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    [{"orgOrder":0,"company":"Sedana Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sedana Medical Announces Positive Top Line Result in Pivotal IsoConDa Study","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sedana Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sedana Medical Receives Approval for European Dossier","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sedana Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sedana Medical Submits IND for US Clinical Trials","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sedana Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sedana Medical receives IND approval for US trials","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Sedana Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sedana Medical Receives FDA Fast Track Designation in The United States","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

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              Sedana Medical

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              Sedana Medical Receives FDA Fast Track Designation in The United States

              Details:

              Sedaconda (isoflurane), a general inhalation anesthetic, acts as a positive allosteric GABAA receptor modulator. It enhances glycine receptor activity, which decreases motor function and inhibits NMDA glutamate receptor, which mediates excitatory neurotransmission activity.

              Lead Product(s): Isoflurane

              Therapeutic Area: Neurology Product Name: Undisclosed

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 04, 2023

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              Sedana Medical

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              Sedana Medical receives IND approval for US trials

              Details:

              Company received IND clearance from the USFDA to initiate phase III pivotal clinical trials with its combination registration of medical device Sedaconda ACD and pharmaceutical Sedaconda (isoflurane) for sedation of mechanically ventilated intensive care patients.

              Lead Product(s): Isoflurane

              Therapeutic Area: Neurology Product Name: Sedaconda

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 23, 2021

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              Sedana Medical Submits IND for US Clinical Trials

              Details:

              Sedaconda (isoflurane) for inhaled sedation used in combination with medical device Sedaconda ACD, it's primary endpoint in each study will is effective and non-inferior to propofol for sedation of mechanically ventilated patients in the intensive care unit.

              Lead Product(s): Isoflurane

              Therapeutic Area: Neurology Product Name: Sedaconda

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 24, 2021

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              Sedana Medical Receives Approval for European Dossier

              Details:

              The topline results, announced in July 2020, showed that the study reached its primary goal; to show that Sedaconda administered via AnaConDa is an effective sedation method for ventilated ICU patients, comparable to propofol.

              Lead Product(s): Isoflurane

              Therapeutic Area: Neurology Product Name: Sedaconda

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 20, 2021

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              Sedana Medical Announces Positive Top Line Result in Pivotal IsoConDa Study

              Details:

              The results indicate that IsoConDa is an effective and safe sedation method and will form the basis for the company's application for European market approval later this autumn.

              Lead Product(s): Isoflurane

              Therapeutic Area: Neurology Product Name: IsoConDa

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 10, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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