CSBio CSBio

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[{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Expands Ready-to-Administer Portfolio with Diazepam Injection, USP in Simplist\u00ae Prefilled Syringe","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Fresenius Kabi AB Brunna"},{"orgOrder":0,"company":"Camurus","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Camurus Announces Submission of Request for Final Approval of Brixadi\u2122 for the Treatment of Opioid Use Disorder in the US","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Camurus"},{"orgOrder":0,"company":"Camurus","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The Australian TGA Approves Key Label Updates to Buvidal\u00ae for Treatment of Opioid Dependence","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Camurus"},{"orgOrder":0,"company":"Camurus","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Camurus Announces FDA Approval of Brixadi\u2122 for the Treatment of Moderate to Severe Opioid Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Camurus"},{"orgOrder":0,"company":"Orexo","sponsor":"Accord healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Orexo Enters Exclusive License and Supply Agreement with Accord Healthcare for ZUBSOLV\u00ae in Europe","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orexo"},{"orgOrder":0,"company":"Orexo","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orexo Announces New Us Patent for Zubsolv\u00ae","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orexo"}]

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            Diazepam Injection is a ready-to-administer prefilled syringes which is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.

            Lead Product(s): Diazepam

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            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 May 31, 2023

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            Brixadi™ (buprenorphine) injection for SC, will be indicated for the treatment of severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

            Lead Product(s): Buprenorphine

            Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi

            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 May 23, 2023

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            The approval includes new higher Buvidal monthly 160 mg dose direct initiation onto Buvidal weekly, changing the contraindications in pregnancy and lactation to precautions.

            Lead Product(s): Buprenorphine

            Therapeutic Area: Psychiatry/Psychology Product Name: Buvidal

            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 May 03, 2021

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            The new patent, US Patent further strengthens the company's intellectual property for ZUBSOLV® in the US. Orexo will now have six patents listed in the Orange Book for ZUBSOLV®.

            Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv

            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 30, 2020

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            Under the terms of the agreement, Orexo will be responsible for product supply and Accord will take responsibility for the commercialisation of ZUBSOLV®. Orexo will receive double-digit royalties on future net sales.

            Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Accord healthcare

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement December 07, 2020

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            Details:

            The pivotal Phase 3 efficacy and safety trial demonstrated that Brixadi met the primary endpoint of non-inferiority for responder rate vs current standard of care and superiority for the secondary endpoint for the percentage of negative opioid assessments.

            Lead Product(s): Buprenorphine

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            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 June 01, 2020

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