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BioSpace Global Roundup, March 11

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.” ....

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Saniona AB: Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity

Saniona AB: Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity
March 8, 2021
Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced it received feedback from the U.S. Food and Drug Administration (FDA) providing further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO). Based on this feedback, Saniona is proceeding with plans to initiate a Phase 2b study in HO 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, said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. We are encouraged by this feedback from the FDA and look forward to continuing a constructive dialogue with them as we prepare to initiat ....

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Saniona AB: Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome

PRESS RELEASE March 3, 2021 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted ....

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Investegate |Saniona AB Announcements | Saniona AB: Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome

Investegate |Saniona AB Announcements | Saniona AB: Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome
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Camerata Basilea: Junges Streichorchester zeichnet Konzertprogramm auf: «Hauptsache, wir können spielen!»

Camerata Basilea: Junges Streichorchester zeichnet Konzertprogramm auf: «Hauptsache, wir können spielen!»
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