Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Request an appointment now

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

ICSR in Pharmacovigilance in 2026: Case Processing, E2B(R3), Reporting Timelines, and Compliance Guide

Explore how safety teams manage ICSR validity, day zero, MedDRA coding, seriousness assessment, E2B(R3) reporting, follow-up, and duplicate cases. This guide also explains reporting timelines, inspection evidence, and the controls needed for reliable pharmacovigilance compliance.
  • Blog, Quality Management System
Pharmacovigilance dashboard showing ICSR validity criteria, seriousness assessment, duplicate case management, reporting timelines, and EudraVigilance submission controls.

Pfizer Beats Earnings, Adds $2.5B in Cuts; GxP Teams Must Reassess Change Control

Pfizer reported stronger-than-expected second-quarter results on August 4 in New York and added $2.5 billion to its cost-reduction plan. The company now expects $9.7 billion in net savings through 2029 while raising the midpoint of its 2026 revenue outlook. This
  • News
Pfizer Beats Earnings, Adds $2.5B in Cuts; GxP Teams Must Reassess Change Control

Amgen Drops AMG-513; Ending Development Does Not End Safety Oversight

Amgen announced on August 4 in Thousand Oaks, California, that it will end future development of AMG-513, its early-stage obesity candidate. However, the company will keep the Phase 1 trial running until enrolled participants complete follow-up. The decision matters because
  • News
Amgen Drops AMG-513; Ending Development Does Not End Safety Oversight

Pharmacovigilance System Master File in 2026: PSMF Requirements, EU GVP Module II, QPPV, and Inspection Readiness

Explore PSMF requirements, structure, maintenance, and inspection readiness under EU GVP Module II. This article explains QPPV responsibilities, annex control, computerised systems, audit evidence, and change management practices that help drug safety teams prepare for regulatory inspections.
  • Blog, Quality Management System
PSMF structure showing QPPV responsibilities, safety data systems, PSMF annexes, quality controls, audits, and inspection-ready documentation.

Merck Raises Revenue Outlook; $14.7 Billion Deals Heighten Quality Integration Demands

Merck raised its 2026 revenue forecast after reporting stronger second-quarter sales on August 4 at its headquarters in Rahway, New Jersey. However, the company sharply reduced its adjusted earnings guidance because of charges linked to its acquisitions of Terns Pharmaceuticals
  • News
Merck Raises Revenue Outlook; $14.7 Billion Deals Heighten Quality Integration Demands

Sarepta Names New CEO After 90% Crash; Can FDA Trust Recover From Patient-Death Fallout?

Sarepta Therapeutics appointed former Tessera Therapeutics chief Michael Severino as CEO, effective July 28, 2026, after a turbulent period marked by gene therapy safety concerns, regulatory conflict and a stock decline of nearly 90% from early 2025. The leadership change
  • News
Hook: Data/Stats + Crisis + Authority + Curiosity Gap

AstraZeneca–BMS $400B Merger Talks; Could GxP Integration Trigger a Quality Crisis?

AstraZeneca and Bristol Myers Squibb have reportedly discussed a potential combination that could value the new group at nearly $400 billion. The talks remain preliminary, and neither company has announced a transaction. However, its scale and overlapping oncology portfolios matter
  • News
AstraZeneca–BMS $400B Merger Talks; Could GxP Integration Trigger a Quality Crisis?

Medical Device Registration in Europe in 2026: EU MDR, CE Marking, EUDAMED, and Market Access Guide

Explore the EU regulatory pathway for medical devices, including classification, conformity assessment, CE marking, EUDAMED registration, UDI controls, and notified body review. Learn which records reviewers cross-check and how manufacturers can maintain EU MDR compliance after market entry.
  • Blog, Medical Devices
Medical device compliance workflow showing CE marking, technical documentation, Unique Device Identification UDI, notified body review, and EUDAMED registration in the European Union.