Drug Patent Watch

MARCH 12, 2025

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.

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Generic Drugs Drugs Manufacturing Branding 97

Camargo

OCTOBER 14, 2021

Appellate Court Ruling Impacts Orphan Drug Exclusivity. On September 30, the Eleventh Circuit Court of Appeals issued a decision reversing a district court ruling in a case involving orphan drug exclusivity. Container-closure changes. Senior Scientist, CMC Services. Dissolution microbiology (endotoxin testing).

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Development Packaging Packaging Generic Drugs 189

Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. Thousands of dedicated medical doctors, nurses, pharmacists, scientists, statisticians and other analysts are responsible for CEDR’s important work.

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Generic Drugs Manufacturing Drugs Regulation 68

Pharmaceutical Technology

OCTOBER 28, 2022

They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve.

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Bioequivalency Production Contamination Branding 130

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In 2022, Biktarvy generated $10.39 In 2022, Xgeva generated $2.01 Together, these two medications generated a total of €1.70

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Sales Manufacturing FDA Approval Life Science 98

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. WHO chief scientist, Soumya Swaminathan also expressed extreme skepticism of the new treatment’s benefits, stating that so far, there is little evidence to support the use of convalescent plasma for the treatment of COVID-19 infected patients. Drugs and Vaccines.

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Vaccine Vaccination Antibody Life Science 92