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In the News: October Regulatory and Development Updates

Camargo

Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc.

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Drug discovery quarterly review: Second quarter 2023  

Drug Discovery World

Excluding Covid-19 medicines, total revenue increased 16% and product sales increased 15%. For Sanofi, second quarter 2023 sales growth of 3.3% AstraZeneca saw total revenue reach $22,295m, up 4% despite a decline of $2,181m from Covid-19 medicines. at CER and business EPS growth of 8.1% Specialty care grew 11.8% Vaccines were up 9.1%

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Drug discovery hotspots: Focus on Qatar

Drug Discovery World

Indeed, QCRI is currently working with other organisations in Qatar including Qatar Biobank, to further research and develop data sets that contain whole genome sequences. “Current work at QCRI focuses on developing polygenic risk scores for complex diseases and traits using local Qatari data.

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IN FOCUS: Solvias

Pharmaceutical Technology

In regards to the latter, notable examples include the acquisition of Cergentis, a genomics-focused biotechnology company based in the Netherlands. The deal allows the company to provide proprietary technology and knowledge steeped in fast-evolving genomic techniques that support effective decision-making and R&D program design.

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Life sciences must become cloud-first to seize the science of tomorrow

pharmaphorum

One estimate [1] suggests that by 2025 more than 60 million patients will have their genome sequenced. Additionally, in a risk averse industry, driven by understandable concerns with regards to data security and regulation, many life sciences businesses have been reluctant to make more aggressive moves to cloud. Data governance.

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COVID-19: We don’t need another hero

pharmaphorum

There’s an opportunity to move forward with real-time, informative systems designed to guide and support staff and provide the automated audit trail for compliance and regulators, so that quality is embedded as a routine. Any modern business will recognise today that staff are the greatest asset.

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Hepion Pharmaceuticals Completes 75 mg CRV431 Dosing, Initiates 225 mg Dosing in Phase 2a ‘AMBITION’ Clinical Trial for NASH

The Pharma Data

Hepion will also conduct Fibroscans and examine a multitude of candidate biomarkers of NASH resolution and CRV431 efficacy including Pro-C3, Enhanced Liver Fibrosis (ELF) markers, collagens, matrix metalloproteinases, transcriptomics, liver transaminases, and full-scale lipidomic and genomic signatures.