The FDA Law Blog

JANUARY 29, 2025

With oversight over FDA, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and the Centers for Disease Control and Prevention, Kennedys portfolio will be vast. We dont know if the hearings will get even ankle deep into the actual management of FDA. Kennedy, Jr.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

It will expire on 24 November 2026, and the paediatric exclusivity lasts until 24 May 2027. Viatris is seeking approval from the US Food and Drug Administration (FDA) to market Januvia and Janumet’s generic versions in the country. The suit involved two Merck patents. The first is for the dihydrogen phosphate salt of sitagliptin.

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European Pharmaceutical Review

MARCH 4, 2024

These biopharmaceuticals encompass a range of products including vaccines, recombinant therapeutic proteins, tissues, cells and gene therapies – all sourced from living organisms. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Difficile at the end of November 2022, but in 2023 they will be joined by Seres, which expects an FDA decision in April 2023 on its C.

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pharmaphorum

DECEMBER 10, 2020

Shares in the big US pharma were up nearly 6% following the announcement, although the pharma stocks in general were buoyed by optimism over BioNTech/Pfizer’s COVID-19 vaccine. Tirzepatide is also taken weekly, cutting the number of injections needed to control blood sugar.

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pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Guest FDA Speaker: John Barr Weiner, Associate Director for Policy and Product Classification Office, Office of Combination Products FDA. . The global pre-filled syringes market was valued at $1139.6

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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