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    [{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Provides Business Update Related to COVID-19 Pandemic","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Provides Update on Clinical Trials and Development Programs","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Otonomy","sponsor":"ALK","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ALK Enters into Co-Promotion Agreement with Otonomy for OTIPRIO\u00ae, the First and Only Single-Dose Treatment for Acute Otitis Externa","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Positive Top-Line Results from Phase 1\/2 Clinical Trial of OTO-313 in Patients with Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Provides Update on OTIVIDEX\u00ae Program","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Otonomy","sponsor":"KYORIN PHARMACEUTICAL CO LTD","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Otonomy Announces Exclusive License Agreement with Kyorin for Novel Compound in OTO-6XX Hearing Loss Program","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Provides Update on OTIVIDEX\u00ae and OTO-313 Programs","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Positive Top-Line Results from Phase 1\/2 Clinical Trial of OTO-413 in Patients with Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Announces Top-Line Results for the Phase 3 Clinical Trial of OTIVIDEX\u00ae in Patients with M\u00e9ni\u00e8re's Disease","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase II"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Eyes Clinical Trial of Hearing Loss Gene Therapy","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Otonomy","sponsor":"ALK","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ALK Acquires OTIPRIO\u00ae (Ciprofloxacin Otic Suspension), Broadening Treatment Solutions for Healthcare Providers and Patients","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Initiates Expansion of Phase 1\/2 Clinical Trial for OTO-413 in Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Completes Enrollment in Phase 2 Clinical Trial of OTO-313 in Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase II"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Announces OTO-825 Presentation at the American Society of Gene & Cell Therapy Annual Meeting","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Results from Phase 2 Clinical Trial of OTO-313 in Patients with Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase II"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II"}]

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              Otonomy

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              Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss

              Details:

              OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair.

              Lead Product(s): OTO-413

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

              Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 13, 2022

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              Otonomy Reports Results from Phase 2 Clinical Trial of OTO-313 in Patients with Tinnitus

              Details:

              OTO-313 did show a higher response rate than placebo in a prospectively defined patient subgroup with tinnitus duration of less than 6 months (population studied in Phase 1/2 trial), the overall results do not support further development of OTO-313.

              Lead Product(s): Gacyclidine

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313

              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 August 01, 2022

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              Otonomy Announces OTO-825 Presentation at the American Society of Gene & Cell Therapy Annual Meeting

              Details:

              OTO-825, is an AAV-mediated gene therapy targeting the gap junction beta-2 (GJB2) administration rescues hearing and cochlear damage in two preclinical models of congenital hearing loss caused by GJB2 deficiency.

              Lead Product(s): OTO-825

              Therapeutic Area: Genetic Disease Product Name: OTO-825

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 12, 2022

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              Otonomy

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              Otonomy Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing Loss

              Details:

              40% (8 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 20% (2 out of 10) for placebo.

              Lead Product(s): Brain-Derived Neurotrophic Factor

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

              Highest Development Status: Phase I/ Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 20, 2022

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              Otonomy Completes Enrollment in Phase 2 Clinical Trial of OTO-313 in Tinnitus

              Details:

              Patients were randomized 1:1 to a single intratympanic injection of OTO-313 or placebo and are being followed for 4 months in Phase 2 trial. OTO-313, a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine for treatment of tinnitus.

              Lead Product(s): Gacyclidine

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313

              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 February 22, 2022

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              Otonomy

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              Otonomy Initiates Expansion of Phase 1/2 Clinical Trial for OTO-413 in Hearing Loss

              Details:

              OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests in dose escalation efficacy cohort.

              Lead Product(s): Brain-Derived Neurotrophic Factor

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

              Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 15, 2021

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              ALK Acquires OTIPRIO® (Ciprofloxacin Otic Suspension), Broadening Treatment Solutions for Healthcare Providers and Patients

              Details:

              OTIPRIO is a sterile, preservative-free, otic suspension of 6 percent ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.

              Lead Product(s): Ciprofloxacin

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otiprio

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: ALK

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Acquisition June 03, 2021

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              Otonomy Eyes Clinical Trial of Hearing Loss Gene Therapy

              Details:

              Results demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two preclinical models that represent a range of hearing loss severity caused by GJB2 deficiency.

              Lead Product(s): Dexamethasone

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex

              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 May 14, 2021

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              Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus

              Details:

              OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate receptor antagonist gacyclidine. Phase 2 study design based on successful Phase 1/2 trial including use of Tinnitus Functional Index responder analysis for primary efficacy endpoint.

              Lead Product(s): Gacyclidine

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313

              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 March 25, 2021

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              Otonomy

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              Otonomy Announces Top-Line Results for the Phase 3 Clinical Trial of OTIVIDEX® in Patients with Ménière's Disease

              Details:

              The Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat population using the Negative Binomial Model.

              Lead Product(s): Dexamethasone

              Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex

              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 February 22, 2021

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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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