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    [{"orgOrder":0,"company":"Centocor","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EC Approves PONVORYTM for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Centocor","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen\u2019s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Centocor","sponsor":"Legend Biotech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Seeks EU Approval for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (Cilta-Cel)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Centocor","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Receives Two Positive CHMP Opinions Recommending Expanded Use of DARZALEX SC Formulation for New Indications in Europe","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"}]

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              EC Approves PONVORYTM for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis

              Details:

              Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.

              Lead Product(s): Ponesimod

              Therapeutic Area: Immunology Product Name: Ponvory

              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 24, 2021

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              Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma

              Details:

              Study results show that responses were durable and deepened over time – 58 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better, and 40 percent achieved a complete response (CR) or better at the RP2D.

              Lead Product(s): Teclistamab

              Therapeutic Area: Oncology Product Name: JNJ-64007957

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 24, 2021

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              Janssen Receives Two Positive CHMP Opinions Recommending Expanded Use of DARZALEX SC Formulation for New Indications in Europe

              Details:

              The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of MM is supported by data from the Phase 3 APOLLO study conducted in collaboration with the European Myeloma Network.

              Lead Product(s): Daratumumab,Bortezomib,Cyclophosphamide

              Therapeutic Area: Genetic Disease Product Name: Darzalex

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 21, 2021

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              Janssen Seeks EU Approval for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (Cilta-Cel)

              Details:

              The application is supported by positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of Cilta-Cel.

              Lead Product(s): Ciltacabtagene Autoleucel

              Therapeutic Area: Oncology Product Name: Cilta-cel

              Highest Development Status: Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Legend Biotech

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 30, 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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