European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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pharmaphorum

DECEMBER 28, 2022

So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness? Any purchasing company would ideally like to integrate their acquisitions into their company seamlessly. She joined NSF in 2017.

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ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings. These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

The People's Pharmacy

MAY 8, 2023

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S. What is extraordinary about this scandal is that the FDA inspected one of the Ranbaxy facilities in 2004. Carcinogens in Blood Pressure Meds?

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ISPE

MARCH 7, 2023

A collaborative mindset must prevail between pharmaceutical companies, suppliers, and regulators and include strategic partnerships that go beyond the pharmaceutical sector so we can move together to a more sustainable future. The risks are equally applicable to both privately owned and publicly traded companies.

Health and Personal Care Stores 52

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