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FDA completes inspection of Nexus’ manufacturing facility in US

Pharma Leaders

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticalspharmaceutical 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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PhRMA lies to protect pharma profits

World of DTC Marketing

In 2021 alone, the top U.S. pharmaceutical companies booked tens of billions of dollars in revenue: Johnson & Johnson ($94 billion), Pfizer ($81 billion), AbbVie ($56 billion), Merck & Co. ($49 First, let’s clarify how the bill saves taxpayers billions. 49 billion), and Bristol Myers Squibb ($46 billion). . ($49

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FDA warning letters highlight data integrity issues

European Pharmaceutical Review

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. References Warning Letters.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

Pharmaceutical manufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions. 2(1)(B)(i) (2021), [link] senate-bill/562/text.

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Everything You Need to Know About Market Access in China

PM360

At the same time, a “drug lag” persists in China for global pharmaceutical companies’ products. Between 2017 and 2021, the median time difference between the first global approval and the approval in China was five years 1. In 2021, the out-of-pocket (OOP) cost accounts for 28% of the whole healthcare expenses compared to 15.4%

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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1] Manufacturers, healthcare providers, and consumers alike face the need to quickly adapt. 2021 Sep 8;18(18):9465.

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Pharmaceutical Patents: A Challenge for Malaysia

Contrarian Sales Techniques

It is noteworthy that Malaysia has a pharmaceutical manufacturing sector that almost exclusively produces generic drugs, with sales revenues amounting to only 1.5% According to Zion Market Research, the global generic market is growing at more than 10 percent per year and is expected to reach approximately $380 billion by 2021.