2006, Licensing, Marketing and Regulations

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

FEBRUARY 21, 2023

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. Copyright © 2006-2023 Pembroke Consulting, Inc.

Pharmacy

Pharmacy Specialty Pharmacies Licensing Licensing

Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

FEBRUARY 22, 2022

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. Copyright © 2006-2022 Pembroke Consulting, Inc.

Pharmacy

Pharmacy Specialty Pharmacies Biosimilars Licensing

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Biosimilars

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

Science

Science Virus FDA Approval Treatment

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Laboratories

Laboratories FDA Regulations Licensing

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations

Regulations FDA Science Production

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Eur Respir J.

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Trials Production Clinical Trials Government

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations

Regulations Compliance Production Science

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

FDA

FDA Science Biosimilars Regulations

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. no[r] a marketing product” under Lanham Act). 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006), aff’d , 279 F. at 77 (citation omitted). In United States v.

Production

Production International Trials Government

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. Plan B, which utilizes the progestin levonorgestrel that is also used in a number of oral contraceptives, received FDA approval for over-the-counter use in 2006. Strickland , 531 F.3d

FDA Approval

FDA Approval Pharmacy FDA Drugs

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 2006), app. 2006), app. For physicians to prescribe such a safer drug, it must reach the market. 2d at 401.

FDA

FDA FDA Approval Testimonials Vaccine

Drug Discovery Digest

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

How the Fifty States View Electronic Data as a “Product”

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

The FDA and Feasible Alternative Designs

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