Development FDA Approval Generic Drugs Licensing 
Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. for patients with NTRK fusion cancer across all solid tumors.
pharmaphorum
MARCH 16, 2022
Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Generics of Symbicort are already available in some non-US markets, including in Europe.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
FEBRUARY 26, 2024
As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., mg/mL) for liquid parenteral drug products. mL) in addition to Original Concentration Humira.”
FDA Law Blog
MARCH 13, 2024
4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”
XTalks
AUGUST 2, 2023
is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc. billion.
FDA Law Blog
JULY 13, 2022
Indeed, a major complaint we highlighted last year is that the discounts negotiated for the relevant selected products—at least 60% off of the average price—could undercut generic and biosimilar manufacturer’s development programs, ultimately disincentivizing investment in generic and biosimilar development for single-source products.
Pharmacy Checkers
DECEMBER 12, 2019
The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system.
Expert insights. Personalized for you.
242 
Let's personalize your content