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    [{"orgOrder":0,"company":"Innocoll Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innocoll Holdings Limited Resubmits New Drug Application to FDA for XARACOLL","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Innocoll Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innocoll Holdings Limited Announces FDA Acceptance of New Drug Application for XARACOLL","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Innocoll Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves XARACOLL\u00ae (bupivacaine HCl) Implant","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Innocoll Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innocoll Announces Commercial Launch of XARACOLL\u00ae (bupivacaine HCI) Implant","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Innocoll Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innocoll Announces Positive Topline Results For XARACOLL\u00ae (bupivacaine hydrochloride) Implant in a Phase 3 Study to Support Expanded Use","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Acasti Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acasti Pharma Announces Initiation of Pharmacokinetic Study for GTX-101, the Company\u2019s Drug Candidate for the Treatment of Postherpetic Neuralgia","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Acasti Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acasti Pharma Announces Preliminary Topline Results Met All Primary Outcome Measures in the Single Dose Pharmacokinetic Study for GTX-101, the Company\u2019s Drug Candidate for the Treatment of Postherpetic Neuralgia (PHN)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"MedinCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MedinCell Announces Successful Completion of Patient Enrollment in the Phase 3 Study of F14 (mdc-CWM), a First-in-Class Therapy for Localized Pain Relief After Total Knee Replacement","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

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              MedinCell

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              MedinCell Announces Successful Completion of Patient Enrollment in the Phase 3 Study of F14 (mdc-CWM), a First-in-Class Therapy for Localized Pain Relief After Total Knee R...

              Details:

              F14 (celecoxib) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.

              Lead Product(s): Celecoxib,Bupivacaine Hydrochloride,Paracetamol

              Therapeutic Area: Neurology Product Name: F14 (mdc-CWM)

              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 August 30, 2023

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              Acasti Pharma

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              Acasti Pharma Announces Preliminary Topline Results Met All Primary Outcome Measures in the Single Dose Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate fo...

              Details:

              GTX-101 is a novel formulation of bupivacaine hydrochloride for topical administration via a bio-adhesive, film-forming polymer, for relief of pain associated with Postherpetic Neuralgia, a neuropathic pain caused by nerve damage from the varicella zoster virus (shingles).

              Lead Product(s): Bupivacaine Hydrochloride

              Therapeutic Area: Neurology Product Name: GTX-101

              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 December 22, 2022

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              Acasti Pharma

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              Acasti Pharma Announces Initiation of Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic Neuralgia

              Details:

              GTX-101 (bupivacaine hydrochloride) topical administration via bio-adhesive, film-forming polymer, for relief of pain associated with PHN, a persistent and often debilitating neuropathic pain caused by nerve damage from shingles, which may persist for months and even years.

              Lead Product(s): Bupivacaine Hydrochloride

              Therapeutic Area: Neurology Product Name: GTX-101

              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 July 27, 2022

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              Innocoll Pharmaceuticals Limited

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              Innocoll Announces Positive Topline Results For XARACOLL® (bupivacaine hydrochloride) Implant in a Phase 3 Study to Support Expanded Use

              Details:

              XARACOLL (Bupivacaine HCl), an innovative collagen drug-device implant, 300mg dose cohort experienced less pain and, was generally well tolerated with an adverse event profile comparable to the current prescribing information.

              Lead Product(s): Bupivacaine Hydrochloride

              Therapeutic Area: Neurology Product Name: Xaracoll

              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 March 02, 2022

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              Innocoll Pharmaceuticals Limited

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              Innocoll Announces Commercial Launch of XARACOLL® (bupivacaine HCI) Implant

              Details:

              Approved by the US Food and Drug Administration (FDA) in August 2020, XARACOLL is a unique, non-injectable, drug-device combination in the form of a fully bioresorbable collagen implant containing bupivacaine hydrochloride.

              Lead Product(s): Bupivacaine Hydrochloride

              Therapeutic Area: Neurology Product Name: Xaracoll

              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 October 29, 2020

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              Innocoll Pharmaceuticals Limited

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              FDA Approves XARACOLL® (bupivacaine HCl) Implant

              Details:

              US Food and Drug Administration (FDA) has approved Xaracoll® for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair, a painful and commonly-performed surgery.

              Lead Product(s): Bupivacaine Hydrochloride

              Therapeutic Area: Neurology Product Name: Xaracoll

              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 August 31, 2020

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              Innocoll Pharmaceuticals Limited

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              Innocoll Holdings Limited Announces FDA Acceptance of New Drug Application for XARACOLL

              Details:

              If approved, XARACOLL will be Innocoll's first commercially available product in the US.

              Lead Product(s): Bupivacaine Hydrochloride

              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 March 26, 2020

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              Innocoll Pharmaceuticals Limited

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              Innocoll Holdings Limited Resubmits New Drug Application to FDA for XARACOLL

              Details:

              Innocoll anticipates a 6-month review by the FDA.

              Lead Product(s): Bupivacaine Hydrochloride

              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 February 27, 2020

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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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