FDA Law Blog: Biosimilars

JULY 24, 2023

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027.

FDA 52

FDA Regulations Clinical Trials Drugs 52

Drug Target Review

JUNE 5, 2023

How does Zymeworks plan to advance at least five novel medicines into clinical studies by 2027 under its ZYME 5×5 R&D objectives? His career efforts have led to the discovery and development of a range of FDA-approved and clinical-stage biologics for patients with difficult-to-treat cancers and autoimmune conditions.

Treatment 100

Treatment Pharmacokinetics Drugs Cell Biology 100

Agency IQ

OCTOBER 20, 2023

A study found that, of 23 FDA-approved biosimilar products, 21 had comparative efficacy established through one or more phase 3 clinical trials , which included “both an initial comparative efficacy period and additional follow-up, during which a subset of patients was switched between the biosimilar and reference products.”

Science 40

Science Biosimilars FDA Production 40

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products.

Regulations 59

Regulations Production FDA Approval Drugs 59

Drug Target Review

MARCH 20, 2025

.” In addition to AFib, Anthos Therapeutics is also investigating abelacimab’s potential in cancer-associated thrombosis, for which there are currently no FDA approved products. These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication.

Therapies 52

Therapies Trials Clinical Development FDA 52

The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Vaccine 40

Vaccine Production FDA Clinical Trials 40