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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?

Novogene Expands Single-Cell Sequencing; Can Validation Control the Data Chain?

Novogene Europe has expanded its single-cell RNA sequencing capability at the Cambridge Omics Centre in the UK. The new service brings advanced 10x Genomics Chromium workflows closer to academic, biotech and biopharma researchers. While the expansion can accelerate biomarker research
  • News
Novogene Expands Single-Cell Sequencing; Can Validation Control the Data Chain?

BeOne Adds $300M in US Manufacturing; GMP Readiness Could Decide Its 2029 Launch

BeOne Medicines is investing another $300 million in its Princeton West Innovation Campus in Hopewell, New Jersey, taking its total investment in the site beyond $1 billion. The expansion will add a three-storey, 145,000-square-foot building for small-molecule drug product manufacturing,
  • News
BeOne Adds $300M in US Manufacturing; GMP Readiness Could Decide Its 2029 Launch

6 Sigma Software in Pharma in 2026: Digital Tools for Quality Improvement

Explore how Six Sigma software supports DMAIC, process capability analysis, root cause investigations, and CAPA effectiveness across regulated pharmaceutical operations. The article explains the controls quality teams need to create reliable data, defensible decisions, and inspection-ready evidence.
  • Blog, Computerized System Validation
Pharmaceutical quality specialist reviewing control charts, process capability analysis, CAPA effectiveness, and DMAIC methodology on a digital dashboard in a modern manufacturing laboratory

FDA Panel Backs Four Peptides; Scientists Still Question Their Identity

An FDA advisory committee has narrowly supported adding BPC-157, KPV, TB-500, and MOTS-c-related substances to the list of bulk ingredients that may be used by eligible 503A compounding pharmacies. The decision could reshape access to peptides already promoted across wellness
  • News
FDA Panel Backs Four Peptides; Scientists Still Question Their Identity

FDA Weighs Tavneos Withdrawal; Amgen’s Reanalysis Fails to Confirm Week-52 Superiority

Amgen has submitted a new evidence package to defend Tavneos and request an FDA hearing. However, the dispute no longer focuses only on whether the drug can help patients with ANCA-associated vasculitis. The regulator now questions whether the pivotal ADVOCATE
  • News
FDA Weighs Tavneos Withdrawal; Amgen’s Reanalysis Fails to Confirm Week-52 Superiority