The Pharma Data

NOVEMBER 4, 2020

Total Revenue Increased 39% in Third Quarter 2020 and 56% in First Nine Months of 2020 Compared toSame Periods of 2019 Despite COVID-19 Headwinds. Progress Continues Towards VASCEPA® (icosapent ethyl) Approval and Commercialization in Europe. million, an increase of 56% compared to the same period in 2019.

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Production FDA Trials Licensing 40

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

Treatment 40

Treatment FDA FDA Approval Therapies 40

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

FDA Approval 40

FDA Approval Treatment FDA Therapies 40

The Pharma Data

MAY 4, 2021

up 28%, primarily driven by continued strong demand in the metastatic and non-metastatic castration-resistant prostate cancer indications, as well as the metastatic castration-sensitive prostate cancer indication, which was approved in the U.S. in December 2019; and. 7) BNT162b2 has not been approved or licensed by the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

Drug & Device Law

MARCH 22, 2022

The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. Therefore, plaintiff’s failure to warn claim is preempted unless “she has pleaded a labeling deficiency that [defendant] cold have unilaterally changed in accordance with the requirements of the CBE regulation.”

Vaccine 59

Vaccine Production FDA FDA Approval 59

Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. We were hardly alone. & Man’l Epid’y. Studnicki J., Longbons T.,

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

APRIL 20, 2023

This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions. The identified injuries were even more unusual in light of the lack of standing to challenge approval. That is unusual.

FDA 59

FDA FDA Approval Doctors Treatment 59

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. The disputed regulations ostensibly regulated how health care providers and pharmacists could prescribe and/or dispense the targeted drug. 2022 WL 2276808 (U.S.

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