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Pharmaceutical Industry › Consent Decrees

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

Goodwin on

While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Barnea Jaffa Lande & Co.

ICA Request for Information: Foreign Company Fined

Barnea Jaffa Lande & Co. on

The Israeli Competition Director General recently announced he had reached an agreement with the British pharmaceutical company Leadiant Biosciences. According to the agreement, Leadiant undertook to pay ILS 110,000 to the...more

Ankura

Pharma Companies Can Ensure Data Integrity With User Access Management (UAM)

Ankura on

Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more

Goodwin

Antitrust + Competition Life Sciences Quarterly Update - Q1 2022

Goodwin on

Despite the aggressive rhetoric, the change in the leadership and composition at the U.S. Federal Trade Commission (FTC) did not result in more enforcement in 2021. As the calendar turned to 2022, the FTC seems to be stepping...more

McDermott Will & Schulte

Corporate Law & Governance Update - March 2019

McDermott Will & Schulte on

NEW AG ACTION FOCUSES ON CHARITABLE PURPOSES - New legal action by the Pennsylvania Attorney General against a prominent nonprofit health system is grounded in allegations of violation of charitable purposes. The...more

Hogan Lovells

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

Hogan Lovells on

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good...more

Cozen O'Connor

The State AG Report Weekly Update September 2018 #1

Cozen O'Connor on

2018 AG Elections- Massachusetts Democratic and Republican Parties Hold Primary Elections- Massachusetts held statewide primary elections on September 4, 2018....more

Cozen O'Connor

The State AG Weekly Update

Cozen O'Connor on

2018 AG Elections- North Dakota Attorney General Wayne Stenehjem Announces Bid for Reelection- North Dakota AG Wayne Stenehjem declared his intention to run for reelection to a sixth term in 2018. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

Skadden, Arps, Slate, Meagher & Flom LLP on

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

McGuireWoods LLP

IRS Informally Rules Disgorgement Payments Under FDA Consent Decree May Be Deductible

McGuireWoods LLP on

In Internal Revenue Service Field Attorney Advice released May 22, 2015 (FAA 20152103F), the IRS Office of Chief Counsel expressed its informal view that the evidence suggests that the amount the taxpayer paid the United...more

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