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Pfizer seeks approval from US FDA for Covid-19 treatment

Pharmaceutical Technology

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. Furthermore, findings from the final trial report showed a relative risk decline of 86%.

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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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Phase II/III trial to assess LAG-3 immunotherapy in breast cancer 

Drug Discovery World

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

The Pharma Data

placebo donors (HR = 0.64; 95 CI0.41-0.995; Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “ ESKD passed in0.9 of finerenone versus1.3 0.995; p = 0.046).

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The latest advances in breast cancer therapy

Drug Discovery World

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months in heavily pre-treated patients. “We

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Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer

The Pharma Data

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. maturity, HR of 0.81, 95% CI 0.67-1.00; 0.43) and OS (HR of 0.29, 95% CI, 0.14-0.56). 0.94), and a modest trend for OS (HR of 0.91, 95% CI, 0.73-1.13).

HR 40
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Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

The Pharma Data

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. 0.43]) and OS (HR=0.29 [95% CI, 0.14-0.56]) 1.00]; p=0.0544). While the observed 7.4-month

HR 40