Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Biosimilars 40

The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011.

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Science Doctors Government Compliance 40

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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Trials Production Clinical Trials Government 40

The Pharma Data

JULY 8, 2021

UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the UK. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.

Disease 52

Disease Government Clinical Trials Research 52

Agency IQ

JULY 28, 2023

A big legislative question about PAHPA Reauthorization : The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda.

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FDA Science Biosimilars Regulations 40