European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

European Pharmaceutical Review

JANUARY 16, 2023

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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Food and Drug Administration FDA Manufacturing Food 122

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

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Food and Drug Administration FDA Manufacturing Product sample 105

PM360

AUGUST 26, 2024

Now, precision medicine needs an overhaul. During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285. Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers.

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Medicine Food and Drug Administration Government Insurance 52

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

Pharmaceutical Technology

APRIL 18, 2023

The investment at the LEAP site marks the company’s biggest manufacturing investment at a single location to date. The new facilities will also support the company’s efforts to manufacture new therapeutic modalities, including genetic medicines. Last year, the company committed to providing $42.5m

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Manufacturing Food and Drug Administration Pharmaceutical manufacturing Medicine 52

European Pharmaceutical Review

DECEMBER 18, 2023

At the beginning of this year, EPR reported on the potential blockbuster pharmaceutical drugs to watch in 2023. Additionally, in October, EPR shared Phase III trial data for the type 1 diabetes treatment TZIELD (Teplizumab), which suggested that the medicine could slow disease progression.

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Manufacturing Food and Drug Administration Medicine Pharmaceutical manufacturing 98