Turning Point

PharmaShots Weekly Snapshots (October 11 – 15, 2021)

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & …

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Turning Point and EQRx Collaborate to Evaluate Elzovantinib + Aumolertinib in Patients with EGFR Mutant Met-Amplified Advanced NSCLC

Shots: The companies collaborated to assess Turning Point’s elzovantinib (TPX-0022) in combination with EQRx’s aumolertinib in patients with EGFR mutant MET-amplified advanced NSCLC Turning Point will sponsor and conduct a P-Ib/II clinical trial to evaluate the safety, tolerability and preliminary efficacy of the combination regimen and will assume all costs associated with the trial whereas …

Turning Point and EQRx Collaborate to Evaluate Elzovantinib + Aumolertinib in Patients with EGFR Mutant Met-Amplified Advanced NSCLC Read More »

Turning Point Presents Results of Repotrectinib in P-I/II TRIDENT-1 Study for the Treatment of Solid Tumors at AACR-NCI-EORTC 2021

Shots: The P-I/II TRIDENT-1 study evaluates repotrectinib in NTRK-positive TKI-naïve & pretreated advanced solid tumors. The early P-II data use an Aug 26, 2021 cutoff data The preliminary efficacy analysis in both population showed cORR (41% & 48%); 3 patients achieved SD with tumor regression of -21%, -23% & -27% in TKI-naïve; DoR (1.9+ to …

Turning Point Presents Results of Repotrectinib in P-I/II TRIDENT-1 Study for the Treatment of Solid Tumors at AACR-NCI-EORTC 2021 Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

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