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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

Weekly Digest 7

Regulatory  ·  Weekly Digest 7
Inovio to receive Orphan designation in EU for HPV-related diseases 

Weekly Digest – 22-28 Apr 2023 Weekly Digest – 22-28 Apr 2023 April 26, 2023: INO-3107 / HPV-related diseases / Inovio Pharmaceuticals: Positive COMP opinion for Orphan Drug Designation in EU INOVIO announced that the European Committee for Orphan Medicinal […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 7
CHMP recommended EU approval of Roche’s Columvi in DLBCL

Weekly Digest – 22-28 Apr 2023 Weekly Digest – 22-28 Apr 2023 April 26, 2023: Glofitamab (IV) / DLBCL / Roche: Received positive CHMP recommendation for EU approval  CHMP has recommended the approval of Columvi for DLBCL after two or […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 7
FDA raised question on efficacy of Merck/AZ’s Lynparza for prostate cancer

Weekly Digest – 22-28 Apr 2023 Weekly Digest – 22-28 Apr 2023 April 26, 2023: Olaparib (IV) / mCRPC/ Merck/ AstraZeneca: FDA questioned on efficacy data from PROpel study FDA debated on briefing documents released ahead of an advisory committee […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest 7
FDA granted Fast Track Designation for 177Lu-PNT2002 for the treatment of mCRPC

Weekly Digest – 22-28 Apr 2023 Weekly Digest – 22-28 Apr 2023 April 24, 2023: 177Lu-PNT2002 (IV) / Prostate Cancer / Lantheus and POINT Biopharma: Granted fast track designation by US FDA US FDA has granted fast track designation for […]

by Sandhya Ramalingam

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Clinical  ·  Weekly Digest 7
Ideaya’s Darovasertib + Crizotinib showed encouraging results in metastatic Uveal Melanoma

Weekly Digest – 22-28 Apr 2023 Weekly Digest – 22-28 Apr 2023 April 23, 2023: Darovasertib (oral) and Crizotinib (oral) / Uveal Melanoma / Ideaya: Positive Phase 2 data and successful FDA Type C meeting on registrational trial design Ideaya […]

by Sandhya Ramalingam

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