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Find Clinical Drug Pipeline Developments & Deals by OPKO Healthcare
Entera Bio & Opko Health is developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
The agreement aims to advance a platform and specific candidates addressing a range of viral infectious diseases and will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology.
NGENLA (somatrogon-ghla), a once-weekly, HGH analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. it's expected to become available for U.S. prescribing in August 2023.
ModeX and Merck will jointly advance MDX-2201 to an IND application filing, after which Merck will be responsible for clinical and regulatory activities and product commercialization. MDX-2201 leverages ModeX’s innovative biologics platform to target multiple EBV proteins.
ModeX Therapeutics has developed highly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, simpler manufacturing and potentially better specificity and safety, providing significant differentiation from competing platforms.
The European Union marketing authorization of Ngenla (somatrogon) was supported by results from Phase 3 study which evaluated the safety and efficacy of once-weekly NGENLA compared to once-daily GENOTROPIN® (somatropin).
RAYALDEE extended-release capsules are indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency in pediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.
This approval is based on the results of a Phase 3 study conducted in Japanese subjects and a global clinical study, both of which were conducted in subjects with pediatric GHD, and compared the efficacy and safety of once-weekly NGENLA® with GENOTROPIN® (somatropin).
CHMP’s positive opinion of PF-06836922 (somatrogon) is based on the results from Phase 3, the study demonstrated that treatment improved the mean overall life interference total score after 12 weeks.