LATEST ARTICLES
United States
Foley & Lardner
On April 23, 2024, the U.S. Federal Trade Commission (FTC or "Commission") finalized a rule, by a vote of 3-2, abolishing the vast majority of employee covenants not to compete across...
Goodwin Procter LLP
On April 23, 2024, Alvotech announced "positive topline results from a confirmatory clinical study for AVT05," Alvotech's proposed golimumab biosimilar to Janssen Biotech, Inc.'s...
Kramer Levin Naftalis & Frankel LLP
On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product...
Bass, Berry & Sims
While healthcare mergers and acquisitions activity in the physician practice management (PPM) and hospital sectors appears to have slightly ticked up in Q1 compared to the last quarter of 2023...
Duane Morris LLP
The USPTO is soliciting comments regarding its proposed fee increases for fiscal year 2025. Written comments must be received on or before June 3, 2024, to ensure consideration.
Buchanan Ingersoll & Rooney PC
Recent reports from the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have brought to light a concerning development for those in the aesthetic...
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...
Marshall, Gerstein & Borun LLP
The IPO Law Journal recently published a paper titled "Patent Marking Regarding Software Medical Devices." The paper discusses an overview of patent marking-related case law...
Jones Day
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions.
Foley & Lardner
Foley's clients entrust our firm to look beyond the law to deliver holistic business solutions for their most challenging problems.
Axinn Veltrop & Harkrider
Two weeks ago we discussed Vanda Pharmaceuticals' ambitious cert petition asking the Supreme Court to discontinue the "reasonable expectation of success" standard for patent...
Venable LLP
On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon.
Mintz
Tom said, "Who knows how the court could decide. But I think it's important to note that they're trying to
essentially prevent total enforcement of the rule as a whole."
Goodwin Procter LLP
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson's STELERA® (ustekinumab).
Goodwin Procter LLP
As we previously reported, trial in Regeneron Pharmaceutical, Inc.'s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, "the Biocon Defendants")...
Goodwin Procter LLP
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation.
Exponent
On March 15, the Food and Drug Administration issued new draft guidance that impacts premarket submissions for all medical devices that produce temperature changes in patient tissues...
Worldwide
Arnold & Porter
On April 10, 2024, the European Parliament (EP) voted on its amendments to the European Commission's (EC) July 4, 2023 proposal for a GDPR Enforcement Regulation (the Proposal).
Arnold & Porter
This digest covers key virtual and digital health regulatory and public policy developments during March and early April 2024 from the United States, United Kingdom, and European Union.
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