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FDA Approves

The Pharma Data

This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59])

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Three trends in the antibody-drug conjugate (ADC) market 

Drug Discovery World

The platform technology of Synaffix is capable of consistently converting any antibody into a best-in-class ADC (in terms of efficacy and safety profile) without any engineering of the genetic sequence of the antibody.” 2.

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Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

XTalks

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.

HR 98
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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). Senior Vice President and Head of Global Clinical Development at Regeneron. The results passed the futility analysis (p<0.3 log 10 copies/mL for combined doses).

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Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

The Pharma Data

In the overall study population, Libtayo significantly reduced the risk of death by 32% and extended median overall survival (OS) by 8 months compared to chemotherapy, even with 74% of patients crossing over to Libtayo following disease progression on chemotherapy (hazard ratio HR: 0.68; 95% confidence interval CI: 0.53-0.87; 0.87; p=0.0022).

Trials 52
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FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

The Pharma Data

PH1 is an ultra-rare genetic disease characterized by oxalate overproduction. Together, the ILLUMINATE studies comprise a comprehensive clinical development program intended to demonstrate the safety and efficacy of Oxlumo across the full spectrum of patients diagnosed with PH1. 0.514 mmol/24 hr/1.73