In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods for treating cancer in a patient having a tumor that exhibits a high microsatellite instability (MSI-high) or a mismatch repair
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Fresenius and Formycon Receive EC and FDA Approval of Ustekinumab Biosimilar
On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI (ustekinumab-aauz), a biosimilar to STELARA®. FYB202/OTULFI is an interleukin-12 and interleukin-23 antibody and was approved for moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis,…
Aflibercept Biosimilar Updates in Europe
On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s aflibercept biosimilar AFQLIR. On September 20, 2024, Samsung and Biogen announced that the CHMP also adopted a positive opinion for their aflibercept biosimilar OPUVIZ. AFQLIR and OPUVIZ have been recommended for the…
Express Scripts Sues FTC Over Report on Pharmacy Benefit Management Industry
By Yoko Bian
On September 17, Express Scripts, Inc. (“Express Scripts”), one of the largest pharmacy benefit managers (PBMs) in the United States, brought suit against the Federal Trade Commission (“FTC”) over its July 2024 interim report on the PBM industry. Express Scripts claims that the FTC’s report, titled “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs…
NORD Annual Breakthrough Summit
In October, NORD will also hold its annual Breakthrough Summit in Washington, DC on October 20-22, 2024. This event draws over 1,000 attendees including patients/caregivers, patient advocacy organizations, and healthcare, biotech, and medical technology companies. Registration is available here. This year, Matt Wetzel will take part in a panel discussion on the growing role…
A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided…
Recent Biosimilar Approvals By the FDA
Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. As we previously reported, HERCESSI was approved earlier this year by the…
Preliminary Injunction Denied Against Amgen in Aflibercept BPCIA Litigation
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would prevent Amgen from launching PAVBLU…
Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide
On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product” classification. See Eli Lilly & Co. v. Becerra et al., No. 1:24-cv-01503 (S.D. Ind.). Lilly argues that the FDA improperly classified…
Down to the Wire: Resource Extraction Payments Disclosure Due
By David Lynn
In December 2020, the SEC adopted rules under the Dodd-Frank Act requiring that resource extraction issuers report payments made to foreign governments and the U.S. Federal government for the purpose of commercial development of oil, natural gas and minerals. These disclosures must be filed on Form SD.
The SEC established a transition period which specifies…