article thumbnail

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. The safety data currently available for the therapy is in line with over 3,500 Paxlovid-treated subjects across the EPIC clinical development programme.

HR 264
article thumbnail

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. billion to $1.28

HR 98
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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 of additional follow-up and 78.3% The results show a 25.1%

HR 52
article thumbnail

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; The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development. ESKD passed in0.9 of finerenone versus1.3 0.995; p = 0.046).

article thumbnail

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

The Pharma Data

We strongly believe in the results of the PROpel trial, which demonstrated the clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.” 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). 0.81; p<0.001). months and 16.6

HR 40
article thumbnail

New Data on Finerenone for the protection of patients with.

The Pharma Data

Finerenone significantly reduced the risk of the composite primary endpoint of time to first occurrence of CV death or non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization by 13% (relative risk reduction, HR 0.87 [95% CI: 0.76-0.98]; 1.09]) and heart failure hospitalization (HR 0.71 [95% CI: 0.56-0.90])

HR 52
article thumbnail

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

We strongly believe in the results of the PROpel trial, which demonstrated a clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.” In exploratory analyses of the BRCA m subgroup, patients in the LYNPARZA plus abi/pred arm had fewer rPFS (HR=0.23 [95% CI, 0.12-0.43])

HR 40