Pharmaceutical Industry Articles & Reports - Page 39

Explore biotech salary trends across global regions, updated with 2024-2025 data. Compares pay in top hubs like the US, Switzerland, and Asia-Pacific with cost-of-living analysis and funding recovery trends.

Learn the GAMP 5 software categories for computerized system validation. This guide explains each category with examples, risk levels, and how they align with the 2025 ISPE GAMP AI Guide and FDA CSA framework.

A comprehensive guide to lab equipment qualification (IQ/OQ/PQ). Learn the process, regulatory standards including FDA's finalized CSA guidance, and how AI-powered automation streamlines validation and compliance.

Learn about Japan's PMDA regulatory pathways for drug approval under the PMD Act, including 2025 amendments. Covers standard and expedited options like Sakigake, Orphan Drug, and Conditional Approval

An in-depth review of Certara's drug development software suite for MIDD, updated for 2026. Covers Phoenix WinNonlin, Phoenix Cloud, the Simcyp PBPK Simulator, Certara IQ AI-powered QSP platform, and ICH M15 adoption.

Learn about Patient-Reported Outcomes (PRO) systems in clinical trials. This guide covers ePRO data collection, PROMs, FDA PFDD guidelines, CONSORT 2025 updates, AI-driven ePRO platforms, and challenges

An in-depth study of pharmacy management systems updated for 2026. Explore key software features, compare top vendors (RedSail, Outcomes/TDS, Epic, Oracle Health), and learn about AI, DSCSA compliance, and market consolidation trends.

Updated 2026 guide to ICH M7 mutagenic impurity assessment software including Derek Nexus 6.5, Sarah Nexus 5.1, Leadscope 2025.0, OECD QSAR Toolbox 4.8, AmesNet deep learning, and nitrosamine regulatory developments.

Updated 2026 guide to AI-assisted surgery companies including Intuitive Surgical's da Vinci 5, Medtronic Hugo (FDA-cleared Dec 2025), CMR Versius Plus, Stryker Mako 4, and more. Market data, clinical outcomes, and regulatory trends.

A detailed analysis of the global pharmaceutical market, forecast to reach $1.6T by 2025. Explore key growth drivers, therapy areas, and industry challenges.

An in-depth guide to ICH Q10 Pharmaceutical Quality Systems (PQS), updated for 2026 with ICH Q9(R1), Q12-Q14 developments, FDA QMM program updates, and AI-driven quality management trends.

An in-depth analysis of the ICH E6(R3) Good Clinical Practice guidelines for 2025. Explore key changes in Quality by Design, data governance, and decentralized

Updated 2026 guide to synthetic data in pharmaceutical research. Covers acceptance criteria for fidelity, utility, and privacy, plus latest FDA/EMA AI guidance, EHDS, and diffusion model advances.

An overview of value-based contracting (VBC) in pharmaceuticals, where drug prices are tied to patient outcomes. Covers models, challenges, case studies, CMS CGT Access Model (2025), finalized VBP rule (2026), and IRA drug price negotiations.

An analysis of the 2025 surge in new drug manufacturing plants from Eli Lilly, AstraZeneca & more. Learn about the key drivers: supply chain & geopolitics.

A comprehensive guide to pharmaceutical licensing deals updated for 2026. Covers deal structures, co-development agreements, financial terms, milestone payments, royalty rates, and the record $250B+ licensing market with China-sourced innovation trends.

Learn best practices for writing an effective FDA 483 response. Updated with FY2024-2025 enforcement data and FDA's AI-driven inspection targeting. Covers CAPAs, timelines, and strategies to avoid Warning Letters.

Updated 2026 guide for IT on 21 CFR Part 11. Covers FDA CSA guidance, AI compliance, electronic records & signatures, system validation, audit trails & data integrity

A detailed profile of Cognition Therapeutics (CGTX) analyzing its pipeline, financials, and lead drug zervimesine (CT1812), a sigma-2 modulator for Alzheimer's and DLB, with 2025-2026 updates including Phase 3 plans, SHIMMER publication, and START trial enrollment.

Updated 2026 guide to HCP marketing in the pharmaceutical industry. Covers AI-driven personalization, omnichannel engagement, digital strategies, mobile-first content, and the latest FDA and IFPMA regulatory developments.

Explore Salesforce Health Cloud and Agentforce Life Sciences for biopharma. Updated for 2026 with Life Sciences Cloud GA, Agentforce AI, and new customer wins from Novartis and AstraZeneca.

Learn the key updates in ISPE GAMP 5 Second Edition. Updated for 2026 with FDA's finalized CSA guidance, ISPE GAMP AI Guide, and EU Annex 11/22 revisions

An in-depth analysis of Merck's GPTeal platform and expanding AI strategy. Covers the KERMT drug discovery model, Mayo Clinic partnership, CSR automation results, and enterprise-scale LLM deployment across pharma R&D.

An in-depth case study of AstraZeneca's ChatGPT and generative AI implementation, updated for 2026. Covers enterprise strategy, R&D use cases, self-healing supply chains, and agentic AI adoption.