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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

In the EU, a joint PFAS Restriction Proposal under REACH was submitted, aiming for a full ban by 2028/2030. billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. There is worldwide concern around the use of PFAS.

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European regulators prepare for AI in pharma

European Pharmaceutical Review

The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

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MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

billion in 2028. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials. In 2022, the company reported Keytuda sales of $20.9 billion in its FY 2022 results. GlobalData is the parent company of Pharmaceutical Technology.

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USP General Chapter —Glass revised

European Pharmaceutical Review

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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Eric Halioua, President & CEO at PDC*line Pharma Shares Insights on the Results from P-I/II Trial with PDC*lung01

PharmaShots

These new results reinforce our differentiating data package for PDC*lung01. After the completion of the current clinical study with PDC*lung01 (PDC-LUNG-101), we plan to conduct a randomized, open-label phase 2 clinical trial with PDC*lung in the B2 cohort setting (2025 to 2028).