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Innovations and highlights in the Pharma industry 

Dive deep into the world of Pharma with Zamann’s Expert Blog. Our industry-leading professionals share insights on global project management, quality consultancy, digitalization, and more. Stay updated with trends and innovations transforming the Pharma industry. 

News and more

ISO 9001 in Pharma Industry in 2026: Requirements, GMP Compliance, ICH Q10, and Certification Guide

Explore how ISO 9001 certification supports pharmaceutical quality management, complements GMP compliance and ICH Q10, and strengthens risk management, CAPA, documentation, and continual improvement. Learn what auditors review and which evidence matters most during quality-system assessments.
  • Blog, Quality Management System
Pharmaceutical quality management system showing GMP compliance, quality risk management, CAPA, and inspection-ready documentation.

EMA Updates Shortage Plans; MAHs Get Just Two Days to Respond

The European Medicines Agency (EMA) has updated its guidance on shortage prevention plans for medicines marketed in the EU, ahead of new legal requirements expected by mid-2027. The update matters because marketing authorisation holders (MAHs) must identify supply-chain vulnerabilities, classify
  • News
EMA Updates Shortage Plans; MAHs Get Just Two Days to Respond

FDA Approves Moderna’s mRNA Flu Vaccine; Phase IV Now Determines Senior Evidence

The FDA approved Moderna’s mFlusiva on August 6, 2026, making it the first mRNA-based influenza vaccine authorized in the United States. The agency granted traditional approval for adults aged 50 to 64 but used accelerated approval for those 65 and
  • News
FDA Approves Moderna’s mRNA Flu Vaccine; Phase IV Now Determines Senior Evidence

FDA Rejected Tudriqev Twice; Accelerated Approval Shifts Proof to Phase III

The FDA granted accelerated approval to Replimune’s Tudriqev with nivolumab on August 6, 2026, for advanced melanoma after anti-PD-1 therapy. The decision is significant because FDA had previously rejected the application twice over efficacy concerns. For Regulatory Affairs and clinical
  • News
FDA Rejected Tudriqev Twice; Accelerated Approval Shifts Proof to Phase III

FDA’s Phase 1 CMC Reset; Sponsors Could Save Up to 12 Months

FDA will use an August 6 webinar to explain its proposed Expedited IND Pilot Program, which aims to shorten the path from drug identification to first-in-human trials. The agency wants sponsors to work with qualified research institutions and use rolling
  • News
FDA’s Phase 1 CMC Reset; Sponsors Could Save Up to 12 Months

ICH Guidelines for Pharmacovigilance in 2026: E2A–E2F, ICSR Reporting, PBRER, and Risk Management

Explore how the ICH E2 series connects expedited safety reporting, electronic ICSR transmission, PBRERs, DSURs, and pharmacovigilance planning. This guide also explains regional implementation, inspection evidence, and the controls needed to maintain reliable safety operations.
  • Blog, Quality Management System
Pharmaceutical compliance dashboard showing ICH E2B R3 data exchange, individual case safety reports, periodic benefit-risk evaluation, DSUR preparation, and inspection evidence.

FDA’s Retatrutide Decision; Lilly Could Lose 7 Years of Market Exclusivity

Eli Lilly’s retatrutide biologic dispute with the FDA has reached a critical point before a planned first-quarter 2027 filing. Lilly intends to pursue a Biologics License Application (BLA), while FDA has classified retatrutide as a drug requiring a New Drug
  • News
FDA’s Retatrutide Decision; Lilly Could Lose 7 Years of Market Exclusivity

Novo CEO Says Innovation Is Survival; ZEUS Failure Raises Evidence Bar for Pipeline Decisions

Novo Nordisk CEO Mike Doustdar said during the company’s August 5 earnings call that innovation will determine whether the Danish drugmaker can sustain long-term growth. His comments followed the Phase 3 ZEUS trial failure for ziltivekimab and other pipeline setbacks.
  • News
Novo CEO Says Innovation Is Survival; ZEUS Failure Raises Evidence Bar for Pipeline Decisions