Topic
FDA Approval
200 published works
The Securities Law Blog
SEC Charges Kiromic BioPharma and Two Former C-Suite Executives with Misleading Investors about Status of FDA Reviews
The Securities and Exchange Commission today filed settled charges against Houston-based biotherapeutics company Kiromic BioPharma, Inc., its former CEO, Maurizio Chiriva-Internati, and its former chief financial officer, Tony Tontat, for…
Biosimilars Law Bulletin
Defining an Orange Book ‘Drug’
By An Nguyen
The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva…
Big Molecule Watch
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…
Health Law Prof Blog
Gatekeeping Drugs
David A. Simon (Northeastern University), Gatekeeping Drugs (Northeastern U. Sch. of L. Rsch. Paper) (forthcoming):How much evidence should pharmaceutical manufacturers be required to provide before they can market new drugs?…
Intellectual Property Law Blog
Federal Circuit Provides Insight on Induced Infringement Claims in Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.
The case of Amarin Pharma, Inc. and its affiliates versus Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC presents a fascinating intersection of patent law, FDA regulatory strategy, and pharmaceutical…
Healthcare Law Blog
Supreme Court Unanimously Preserves Access to Mifepristone
By Elizabeth Nevins, Calla Simeone, Danielle Vrabie, Amanda Zablocki
In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication…
Regulatory Oversight
Federal and State Approaches to Therapeutic Cannabis
By Agustin Rodriguez, Zie Alere
Across states, lawmakers often embrace "medical" marijuana as a precursor to establishing a "recreational" marijuana market. Although marijuana remains illegal at the federal level — and would remain illegal even…
Big Molecule Watch
FDA Approves Boehringer Ingelheim’s CYLTEZO® Biosimilar to Humira for Multiple Chronic Inflammatory Diseases
Earlier this month, FDA approved Boehringer Ingelheim’s high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in 2017 and later…
Health Industry Washington Watch
SCOTUS Arguments on Mifepristone Cases Focus on Standing and Remedy
By Scot Hasselman, Lesley Reynolds, Whitney Petrie, Matthew Loughran
The U.S. Supreme Court heard arguments yesterday in the two consolidated cases challenging the U.S. Food and Drug Administration (FDA) approval of mifepristone. Throughout the questioning, the Justices focused on…
Drug & Device Law
Medical Cannabis in Pennsylvania – Since It’s Legal, It’s Reimbursable, FDA Regulatory Status Notwithstanding
By Bexis
We generally keep our distance from medical cannabis/marijuana. We’re not one of those blogs. But if legal holdings of interest to us happens to involve cannabis, we will comment. Thus,…