Generic Drugs Licensing Marketing Production 
XTalks
FEBRUARY 8, 2021
While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?
World of DTC Marketing
APRIL 12, 2021
The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared. In other words, money over safety.
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Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.
FDA Law Blog
MARCH 13, 2024
156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).
pharmaphorum
MARCH 16, 2022
billion of that coming from the US market, where an authorised generic sold under license from AZ has been available since early 2020. Generics of Symbicort are already available in some non-US markets, including in Europe. Symbicort brought in worldwide sales of $2.7 billion last year, with $1.1
pharmaphorum
FEBRUARY 2, 2022
Pharming has taken a step closer to getting a second product to market, after its rare disease therapy leniolisib met its objectives in a pivotal trial, setting up regulatory filings in the coming months. As it stands, the only other candidate for the disease listed in the clinicatrials.gov database is generic drug rapamycin.
Camargo
MAY 10, 2021
The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval. Drug Product. The meeting was prompted by a publication by Richard Pazdur, M.D., Indication. 7 Yes, 2 No.
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