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Goodwin Procter LLP
We previously reported on Regeneron's antitrust suit against Amgen in the U.S. District Court for the District of Delaware. Amgen recently filed a motion to dismiss Regeneron's Complaint...
Oblon, McClelland, Maier & Neustadt, L.L.P
When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022)...
Goodwin Procter LLP
The Big Molecule Watch is monitoring clinical trial activities involving infliximab. Here we report on recent studies with Celltrion's INFLECTRA (infliximab-dyyb).
Proskauer Rose LLP
Not much, in itself. If one patent is good, 132 is probably fine too.
Venable LLP
The U.S. Consumer Product Safety Commission (CPSC) is an independent federal agency that regulates the manufacture, distribution, and sale of consumer products in the United States.
Goodwin Procter LLP
The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies.
Arnold & Porter
In March 2020, in response to the COVID-19 pandemic and associated health risks and travel restrictions, the Food and Drug Administration (FDA or the Agency) adjusted its field operations...
Duane Morris LLP
On July 28, the House of Representatives' Subcommittee on Biotechnology, Horticulture, and Research held a hearing to discuss ways in which the upcoming 2023 Farm Bill could improve...
Arnold & Porter
In our video series "Insights: Life Sciences," we examine the legal issues and trends impacting the life sciences and healthcare industries.
Sheppard Mullin Richter & Hampton
The UDI rules require all medical devices to bear a UDI on their labels and packaging, unless an exception or an alternative labeling method applies.
Goodwin Procter LLP
The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis.
Goodwin Procter LLP
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)1 has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury...
Sheppard Mullin Richter & Hampton
The United States' recent False Claims Act ("FCA") prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers...
Rothwell, Figg, Ernst & Manbeck, P.C.
On August 2, 2022, Coherus BioSciences announced that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable...
Goodwin Procter LLP
Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan's submission of an aBLA for M710, a proposed biosimilar of EYLEA (aflibercept).
Nexsen Pruet
On July 20, 2022, the Department of Health and Human Services Office of Inspector General (OIG) released a Special Fraud Alert addressing problematic arrangements observed...
Goodwin Procter LLP
On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab).
Cooley LLP
On June 24, 2022, the US Food and Drug Administration issued a draft guidance document on the Considerations for Rescinding Breakthrough Therapy Designation.
Jones Day
The Situation: Recent developments in the patent landscape of Clustered Regularly Interspaced Short Palindromic Repeats ("CRISPR")
Goodwin Procter LLP
President Biden's Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused...
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