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Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

The field of genomic medicine has reached a true turning point. In June 2022, the European Medicines Agency approved an adeno-associated viral (AAV) vector-based therapy for adults with Hemophilia A, making the treatment available to an estimated 3,200 eligible patients. [1] CEVEC became part of Cytiva in October 2022.

Genomics 244
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AvKARE Recall: Erectile Dysfunction Drug and Antidepressant Mistakenly Packaged Together

XTalks

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

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Opinion: Report: More people should be tested for potential exposure to ‘forever chemicals’

STAT News

A new report from the National Academies of Sciences, Engineering, and Medicine (NASEM) aims to change that. communities. Although researchers have known about the impact of these chemicals for years, there has been little guidance available for clinicians. Read the rest…

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FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

The Pharma Data

The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated. Families rely on stores like Family Dollar for products such as food and medicine.

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High Lead Levels in Cinnamon + Kaiser Permanente’s New Food Is Medicine Center – Xtalks Food Podcast Ep. 155

XTalks

Cinnamon can become contaminated with lead through various pathways. One primary source is the processing of cinnamon, including drying, grinding and packaging, which can introduce lead if the equipment or materials are contaminated. Subscribe to the Xtalks Food Podcast to never miss a new episode.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE).

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AvKARE Recall: Erectile Dysfunction Drug and Antidepressant Mistakenly Packaged Together

XTalks

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.