Pharmaceutical Industry Articles & Reports - Page 2

Analyze the FDA's three-month PDUFA delay for subcutaneous Sarclisa. Examine its on-body injector technology, clinical data, and anti-CD38 competitors.

Examine the $10.5B Pfizer-Innovent collaboration. This analysis covers their 12-drug ADC oncology portfolio and the China cross-border licensing playbook.

Analyze the May 2026 FDA approval of Afrezza inhaled insulin for pediatric diabetes. Review INHALE-1 clinical trial data, T1D/T2D options, and market impacts.

Review the May 2026 FDA approval of Decnupaz (pivekimab sunirine), the first CD123-targeted ADC for BPDCN. Explores clinical efficacy and launch strategies.

Analyze the role of Perceptic's AI operating system in pharmaceutical R&D. Learn how unifying end-to-end data pipelines impacts drug discovery processes.

Examine the FDA's August 2026 PDUFA extension for Leqembi IQLIK. Understand the subcutaneous lecanemab clinical data, treatment costs, and infusion capacity.

Examine Eli Lilly's $3.8B acquisition of three biotechs to build an infectious disease vaccine pipeline targeting shingles, EBV, and resistant bacteria.

Learn how AI pathology and deep-learning TME quantification link to postoperative ctDNA status and clinical outcomes in stage III colon cancer patients.

Analyze Google Science Skills and Gemini for Science. Understand how AlphaFold and AlphaGenome integrations impact pharma informatics and vendor evaluation.

A comprehensive guide to the ICH Q14 analytical procedure development guideline. Review the enhanced QbD approach, lifecycle management, and ATP integration.

A comprehensive guide to ICH Q3D elemental impurities in pharmaceuticals, detailing risk assessment methodologies, permitted daily exposures, and software.

Examine extractables and leachables (E&L) testing in pharmaceuticals. This guide reviews analytical methodologies, risk assessment, and ICH Q3E guidelines.

An in-depth review of pharma supplier qualification and vendor audit programs. Examines GMP regulations, risk tiering, and quality management software tools.

Explore pharmaceutical cold chain management, global GDP compliance standards, and temperature-controlled distribution software systems in this 2026 guide.

Learn about nitrosamine impurities in pharma, including 2026 FDA guidance, formation mechanisms, acceptable intake limits, and AI risk assessment tools.

A review of the ICH Q13 continuous manufacturing guideline for pharmaceuticals, covering regulatory frameworks, control strategies, and industry implementation.

Review the FDA accelerated approval of Hepcludex (bulevirtide) for chronic hepatitis delta virus (HDV), including clinical trial data and public health impact.

Review the 2026 landscape of PBPK modeling and MIDD. This educational report analyzes Simcyp vs GastroPlus, FDA regulatory acceptance, and animal-free NAMs.

Compare leading in silico ADMET prediction software for drug discovery. Analyze feature matrices, predictive accuracy, and FDA NAM compliance across tools.

Explore the OMOP Common Data Model (CDM) and OHDSI. This guide explains how standardizing real-world data enables global federated network studies in pharma.

Analyze 2026 pharma KPI benchmarks. Learn industry median targets for manufacturing OEE, batch release cycle times, deviation rates, and R&D productivity.

Analyze the FDA real-time AI clinical trial pilot with AstraZeneca and Amgen. Learn how cloud-based continuous monitoring impacts trial duration and workflows.

Review Teva's $700M acquisition of Emalex Biosciences. Explore how ecopipam, a dopamine D1 antagonist, advances pediatric Tourette syndrome and CNS therapies.

Review how Microsoft Teams, SharePoint, Box, Egnyte, Slack, and Veeva Vault handle FDA 21 CFR Part 11 compliance and GxP document control in life sciences.