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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

Pharma Legislation in 2026: Drug Approval, GMP Requirements, Pharmacovigilance, and Global Compliance Guide

Explore how pharmaceutical regulations shape drug development, marketing authorization, GMP requirements, and pharmacovigilance across major markets. This guide explains global regulatory frameworks, approval pathways, compliance expectations, and inspection readiness for pharmaceutical companies operating under changing regulatory requirements.
  • Blog, Quality Management System
Global pharmaceutical regulatory framework showing GMP regulations, marketing authorization, regulatory authorities, and compliance monitoring.

27,000 Chemotherapy Vials Recalled; Discoloration Complaints Trigger Nationwide Recall

Shilpa Medicare is voluntarily recalling more than 27,000 vials of Pemetri RTU chemotherapy drug in the United States after market complaints reported green to dark-green discoloration in certain vials. The nationwide action involves two strengths and has been classified by
  • News
27,000 Chemotherapy Vials Recalled; Discoloration Complaints Trigger Nationwide Recall

FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path

Capricor Therapeutics plans to amend its BLA for deramiocel after an FDA advisory committee voted 9–3 against finding substantial evidence of effectiveness for Duchenne muscular dystrophy cardiomyopathy. During its August 13 earnings call, the company said the amendment will add
  • News
FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path

Regulatory Specialist in 2026: Role, Skills, Qualifications, Salary, and Pharma Career Path

A Regulatory Specialist connects regulatory submissions, GMP compliance, change control, and inspection readiness across the pharmaceutical lifecycle. This guide explains the role, essential skills, qualifications, salary factors, and career path for professionals working in pharmaceutical regulatory affairs.
  • Blog, Quality Management System
Pharmaceutical regulatory affairs professional reviewing regulatory submissions, change control records, and inspection readiness documentation.

BioNTech Pushes 25+ Oncology Trials Forward; Validation Readiness Becomes the Commercial Test

BioNTech has appointed Guido Oelkers as its next CEO as the German biotech prepares for a decisive return to oncology. Oelkers will take office by February 1, 2027, at the latest, inheriting falling COVID-19 vaccine sales, a deep cancer pipeline
  • News
BioNTech Pushes 25+ Oncology Trials Forward; Validation Readiness Becomes the Commercial Test

Pharma Trust Starts Before PR; GMP Compliance Becomes the Real Test

Pharmaceutical Executive examined how leading drugmakers build and measure trust across their organizations and found that the foundation starts before reputation, ESG, or public communication. It starts with safe, effective, high-quality medicines and genuine regulatory compliance. The analysis matters for
  • News
Pharma Trust Starts Before PR; GMP Compliance Becomes the Real Test

Halo Launches Sterile Fill-Finish: GMP Qualification Becomes Its Next FDA Milestone

Halo Pharma is preparing to launch a new sterile fill-finish platform in the United States, marking its first move into syringe, vial, and cartridge filling. The expansion responds to demand for domestic injectable capacity, while the Apotex partnership gives Halo
  • News
Halo Launches Sterile Fill-Finish: GMP Qualification Becomes Its Next FDA Milestone

Medical Device Regulatory Submissions in 2026: 510(k), De Novo, PMA, eSTAR, and FDA Approval Guide

Explore how FDA medical device submissions work across 510(k), De Novo, PMA, and eSTAR pathways. Learn how classification, predicate strategy, evidence planning, substantial equivalence, and quality documentation can support smoother premarket review and stronger regulatory readiness.
  • Blog, Medical Devices
Medical device premarket submission workflow showing eSTAR submission, predicate device comparison, substantial equivalence, and FDA premarket review.