Ferring`s Zomacton (Somatropin) Receives Suppl Approvals in the U.S
Eli Lilly`s Biologic Humatrope (somatropin) Receives Approval in the U.S.
Sandoz's Biologic Omnitrope (Somatropin) Receives Approval in the U.S.
COPENHAGEN, Denmark, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH) as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD). TransCon hGH is a prodrug of somatropin that provides sustained release of unmodified somatropin (hGH) at predictable therapeutic levels in the body.
COPENHAGEN, Denmark, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, today announced that it has filed a Clinical Trial Notification (CTN) with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to initiate the company’s phase 3 riGHt Trial of TransCon™ hGH (lonapegsomatropin), a long-acting prodrug of somatropin (hGH), for the treatment for pediatric growth hormone deficiency (GHD).
OPKO Health and Pfizer have reported positive results from the Phase III clinical trial of somatrogon compared to Genotropin (somatropin) in children suffering from growth hormone deficiency (GHD).
OPKO Health, a multinational biopharmaceutical and diagnostics company, and Pfizer announced that the global phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily Genotropin (somatropin) for injection, as measured by annual height velocity at 12 months.
The US Food and Drug Administration (FDA) on Tuesday released a preliminary list of the new drug applications (NDAs) that will be converted to biologics license applications (BLAs) on 23 March 2020.