Agency IQ

AUGUST 16, 2024

Lykos also registered an additional open-label Phase 1 pharmacokinetics study of midomafetamine and metabolites in patients with moderate hepatic impairment to understand if a dose adjustment is necessary in that population. The study is planned to begin in 2026 and conclude in 2028.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

JULY 26, 2024

However, the “extent” of the data (comparability, CAA) will depend on the risk assessment of differences – and, in “some cases,” additional data like pharmacokinetic studies might be needed. prechange product) and the proposed biosimilar or interchangeable biosimilar with the new dosage form or strength (i.e.,

Biosimilars 40

Biosimilars Science FDA Production 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection.

FDA 40

FDA Science Biosimilars Clinical Trials 40

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Company has 89 pipeline projects spread across 6 targeted therapeutic areas with 4 programs in registration and 23 in Phase 3.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52