Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).
Pharma in Brief
JANUARY 10, 2024
However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.
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FDA Law Blog
FEBRUARY 29, 2024
156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. § That did not happen.
The Pharma Data
NOVEMBER 21, 2020
Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Hahn , M.D.
XTalks
FEBRUARY 8, 2021
They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. The regulator allows biosimilars to show slight differences in clinically inactive components of a product. What is a Biosimilar?
The Pharma Data
FEBRUARY 13, 2022
Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks.
The Pharma Data
APRIL 18, 2022
The draft guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are capable of triggering anaphylaxis and are considered the most severe and immediately life-threatening food allergies. Reactions to some non-listed food allergens have relatively low prevalence rates, with some as low as single cases.
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