Ferring`s Zomacton (Somatropin) Receives Suppl Approvals in the U.S
Genexine’s once-weekly growth hormone has matched daily injections in a pivotal trial in China, teeing it and its partners I-Mab and Jumpcan up to file for approval next year and prepare to launch the medicine.
Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.
Sandoz's Biologic Omnitrope (Somatropin) Receives Approval in the U.S.
Pfizer’s bid to defend its growth hormone franchise against a new, more convenient competitor has hit a snag. The FDA has pushed back approval of Pfizer’s once-weekly prospect, giving rival Ascendis Pharma a longer window in which to convert physicians and patients from current daily options without competition.
Close to 3 years after Opko tried to defend itself as shares tumbled on the news that its long-acting growth hormone had failed to outperform a placebo, the Pfizer partner $PFE is back. And this time they’re pitching Phase III data that demonstrate their drug is non-inferior — or maybe a tad better — than their well-known but fading standard in the field.
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.
Ascendis aims to hit the Heights, while Lilly hopes for success with Olumiant in eczema, a new indication for the troubled Jak inhibitor.
Reaching what appears to be an end to its winding journey to market, the growth hormone drug Macrilen has just found a new home in the US and Canada.