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Sheppard Mullin Richter & Hampton
The Biden administration recently determined that it has the right to seize patents covering certain high-priced medicines, in an apparent effort to take a more aggressive approach to lowering drug prices.
Mintz
Rachel said, "Despite the case being the first to reach a circuit court among the several lawsuits fighting the program, the issues on appeal are ‘unique' to NICA and will have relatively little impact on the other cases.
Bass, Berry & Sims
Demand for cannabidiol (CBD) products continues to climb, and the market has risen to the occasion. There is now a robust array of foods, oils, lotions, capsules and cosmetics...
McGlinchey Stafford
At the White House last Friday, Vice President Kamala Harris spoke at a meeting with people who received pardons from President Joe Biden for marijuana-related offenses.
Proskauer Rose LLP
On Thursday, April 18, the Department of Justice ("DOJ"), the Federal Trade Commission ("FTC"), and the Department of Health and Human Services...
Perkins Coie LLP
USDA's Agricultural Marketing Service (USDA-AMS) recently published a Request for Information soliciting stakeholder input on the electronic or digital link disclosure option for bioengineered...
Kramer Levin Naftalis & Frankel LLP
On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product...
Bass, Berry & Sims
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements...
Akin Gump Strauss Hauer & Feld LLP
The upcoming election, and the approaching end of the President's four-year term, introduce additional dynamics into the agencies' rulemaking process and even the guidance process.
Venable LLP
According to an April 2024 press release, Alvotech and Teva's Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson's Stelara® (ustekinumab).
Foley & Lardner
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage...
Foley & Lardner
The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing...
Crowell & Moring LLP
As reported in an earlier Client Alert, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration's "Approved Drug Products...
Sheppard Mullin Richter & Hampton
On April 2, the FDA issued a warning letter to Agena Bioscience Inc., alleging its product, intended for research use only (RUO)...
AlixPartners
AlixPartners recently collaborated with the American Frozen Food Institute (AFFI) to publish a "How to Win in Frozen" playbook, a landmark study on the state of the department.
Greenberg Traurig, LLP
New York liquor license applicants, take note: The Fiscal Year 2025 New York State Budget enacted on April 20, 2024, contains several provisions affecting you.
Barnes & Thornburg
On April 8, the U.S. Department of Health and Human Services' Office of Inspector General (HHS-OIG) released Advisory Opinion No. 24-02, a favorable opinion regarding patient assistance programs (PAPs)...
WilmerHale
Prost, J. The Court affirmed the district court's indefiniteness determination but vacated and remanded its nonobviousness determination as to the asserted patent.
Mintz
Madison said, "Looking at the historical context of why pregnant women are excluded from these studies is important,"
referencing a period when the use of thalidomide by pregnant people to treat nausea...
Goodwin Procter LLP
As we previously reported, the U.S. Department of Justice ("DOJ") filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts...
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