The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Klisyri is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex. “The

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

Drug Target Review

MAY 15, 2024

3 The value required is more than just a greater number of FDA approvals, it is also about completing milestones with limited capital – ie, biotech survival. The latter group (ie, most of us) are waiting for wet lab validation, market demonstration (FDA approvals), and a few other things (which we often cannot define).

FDA Approval 59

FDA Approval FDA Science Marketing 59

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. 2003) , and Biogen lnt’l v. Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. §

FDA Approval 57

FDA Approval FDA Production Therapies 57

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

FDA 104

FDA Biosimilars Drugs FDA Approval 104

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The CHPA presenters described “issues and misconceptions” with the FDA analysis. billion, compared with retail sales of $0.5

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Codon

NOVEMBER 1, 2024

A first draft was published in 2003; it was a patchwork of sequenced DNA from multiple people. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. Department of Energy and National Institutes of Health initiated a 15-year plan to map ‘the sequence of all 3.2

DNA 105

DNA RNA Molecular Biology Laboratories 105