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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On June 24, 2022, the US Food and Drug Administration issued a draft guidance document on the Considerations for Rescinding Breakthrough Therapy Designation.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...
Rothwell, Figg, Ernst & Manbeck, P.C.
A recent appeal of a trademark application refusal shows the importance of filing proper specimens of use.
Goodwin Procter LLP
The Big Molecule Watch is monitoring pending legislation in Congress that relates to biosimilars and biologics. In this post, we check in on the status of two currently pending bills related to Citizen Petitions.
Goodwin Procter LLP
On July 26, Prestige Biopharma Limited ("Prestige") announced a partnership with Intas Pharmaceuticals Limited ("Intas") and its affiliate Accord Healthcare to commercialize Prestige's...
Goodwin Procter LLP
Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to ...
Arnold & Porter
Murad Hussain talks about how life sciences companies and healthcare providers can work with enforcement investigators to encourage a more sophisticated analysis of data.
Jones Day
On June 23, 2022, HHS-OIG issued Advisory Opinion No. 22-13, approving a financing arrangement between a DME manufacturer and two third-party financial institutions ("Lenders")...
Cooley LLP
Cooley handled 332 disclosable venture capital financing deals for Q2 2022, representing $16.6 billion of invested capital. Both numbers are down from Q1 2022, when Cooley handled 401...
Oblon, McClelland, Maier & Neustadt, L.L.P
On July 18 the Federal Circuit in Cardex, Inc. v. Eurofins Viracor, Inc., affirmed the district court decision finding that diagnostic method claims directed to detecting organ...
Arnold & Porter
In June 2022, the Office of the Inspector General (OIG) for the US Department of Health and Human Services (HHS) issued Advisory Opinion 22-14 regarding an ophthalmology practice's (Requestor) proposal...
Sheppard Mullin Richter & Hampton
The guidance also provides detailed format suggestions, including font size and type, letter case, and page layout and design.
Jones Day
Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health.
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