
JUNE 29, 2022
– Could real-world data sources be certified and preclude the need for submission of source data on a study specific basis? Discussion Themes. From the FDA point-of-view, while reliability can be more readily evaluated and would tend to be more stable, the relevance to a particular study could not be determined as easily.
Rethinking Clinical Trials
MARCH 1, 2023
The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments. To reduce the burden on sites, the study has simplified data reporting by reducing time points data, reducing the number of forms that need to be submitted, and reducing the number of data elements within a form.
XTalks
NOVEMBER 3, 2022
The company is currently conducting a study to demonstrate Mounjaro’s weight loss effects and secured an FDA Fast Track tag in the obesity indication. Lilly plans to begin a rolling submission for Mounjaro in the obesity indication in 2022. Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy.
pharmaphorum
AUGUST 17, 2020
In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Joanna Carlish, managing director, financial services, Tag Americas. Virtual connections.
XTalks
APRIL 18, 2024
To help advise on new Alzheimer’s drug submissions, the FDA issued draft guidance on developing drugs for the treatment of early Alzheimer’s disease last month. Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4).
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