2028 Biosimilars Regulations 
The Pharma Data
APRIL 6, 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S.
The Pharma Data
APRIL 8, 2021
persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.
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FDA Law Blog: Biosimilars
OCTOBER 6, 2023
The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
FDA Law Blog: Biosimilars
DECEMBER 3, 2023
CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. CMS also intends to implement a compliance monitoring program through future regulations or guidance. Sunsetting of Coverage Gap Discount Program: The 70% coverage gap discount under the CGDP will continue until December 31, 2024.
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