Business & Industry

Nitrosamine risk mitigation in global pharma manufacturing requires proactive control of chemical pathways, excipients, and operational practices to prevent trace-level carcinogenic impurities. Advanced analytics, rigorous risk assessments, and strengthened GMP frameworks are now essential to ensure long-term product safety and regulatory compliance.

As global pharmaceutical supply chains expand across diverse climates and sourcing regions, the risk of resilient fungal toxins entering drug products has intensified. Effective mycotoxins risk monitoring now demands proactive, data-driven oversight, advanced analytics, and integrated quality frameworks to protect patient safety at every stage of production.

Establishing a robust framework for regulatory success requires moving beyond fragmented information silos toward a unified, digital-first approach. Comprehensive oversight of the pharmaceutical lifecycle depends on the ability to transform raw information into actionable insights, ensuring that every data point contributes to a larger narrative of safety and efficacy. By prioritizing specialized platforms that aggregate and organize complex information, organizations can achieve a level of transparency that satisfies the most stringent global standards while fostering a culture of continuous improvement.

Johnson & Johnson announced that it plans to invest more than $1 billion to construct a new cell therapy facility in Pennsylvania. The move forms part of the company’s broader strategy, unveiled last year, to expand its U.S. manufacturing...

Johnson & Johnson (J&J) has obtained approval from the US Food and Drug Administration (FDA) for a revised dosing schedule of Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), introducing a once-monthly administration option for patients with advanced, epidermal growth factor receptor...

In a move that is sure to create a stir within the Asia pharma circle, Sanofi Healthcare India - SHIPL is going ahead and expanding its GCC- global capability centre in Hyderabad, Telangana State with another 2.7 lakh sq.ft....

Gilead Sciences has added another synthetic lethal asset to its oncology portfolio, agreeing to pay $80 million upfront to obtain global rights to a clinic-ready cancer therapy from China-based Genhouse Bio. Headquartered in Suzhou, Genhouse Bio has been advancing its...