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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

GSK Moves 1,000 Scientists: Cambridge Relocation Puts Validation Under Pressure

GSK announced a £400 million plan on July 28, 2026, to establish a 300,000-square-foot global R&D centre on the Cambridge Biomedical Campus. The company plans to move more than 1,000 UK scientists to Cambridge, leave its Stevenage R&D site through
  • News
GSK Moves 1,000 Scientists: Cambridge Relocation Puts Validation Under Pressure

FDA Proposes One Registration: Can Quality Systems Control Every Manufacturing Unit?

The FDA proposed a new registration pathway on July 10, 2026, for distributed manufacturing networks that operate through a hub-and-spoke model. If finalized, the FDA distributed manufacturing rule would let qualifying networks register as one establishment instead of registering every
  • News
FDA Proposes One Registration: Can Quality Systems Control Every Manufacturing Unit?

Medical Device Registration in 2026: Complete Guide to FDA, EU MDR, and Global Compliance

This guide explains how manufacturers manage device classification, FDA listing, EU MDR conformity assessment, CE marking, UDI, EUDAMED, technical documentation, and post-market controls to reduce registration delays, inspection findings, and global market-access risks throughout the product lifecycle.
  • Blog, Medical Devices
Medical devices, technical documentation, UDI labels, and compliance records illustrating FDA medical device registration, EU medical device registration, and global approval requirements.

Argenx Bets $2.2B Before Phase 2 Data, FB102 Faces Its Biggest Test

Argenx has agreed to acquire Forte Biosciences for approximately $2.2 billion, placing a major bet on FB102 before its key Phase 2 celiac disease results arrive. The deal gives argenx a first-in-class anti-CD122 antibody with early signals in celiac disease
  • News
Argenx Bets $2.2B Before Phase 2 Data, FB102 Faces Its Biggest Test

C Square Pharma Software in 2026: ERP Solutions for GMP Compliance

Explore how pharma ERP software supports batch tracking, expiry management, data integrity, audit trails, and computer system validation across pharmaceutical distribution. The article also explains implementation risks, inspection evidence, and why software alone cannot guarantee GMP or GDP compliance.
  • Blog, Computerized System Validation
Pharmaceutical inventory management software dashboard showing batch tracking, expiry management, audit trails, user access, and distribution controls in a regulated facility.

Capricor Called HOPE-3 a Success, FDA Says Deramiocel Evidence Falls Short

Capricor Therapeutics shares plunged about 65% on Monday after FDA reviewers questioned whether deramiocel benefits patients with Duchenne muscular dystrophy. The agency released its assessment before a July 29 advisory committee meeting. Although Capricor calls HOPE-3 Phase 3 study positive,
  • News
Capricor Called HOPE-3 a Success, FDA Says Deramiocel Evidence Falls Short

Koerber Pharma Software in 2026: PAS-X, MES, and GMP Compliance Guide

Explore how PAS-X MES supports electronic batch records, production control, and data integrity in regulated pharmaceutical manufacturing. Learn which validation, access, audit trail, and lifecycle controls inspectors expect under 21 CFR Part 11 and EU GMP Annex 11.
  • Blog, Validation and Qualification
Pharmaceutical MES software interface showing PAS-X MES controls for electronic batch records, audit trails, electronic signatures, and batch release.

Ivonescimab Beat Keytruda in China; Could It Still Fail FDA’s Test?

Summit Therapeutics and China-based Akeso have reported new Western data for ivonescimab, their PD-1/VEGF-targeting lung cancer antibody. The findings suggest that the drug’s efficacy may extend beyond Chinese patients. However, the case highlights a wider regulatory problem: strong Phase 3
  • News
Ivonescimab Beat Keytruda in China; Could It Still Fail FDA’s Test?