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Lead Product(s): Atezolizumab,Cabozantinib
Therapeutic Area: Oncology Product Name: Tecentriq
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Takeda Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 10, 2020
Details:
Subsequent to a joint clinical research agreement between Roche and Exelixis, Chugai and Takeda have decided to study Tecentriq® (atezolizumab) and CABOMETYX® (cabozantinib) combination therapy in Japan.
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Lead Product(s): Nivolumab,Bevacizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: Opdivo
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
This study is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study evaluating Opdivo in combination treatment with bevacizumab and chemotherapy versus placebo in combination with bevacizumab and chemotherapy.
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Lead Product(s): Pevonedistat,Azacitidine
Therapeutic Area: Oncology Product Name: MLN4924
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 July 30, 2020
Details:
The Breakthrough Therapy Designation is based on the final analysis of the Pevonedistat-2001 Phase 2 study, which evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including HR-MDS.
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Lead Product(s): Polatuzumab Vedotin,Rituximab,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Polivy
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
This application is based on the results from a multicenter, single-arm Japanese phase II study that evaluated the efficacy and safety of the combination therapy of polatuzumab vedotin with bendamustine and rituximabin relapsed or refractory DLBCL.
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Lead Product(s): Pexidartinib
Therapeutic Area: Oncology 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 June 26, 2020
Details:
CHMP of the European Medicines Agency has adopted a negative opinion on the Marketing Authorization Application For pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumor (TGCT).
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Lead Product(s): Pevonedistat,Azacitidine
Therapeutic Area: Oncology 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 May 14, 2020
Details:
Takeda will present data from its expanding oncology pipeline and established product portfolio at two upcoming scientific congresses: ASCO and EHA, that includes clinical data on Pevonedistat, ICLUSIG, NINLARO and among others.
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Lead Product(s): Nivolumab,Cabozantinib,Ipilimumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2020
Details:
Opdivo and cabozantinib combination treatment demonstrated a significant benefit in its primary endpoint of progression-free survival (PFS) at final analysis, compared to sunitinib alone.
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Lead Product(s): Bendamustine
Therapeutic Area: Oncology 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 30, 2020
Details:
SymBio Pharmaceuticals Limited has completed patient enrollment in a clinical trial for TREAKISYM rapid infusion in Japan. Company plans to submit a New Drug Application for the product.
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Lead Product(s): Ixazomib,Lenalidomide,Dexamethasone
Therapeutic Area: Oncology 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 10, 2020
Details:
The addition of ixazomib to lenalidomide and dexamethasone resulted in an improvement in median progression-free survival of 13.5 months; however, it did not meet the statistical significance.
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Lead Product(s): Brigatinib
Therapeutic Area: Oncology 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 24, 2020
Details:
The sNDA is based on results from the Phase 3 ALTA-1L trial, which is evaluating the safety and efficacy of ALUNBRIG in patients with ALK+ locally advanced or metastatic NSCLC.
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