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STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work. Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid.

FDA 125
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Mapping the crisis: How data can help fix America’s growing pharmacy deserts

pharmaphorum

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Over-the-Counter Birth Control Pills: FDA Considering HRA Pharma’s Opill

Birth Control Pharmacist

In June 2022, the AMA urged the FDA to approve an OTC contraceptive method with no age restriction. In order for a drug to be approved for OTC use by the FDA, certain criteria must first be met. The next step is having a pharmaceutical company manufacture a product that can be FDA-approved for OTC use.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The original iteration of ISPE GAMP 5 was released in 2008 arriving in the nascent stages of what has become the cloud revolution and certainly before the widespread adoption of agile development methodologies, meaningful augmented reality, machine learning and artificial intelligence use cases in the life sciences industry. FDA, 2022. .

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Former Sanofi head Viehbacher to become Biogen CEO

pharmaphorum

Viehbacher led Sanofi between 2008 and 2014 and has decades of experience with both large pharmaceutical companies and small biotechs. A veritable ‘industry veteran’, he spent 20 years at GSK before Sanofi, where he helped reshape the company’s drug portfolio. — Bloomberg (@business) November 10, 2022. to $289.01

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

Gregory’s industrial career spans an employment history with several major pharmaceutical companies. IPQ International Pharmaceutical Quality. 2008; 364(2): 170–5. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. of Pharm Sci, 2017; 106(7), 1828-1838. Metz H, Mäder K. Int J Pharm.

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CMC Requirements for New Drug Registration in Latin America

ISPE

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. Modernization of the FDA CDER Export Certificate Program.”