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PwC Sees $110B Women’s Oncology Market, but Early Detection Still Lags

The global market for women-specific cancers could reach $100 billion to $110 billion by 2030, according to a new PwC report. However, achieving that growth will require more than new investment. Pharmaceutical developers, diagnostic manufacturers and regulators must also close
  • News
PwC Sees $110B Women’s Oncology Market, but Early Detection Still Lags

Pharma Quality Systems in 2026: ICH Q10, GMP Compliance, and PQS Guide

Discover how pharma quality systems based on ICH Q10 strengthen GMP compliance through CAPA, change management, quality risk management, and management review. Learn how an effective pharmaceutical quality system improves inspection readiness, prevents recurring failures, and supports continual improvement.
  • Blog, Quality Management System
Pharmaceutical quality management system infographic showing ICH Q10 elements, CAPA system, quality risk management, and GMP quality controls in pharma manufacturing.

Lilly’s $3.8B Psychedelic Bet, FDA Guidance Shifts Focus to Phase III Risks

Eli Lilly has agreed to acquire AtaiBeckley for up to $3.8 billion as the FDA introduces a clearer regulatory framework for psychedelic drug development. The deal adds the Phase III depression candidate BPL-003 to Lilly’s neuroscience pipeline. More importantly, the
  • News
Lilly’s $3.8B Psychedelic Bet, FDA Guidance Shifts Focus to Phase III Risks

One Phase 3 Win Wasn’t Enough: GSK’s Camlipixant Blockbuster Hope Collapses

GSK has stopped developing camlipixant for refractory chronic cough after mixed results from two Phase 3 trials. Although the drug met one primary endpoint in CALM-1, it failed the primary endpoint in CALM-2 and missed important secondary measures across both
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One Phase 3 Win Wasn’t Enough: GSK’s Camlipixant Blockbuster Hope Collapses

Pharmaceutical QMS Software in 2026: eQMS Features, Compliance, and Validation

Explore how an electronic quality management system strengthens CAPA management, document control, audit trail review, and computerized system validation. This guide explains the core eQMS controls pharmaceutical companies need to maintain GMP compliance and improve inspection readiness.
  • Blog, Computerized System Validation
eQMS software for pharma dashboard supporting CAPA management, computerized system validation, audit trail review, and GMP inspection readiness.

FDA Speeds Reviews in 2026; AI and Old GMP Failures Put Approvals at Risk

Pharmaceutical manufacturing is entering a faster regulatory era. FDA is testing accelerated review models, companies are investing in artificial intelligence, and manufacturers are reconsidering where critical products should be produced. However, FDA’s latest quality data reveal an uncomfortable reality: faster
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FDA Speeds Reviews in 2026; AI and Old GMP Failures Put Approvals at Risk

India’s Drug Innovation Surges; BCG Warns 90-Day Trial Delays Could Stall Scale-Up

India’s life sciences sector has reached a critical turning point as local companies move beyond generics and develop novel drugs, CAR-T therapies, and AI-discovered molecules. However, a new report from Boston Consulting Group and HealthKois warns that weak clinical execution,
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India’s Drug Innovation Surges; BCG Warns 90-Day Trial Delays Could Stall Scale-Up

Novartis Wins Full FDA Approval for Fabhalta; 2-Year IgAN Data Confirm Slower Kidney Decline

Novartis has secured full US FDA approval for Fabhalta in adults with primary immunoglobulin A nephropathy who are at risk of disease progression. The regulator converted the drug’s accelerated approval into a traditional approval after two-year phase 3 data showed
  • News
Novartis Wins Full FDA Approval for Fabhalta; 2-Year IgAN Data Confirm Slower Kidney Decline

EMA–EISMEA Formalize 2026–2027 Program; Small Biotechs Face Late CMC Rework

The European Medicines Agency (EMA) and the European Innovation Council and SMEs Executive Agency (EISMEA) strengthened their cooperation on July 15, 2026. Their new 2026–2027 work program will help European health innovators understand regulatory expectations earlier. The initiative matters because
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EMA–EISMEA Formalize 2026–2027 Program; Small Biotechs Face Late CMC Rework

Risk Management Plan in Pharmacovigilance in 2026: EMA RMP and Safety Monitoring Guide

This guide explains how an EMA risk management plan supports safety specification, additional pharmacovigilance activities, and effective risk minimisation measures. It also shows how lifecycle updates help teams manage important identified risks and maintain a positive benefit-risk balance.
  • Blog, Quality Management System
Illustration of an EU risk management plan showing safety specification, important identified risks, lifecycle monitoring, and additional pharmacovigilance activities.