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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

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.

Biogen’s Lowest Diranersen Dose Wins; Failed Dose Response Forces Phase III Rethink

Biogen has revealed mixed CELIA Phase II trial data for diranersen at AAIC 2026. The lowest 60 mg dose slowed clinical decline more than either 115 mg arm, although CELIA aimed to show greater benefit at higher doses. Consequently, the
  • News
Biogen’s Lowest Diranersen Dose Wins; Failed Dose Response Forces Phase III Rethink

Biogen’s Lowest Dose Wins; BIIB080’s Failed Dose Response Raises Phase 3 Risk

Biogen has reported detailed results from the Phase 2 CELIA trial for diranersen (BIIB080) in early Alzheimer’s disease. The drug reduced tau and slowed cognitive decline across several measures. However, the lowest dose produced the strongest effect, so the study
  • News
Biogen’s Lowest Dose Wins; BIIB080’s Failed Dose Response Raises Phase 3 Risk

Rechallenge in Pharmacovigilance in 2026: Causality Assessment and Drug Safety

This article explains how positive and negative drug rechallenge findings strengthen causality assessment, improve Individual Case Safety Report documentation, and support regulatory decision-making under WHO-UMC, Naranjo, EMA GVP Module VI, and ICH E2D frameworks worldwide.
  • Blog, Quality Management System
Drug safety specialist reviewing positive and negative rechallenge outcomes, adverse drug reaction data, and Individual Case Safety Report documentation.

Functional Unblinding Threatens Psychedelic Trial Credibility; FDA Guidance Could Force Phase III Redesigns

The US Food and Drug Administration (FDA) has finalized its guidance for clinical trials involving psychedelic drugs. The document covers trial design, participant safety, abuse potential, data collection, and preclinical work. The FDA and the Department of Health and Human
  • News
Functional Unblinding Threatens Psychedelic Trial Credibility; FDA Guidance Could Force Phase III Redesigns

Redi Health Reaches 9 of Top 10 Pharma Manufacturers; GxP Questions Follow

Nine of the world’s top 10 pharmaceutical manufacturers now use Redi Health to modernize patient support, according to a sponsored report published on July 13, 2026. The shift reflects demand for faster, more personalized patient experiences. However, it also places
  • News
Redi Health Reaches 9 of Top 10 Pharma Manufacturers; GxP Questions Follow

Dechallenge in Pharmacovigilance in 2026: Causality Assessment and Safety Signal Review

Explore how dechallenge in pharmacovigilance supports causality assessment, safety signal review, and regulatory reporting. Learn how positive dechallenge, negative dechallenge, and rechallenge findings help pharmaceutical teams evaluate adverse drug reactions and improve Individual Case Safety Reports.
  • Blog, Quality Management System
Pharmacovigilance causality assessment workflow showing adverse drug reaction evaluation, dechallenge outcomes, and Individual Case Safety Report review

FDA Rejected Utebzi; Now Spero Strikes a $1.1B Innovent Deal

Spero Therapeutics is shifting from antibiotics to immune and inflammatory diseases through a licensing agreement with Innovent Biologics worth up to $1.1 billion. The company will develop SP001, a CD40L antibody, outside China. At the same time, Spero secured $105
  • News
FDA Rejected Utebzi; Now Spero Strikes a $1.1B Innovent Deal