FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively. Phase-Ins : To ease the transition to 10% and 20% discounts, the IRA has two phase-in programs for certain manufacturers. had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

SEPTEMBER 7, 2021

3.375% Notes due 2029. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. 360,745,000. 1.750% due August 15, 2041.

Licensing 52

Licensing Licensing Marketing 52

Codon

FEBRUARY 23, 2025

million new HIV infections by 2029, undermining progress toward the UN’s goal. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. All the participants in the study received PrEP because it would have been unethical to deprive them of an existing, licensed preventative.

Clinical Trials 68

Clinical Trials Virus Vaccine DNA 68