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    [{"orgOrder":0,"company":"Incannex Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Incannex Observes Substantial Reduction in AHI in Preliminary Results of Clinical Trial Assessing IHL-42x in Patients With OSA; Proceeds to Pivotal Studies","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II\/ Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Fortrea","sponsor":"Incannex Healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Incannex Engages Fortrea to Manage its FDA IND Opening Phase 2\/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase I"},{"orgOrder":0,"company":"Incannex Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Pre-IND Meeting with US FDA for IHL-42X for Obstructive Sleep Apnoea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase I"},{"orgOrder":0,"company":"Taro Pharmaceutical Industries","sponsor":"Sun Pharmaceutical Industries Limited","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Taro Announces Merger Agreement with Sun Pharma","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Incannex Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Incannex Announces Positive Results From Phase 2 Clinical Trial Investigating the Effect of IHL-42x for Treatment of Obstructive Sleep Apnoea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zydus Receives Final Approval from The USFDA for Acetazolamide Tablets USP, 125 mg and 250 mg","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"}]

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              Taro Pharmaceutical Industries

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              Taro Announces Merger Agreement with Sun Pharma

              Details:

              Through this merger, Sun Pharma will gain access to Taro's pipelines, enabling further commercialization in the market, including Diamox (acetazolamide), an carbonic anhydrase inhibitor used for treating edema due to congestive heart failure in patients.

              Lead Product(s): Acetazolamide

              Therapeutic Area: Cardiology/Vascular Diseases Product Name: Diamox

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Merger January 17, 2024

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              Fortrea

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              Incannex Engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea

              Details:

              Fortrea will manage Incannex's IND opening Phase 2/3 clinical trial investigating IHL-42X which is a synergistic composition of dronabinol, a synthetic form of Tetrahydrocannabinol, and acetazolamide, a carbonic anhydrase inhibitor, for treatment of obstructive sleep apnoea.

              Lead Product(s): Acetazolamide,Tetrahydrocannabinol

              Therapeutic Area: Sleep Product Name: IHL-42X

              Highest Development Status: Phase I Product Type: Small molecule

              Partner/Sponsor/Collaborator: Incannex Healthcare

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Partnership July 18, 2023

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              Zydus Lifesciences

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              Zydus Receives Final Approval from The USFDA for Acetazolamide Tablets USP, 125 mg and 250 mg

              Details:

              Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (eg, some types of glaucoma), in the treatment of certain convulsive disorders and in the promotion of diuresis in instances of abnormal fluid retention.

              Lead Product(s): Acetazolamide

              Therapeutic Area: Ophthalmology Product Name: Diamox-Generic

              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 April 06, 2023

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              Incannex Healthcare

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              Incannex Announces Positive Results From Phase 2 Clinical Trial Investigating the Effect of IHL-42x for Treatment of Obstructive Sleep Apnoea

              Details:

              All doses of IHL-42X (Dronabinol) reduced AHI in patients with sleep apnoea compared to baseline. This reduction was substantially greater than observed for placebo.

              Lead Product(s): Tetrahydrocannabinol,Acetazolamide

              Therapeutic Area: Sleep Product Name: IHL-42X

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 03, 2022

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              Incannex Healthcare

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              Positive Pre-IND Meeting with US FDA for IHL-42X for Obstructive Sleep Apnoea

              Details:

              IHL-42X (dronabinol) is a fixed-dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea (‘OSA’) in adults.

              Lead Product(s): Tetrahydrocannabinol,Acetazolamide

              Therapeutic Area: Sleep Product Name: IHL-42X

              Highest Development Status: Phase I Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 17, 2022

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              Incannex Healthcare

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              Incannex Observes Substantial Reduction in AHI in Preliminary Results of Clinical Trial Assessing IHL-42x in Patients With OSA; Proceeds to Pivotal Studies

              Details:

              20% of participants experienced a reduction in AHI of greater than 80% relative to baseline during at least one treatment period of one dose strength of IHL-42X and, average of low, mid, and high-dose IHL-42X reduced AHI in trial participants by 44.4%, compared to baseline.

              Lead Product(s): Tetrahydrocannabinol,Acetazolamide

              Therapeutic Area: Sleep Product Name: IHL-42X

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 10, 2022

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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