Innovation in Compliance: Unpacking Healthcare Compliance with Maria Villanueva
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 190: Healthcare Tech and Human Resources with Shannon Frazier, HR Executive Director at Lenovo
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 3 – The Specifics of Managing Obesity
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 153: William Kenley, CEO, and Juana Slade, Chief Diversity Officer and Director of Language Services, AnMed Health
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 2- Revolutionizing Healthcare: Personalized Medicine
Private Equity VS Real Estate Transactions | #6 What’s the Best Order to Sell?
Episode 152: Matt Littlejohn, CEO, MUSC Health Midlands
Private Equity VS Real Estate Transactions | #4 Optimizing Total Asset Value
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 151: Erin Ford, EVP & COO, and David Stefanich, Board Chair, SCBIO
Private Equity VS Real Estate Transactions | #3 Real Estate Valuations Explained
AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
Podcast - Counsel That Cares - The Value of Value-Based Cancer Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Podcast - The Latest on Antitrust and Non-Compete Agreements in Healthcare
Strategies to Manage Costs of Medical Care in a PA Workers’ Compensation Claim
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 149: Patrick Goodwill, CEO, Magnetic Insight
Podcast - Noteworthy Value-Based Care Mergers and Acquisitions Transactions
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 146: Ann Lewis, CEO, CareSouth
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....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....more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
The Fenwick life sciences team recently returned from the 2024 JP Morgan Healthcare conference. As we reflect back on the week, there were several key themes and trends that we expect will continue to resonate and evolve over...more
On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more
Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more
Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter...more
Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more
Top Five Healthcare Antitrust Trends to Watch in 2017 - Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...more
The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more
Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more
When is a combination of two separate treatments for a particular disease obvious-to-try, such that it is rendered obvious for the purposes of patentability? The Supreme Court answered this question in KSR Int'l Co. v....more