Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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The Pharma Data

MAY 15, 2023

Before joining Lufthansa, he served as Group CFO at Barry Callebaut based in Switzerland from 2018 through 2020. Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Prior to that, he worked in multiple executive business and finance roles for Philips and KPMG.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. In Wages and White Lion Investments (DBA Triton Distribution) v. FDA failed on each count.

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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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The Pharma Data

JULY 8, 2021

“By combining the expertise of the healthcare industry and the non-profit research community, we can carefully assess how biomedical data at this unprecedented scale is best utilized and hopefully accelerate the path from genetic discoveries towards novel therapeutics.”.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recorded a $4.7

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. The FDA action converts the 2018 accelerated approval to full approval. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S.

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Drug Discovery World

JULY 26, 2024

This, coupled with looming patent expirations, the impact of new drug pricing regulations, and tighter universal regulation of medical devices presents a complex environment for both large and small life science companies. Conversely, Trump champions free market competition and biosimilars.

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