Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers. Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

Pharmacy 96

Pharmacy Specialty Pharmacies Biosimilars Licensing 96

FDA Law Blog: Biosimilars

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. What is noteworthy about this proposed definition is that it adds a new requirement that “[a] manufacturer must make data available to CMS to support its finding.”

Drugs 59

Drugs Regulations Government Vaccine 59

The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. Definition of High-Risk Patients. . “COVID-19 continues to sicken hundreds of thousands of Americans every day and the people of Regeneron are committed to help,” said Leonard S. Schleifer , M.D.,

Government 52

Government Hospitals Virus Production 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. covered insulin product or vaccine).

Compliance 105

Compliance Pharmacy Drugs Licensing 105

The Pharma Data

NOVEMBER 20, 2020

We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Definition of High-Risk Patients. Have chronic kidney disease. Are ?

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

NOVEMBER 21, 2020

We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Definition of High-Risk Patients. Have chronic kidney disease. Have diabetes.

FDA 40

FDA Clinical Trials Hospitals Government 40

Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59