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Cell and gene therapy transactions carry unique risks for both licensor and licensee

Cell and gene therapy transactions have increased dramatically over the last few years, in both number and complexity, and have given rise to a number of issues that merit further...

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D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s...

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Restrictions on Lawyer Ads Involving Drugs and Medical Devices Are Not Unconstitutional, Says Federal Court

The Fourth Circuit has found that a West Virginia state law restricting how attorneys can solicit clients in pharmaceutical and medical device cases does not violate the First Amendment. At ...

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MDRP: CMS issues Manufacturer Release on multiple best prices reporting option for VBPs

Last week, the Centers for Medicare & Medicaid Services (CMS) issued Manufacture Release 116, available here, which provides technical guidance to manufacturers on the multiple best...

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FDA invites comment on guidance on meetings with OTC sponsors

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...

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FDA invites comment on guidance on meetings with OTC sponsors

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...

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Eleventh Circuit decision could significantly expand scope of orphan exclusivity

With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity ...

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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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