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Medtronic Reflux Device Linked to 184 Serious Injuries, FDA Warns

(MedPage Today) -- The FDA on Thursday warned of 184 serious injuries linked to recalled Bravo calibration-free (CF) acid-monitoring capsule delivery devices, which are used to help diagnose gastroesophageal reflux. "Medtronic stated that the...

Medtronic Reflux Device Linked to 184 Serious Injuries, FDA Warns

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Samsung Bioepis Initiates Phase 1 Clinical Trial for SB35, A Biosimilar Candidate Referencing Taltz (Ixekizumab)

Samsung Bioepis Co., Ltd. announced on Aug. 28 the initiation of Phase 1 clinical trial for SB35, a biosimilar candidate referencing Taltz (ixekizumab).The Phase 1 clinical trial for SB35 is a…

  • Samsung Bioepis begins Phase 1 trial for SB35 biosimilar on August 28
  • Study compares pharmacokinetics, safety, tolerability, immunogenicity of SB35 vs Taltz
  • Primary outcomes measured: AUCinf, Cmax, AUClast from Day 1 to Day 85

More from Friday 28 August →