Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together,...more
On January 30, 2026, the Court ordered Genentech / Hoffmann-La Roche and Shanghai Henlius Biotech / Organon’s stipulated dismissal of Case No. 2:25-cv-14648 (D.N.J.) due to a settlement agreement between the parties. ...more
On January 21, 2026, as part of an earnings call, Dr. Reddy’s announced the filing of an aBLA for an intravenous (IV) formulation of DRL_AB (abatacept), a proposed biosimilar of Bristol-Myers Squibb’s Orencia® (abatacept) in...more
On January 19, 2026, Hikma announced the launch of Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), following their FDA-approval in September 2025. ...more
Many Prolia®/Xgeva® (denosumab) biosimilars approved in 2025 by FDA and EMA. FDA grants first interchangeable status for rapid acting insulin aspart, KristyTM....more
On Friday, the Supreme Court granted certiorari in Hikma Pharmaceuticals v. Amarin Pharma, ending an almost three-year lull in patent cases at the Court. The case presents two related questions, one framed specifically in the...more
On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the landscape of generic drug competition and patent enforcement....more
On December 19, 2025, the FDA approved Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) as the nineth biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
On November 20, 2025, the FDA approved Accord’s Osvyrti® and Jubereq® (denosumab-desu), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
On November 13, 2025, the FDA approved Shanghai Henlius Biotech / Organon’s Poherdy® (pertuzumab-dpzb) as the first interchangeable biosimilar of Genentech’s Perjeta® (pertuzumab). Poherdy® is approved for all of the same...more
On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in...more
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and children aged 6...more
In this era of industrialized capitalism, there are serious economic incentives to promote products in nascent industries. Intellectual property and the corresponding legal framework help achieve this promotion. ...more
On November 6, 2025, Amgen filed its eighth and ninth BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-17277 (D.N.J.) against Alvotech and Dr. Reddy’s AVT03 and Case No....more
On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzumab biosimilar to receive...more
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES) to demonstrate biosimilarity in an abbreviated biologics license application (aBLA). ...more
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc., Biocon...more
On September 26, 2025, Amneal / Kashiv announced the submission to the FDA of an aBLA for ADL-018, a proposed biosimilar of Genentech’s Xolair® (omalizumab)....more
Decades of stifled research into the therapeutic effects of psychedelics followed the “War on Drugs” that was codified in the Controlled Substances Act of 1970. However, over the past two decades, there has been renewed...more
In an unprecedented move, starting in July 2025, the U.S. Food and Drug Administration (FDA) released communications that have previously remained unpublished and confidential to the public. Specifically, Complete Response...more
Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act. Novartis Pharms. Corp. v....more
Nature of the Case and Issue(s) Presented: Ozobax is indicated for treatment of spasticity resulting from multiple sclerosis, and particularly flexor spasms and concomitant pain, clonus, and muscular rigidity. While the use...more
On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna)...more