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MDRP multiple best prices option and territory exclusion update plus Part B discarded drug refund

While Congress continues to consider significant drug pricing legislation, separate regulatory and statutory changes have been finalized this week with potential implications for...

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U.S. House passes drug pricing legislation

This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s...

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New proposed privacy rules for global companies conducting business in Australia

The Australian Government has released draft legislation aimed at ensuring Australia’s privacy law remains well equipped to tackle the next digital era.

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COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....

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MDRP and 340B: Updates from last week

On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on...

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Hybrid products and registration in the generics register ("répertoire des groupes génériques")

The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic.

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FTC reinforces breach notification duties for health apps and connected health and wellness devices

A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be...

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COVID-19 Report for Life Sciences and Health Care Companies (October 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

News

Revision of the EU general pharmaceuticals legislation – public consultation is now open

The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This initiative is part of the EU Pharmaceutical...

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