The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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Production Clinical Trials International Small Molecule 52

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. Rare Disease. Internal Medicine. Inflammation & Immunology. Total Revenue. 42%. . . . . . Indicates calculation not meaningful.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes? 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 ).

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Regulations Pharmaceuticals Production Packaging 40

Agency IQ

MAY 31, 2024

Program Agency Deadline Survey: EU4Health Annual Work Program 2025 European Commission 6/10/2024 Survey: Real4Reg survey on real-world data Real4Reg/EMA 6/14/2024 Survey: EMA Communication perception EMA 6/21/2024 Survey: E.U. These include, but are not limited to, calls for applicants, expressions of interest and surveys.

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Regulations Production Compliance Pharmaceuticals 40

The Pharma Data

FEBRUARY 8, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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FDA Science Biosimilars Clinical Trials 40

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%

Biosimilars 78

Biosimilars Marketing Treatment Small Molecule 78

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. The Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) was caught in the crosshair once again. See Table 1.

Disease 52

Disease Vaccine Therapies FDA 52

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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Compliance FDA Regulations Production 59

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. 321(g)(1), (v).

FDA 59

FDA Production Marketing Drugs 59

FDA Law Blog: Biosimilars

MARCH 6, 2025

The inclusion criteria may include elements such as, but not limited to, the patients age, weight, height, race, ethnicity, sex, and disease severity, consistent with the intended patient population for the final product, which may not be known in the early days in the sandbox. The DCP may also define the sources of the data (e.g.,

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FDA Regulations Marketing Disease 105

FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

It was originally scheduled for Tuesday, February 18, 2025, but has recently been postponed. Comments on the Draft AI Guidance are due by April 7, 2025. A statistical analysis plan, including a plan for subgroup analysis, is also recommended to pre-specify plans to analyze validation results.

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FDA Marketing Regulations Compliance 95

FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. By Allyson B. Mullen & Jeffrey N.

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Laboratories FDA Regulations Compliance 102

FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Clissold During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco products, including most cigars and pipes, through its authority under Section 907 of the FD&C Act to adopt tobacco product standards.

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FDA Production Compliance Laboratories 66