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BARCELONA, Spain, Jan. 18, 2021 /PRNewswire/ Grifols (MCE: GRF, MCE: GRF.P,NASDAQ: GRFS), a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people s health and well-being, today announced it will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug based on the Grifols immunoglobulin Gamunex®-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.
The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. In addition, it could protect the elderly and healthcare workers as well as immunocompromised patients for whom vaccination isn t recommended. It could also help contain outbreaks in places where the vaccination hasn t begun or is still
is the first FDA approved proprietary product for Athenex
First-in-class microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) on the face or scalp with a 5-day application course
Klisyri will be manufactured by Athenex
Almirall will launch Klisyri in the U.S. in first quarter 2021
BUFFALO, N.Y., Dec. 15, 2020 (GLOBE NEWSWIRE) Athenex, Inc., (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) 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. during the first quarter of 2021. Klisyri will be manufactured by Athenex, highlighting the vertically integrated cap
Almirall announces FDA approval of Klisyri® (tirbanibulin), a new innovative topical treatment for actinic keratosis Klisyri® (tirbanibulin) is a novel microtubule inhibitor, indicated for the topical treatment of actinic keratosis (AK) on the face or scalp Actinic keratosis is the second most common diagnosis made by dermatologists in the United States1 In one of the largest Phase III clinical study programs2 ever conducted for a topical AK treatment, tirbanibulin demonstrated complete clearance of actinic keratosis lesions at day 57 in treated face or scalp areas in a significantly higher number of patients than with vehicle Klisyri has a demonstrated safety profile with no patient withdrawals due to adverse events, and a convenient 5-day application period which is the shortest of any topical treatment for AK