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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.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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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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Amarin Makes Moves towards Global Expansion of Vazkepa

Pharmaceutical Technology

The pharmaceutical company is well on its way to achieving its goals with successful full reimbursements, already confirmed in the United Kingdom ( UK), and Sweden. AstraZeneca ’s cholesterol drug Crestor (rosuvastatin) was approved in 2003 in the US but only approved in Germany in 2008.

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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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Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. The exact mechanism of action is uncertain.

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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. .