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Industry Trade Show
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16-18 July, 2025
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29 June-01 July, 2025
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01-02 July, 2025
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18 Apr 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125289
01 Apr 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125261
18 Mar 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125261
16 Nov 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125289
30 Mar 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125289
07 Oct 2021
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103772
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18593
Submission : 1987-09-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18594
Submission : 1985-03-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18586
Submission : 1991-05-24
Status : Inactive
Type : II
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 Brand Name: JNJ-64007957
Study Phase: Phase IIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 24, 2021
Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients wi...
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.
Product Name : JNJ-64007957
Product Type : Antibody
Upfront Cash : Inapplicable
May 24, 2021
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: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 24, 2021
Lead Product(s) : Ponesimod
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 24, 2021
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 Brand Name: Darzalex
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 21, 2021
Lead Product(s) : Daratumumab,Bortezomib,Cyclophosphamide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Darzalex
Product Type : Antibody
Upfront Cash : Inapplicable
May 21, 2021
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 Brand Name: Cilta-cel
Study Phase: Phase IIIProduct Type: Cell and Gene therapy
Sponsor: Legend Biotech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 30, 2021
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.
Product Name : Cilta-cel
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
April 30, 2021
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