The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. CAPITAL ALLOCATION. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S.

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Agency IQ

OCTOBER 27, 2023

11/9/2023: Enters into force 11/9/2025: Date of application To contact the authors of this resource, please email Sierra Milam ( smilam@agencyiq.com ). To contact the editor of this resource, please email Chelsey McIntyre ( cmcintyre@agencyiq.com ).

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The Pharma Data

FEBRUARY 8, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. The ISTH guidelines suggest treatment with Cablivi ® in combination with plasma exchange and immunosuppressive therapy for first episode or relapse in all adult aTTP patients. Net sales (€ million). Libtayo ® sales in the U.S.

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Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. The ISTH guidelines suggest treatment with Cablivi ® in combination with plasma exchange and immunosuppressive therapy for first episode or relapse in all adult aTTP patients. Net sales (€ million). Libtayo ® sales in the U.S.

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Vaccine Production FDA Therapies 52

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. The changes to the EMA’s Fee Regulation (Regulation (EC) No 297/95) could be adopted during this month’s planned plenary meeting.

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Drug Patent Watch

JANUARY 13, 2025

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed.

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Marks work often deals with therapies for rare and serious diseases that face unique challenges and, therefore, require unique solutions.

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FDA Law Blog: Biosimilars

JANUARY 15, 2025

Koblitz On January 7, 2025, FDA announced that back on November 12, 2024, the Center for Veterinary Medicine (CVM) issued Warning Letters to six online retailers marketing unapproved new animal drug products that purported to treat and control seizures and epilepsy in dogs and cats. By Charles D. Snow & Sara W.

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