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After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820...
Polsinelli LLP
On February 6, 2024, the Federal Trade Commission ("FTC") commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act...
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings...
Crowley Law LLC
Last week I had the opportunity to attend the BioMedical Engineering Day at Stevens Institute of Technology in Hoboken, New Jersey.
K&L Gates
From 2018 to 2022, Pennsylvania was outspent on economic development incentives by neighboring states in both total incentive spending and average deal size. Over the same period...
Greenberg Traurig, LLP
In its latest global regulatory harmonization effort, on Feb. 2, 2024, the FDA published a final rule amending the cGMP requirements for medical devices contained in the QSR...
Arnold & Porter
On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation...
Ropes & Gray LLP
On February 2, 2024, the U.S. Food and Drug Administration ("FDA") published a final rule1 to amend the current good manufacturing practice requirements...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
In Acadia Pharms., Inc. v. Aurobindo Pharma Ltd., No. 20-985-GBW (D. Del. Dec. 2023), the district court granted Acadia's motion for summary judgment of no invalidity...
Hyman, Phelps, & McNamara
As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in late December.
Goodwin Procter LLP
On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. ("Regeneron") filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the alternative, an emergency status conference.
Foley & Lardner
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services, announced a final rule...
McGuireWoods LLP
The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 CFR 820.
Arnold & Porter
On February 2, the U.S. Food and Drug Administration (FDA or the Agency) published the Agency's much anticipated final rule amending the medical device Quality System Regulation...
Goodwin Procter LLP
On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI from Coherus BioSciences, Inc. for an upfront cash purchase payment of USD 170 million.
Crowell & Moring LLP
On January 30, the Centers for Medicare & Medicaid Services' (CMS') Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT)...
Goodwin Procter LLP
Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office's statistics portal, as of January 30, 2024...
Goodwin Procter LLP
On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab...
Winston & Strawn LLP
The Southern District of New York's recent opinion in the In re Acetaminophen MDL establishes strong guardrails regarding how expert witnesses can rely on studies and data in support of their opinions.
Axinn Veltrop & Harkrider
In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing...
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