Page 373 - தொழில் முனைவோர் மகேந்திரா நாத் பாண்டே News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Published: Mar 11, 2021 By Alex Keown Saniona, a rare disease-focused company based in Sweden, received feedback from the U.S. Food and Drug Administration (FDA) on a path forward for its hypothalamic obesity (HO) drug Tesomet. Based on guidance from the regulatory agency, Saniona is planning a Phase IIb study in this indication in the first half of this year. “There is currently no medicine approved for hypothalamic obesity, a rare disease secondary to hypothalamic injury, characterized by intractable weight gain and complicated by uncontrollable hunger,” Rudolf Baumgartner, Chief Medical Officer and Head of Clinical Development at Saniona said in a statement. “We are encouraged by this feedback from the FDA and look forward to continuing a constructive dialogue with them as we prepare to initiate our Phase IIb clinical trial with Tesomet.”

United kingdomUnited statesNordrhein westfalenSouth koreaRudolf baumgartnerOrionis biosciencesEli lillyDepartment of pureContract developmentUniversity of strathclydeManufacturing organizationAvacta groupIsrael biologic design ltdExelixis incMainstay medical holdingsTherapeutics limited