The Pharma Data
JULY 29, 2021
Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
Pharma in Brief
AUGUST 9, 2021
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,
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XTalks
FEBRUARY 8, 2021
In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.
XTalks
AUGUST 2, 2023
In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. It is a dipeptidyl peptidase-4 inhibitor that keeps insulin levels stable and reduces the amount of glucose produced by the body. Merck’s total global revenue from Lagevrio was $5.68
Pharmacy Checkers
MARCH 11, 2020
The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. for drug safety. counterparts. J)(2) Waiver authority.
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