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Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

Goodwin on

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

Jones Day

NIH Seeks Comments on Patient Access Plan Requirements in Patent License Agreements

Jones Day on

The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more

Knobbe Martens

Pfizer Australia Announces Deal to Acquire ResApp Health

Knobbe Martens on

ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more

Jones Day

California Closing in on Licensure Requirements for ACOs and Other Risk-Bearing Entities

Jones Day on

California's Department of Managed Health Care ("DMHC") has proposed regulations that could require accountable care organizations ("ACOs") and other entities that assume "global risk" to obtain licensure as a health care...more

Knobbe Martens

Mechanical Ventilation Innovation Challenge

Knobbe Martens on

According to press releases, the American Association for Respiratory Care (AARC) and Edison Nation Medical have partnered to search for innovations for improving the process, outcomes, and comfort for patients requiring...more

Tucker Arensberg, P.C.

CMS Proposes New Stark Exceptions: Timeshare Lease

Tucker Arensberg, P.C. on

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. Over the next few days, I will post comment on what I consider the most significant new...more

Baker Donelson

IRS Ruling Addresses Application of Medical Device Excise Tax in Contract Manufacturing Arrangement

Baker Donelson on

In Private Letter Ruling 201420004 (released May 16, 2014), the Internal Revenue Service (IRS) has ruled on the question of which party in a contract manufacturing arrangement is the "manufacturer" for purposes of the medical...more

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