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Jenner & Block
Anti-DEI litigants have zeroed in on the healthcare industry in their growing number of legal challenges to diversity, equity, and inclusion (DEI) initiatives.
AlixPartners
Failure to adequately respond to the burgeoning use of GLP-1 drugs like Ozempic and Wegovy could cost a $5 billion grocer as much as $350 million in revenue in a single year.
Ankura Consulting Group LLC
Over the past several years, legislators across the country have focused their attention on Pharmacy Benefit Managers (PBMs) due to concerns expressed over a variety of industry practices.
Mintz
On March 1, 2024, New Mexico joined a growing number of states in enacting legislation that increases oversight of certain health care transactions. Senate Bill 15 (S.B. 15)...
Hall Benefits Law
The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services has announced its first settlement of a HIPAA case involving a phishing cyberattack.
Goodwin Procter LLP
On March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen's XGEVA and PROLIA.
Foley Hoag LLP
In the USA, prescription drug advertising is primarily regulated by the US Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act)...
Crowell & Moring LLP
On February 16, 2024, the U.S. Department of Health and Human Services ("HHS") published a final rule ("Final Rule") in the Federal Register modifying regulations at 42 C.F.R. part 2 ("Part 2")...
Sheppard Mullin Richter & Hampton
On February 16, the U. S. District Court for the District of Oregon struck down the state's drug price transparency law—The Prescription Drug Price Transparency Act (the "Act"...
Hyman, Phelps, & McNamara
Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts...
Hyman, Phelps, & McNamara
In 2009—15 years ago— the National Organization for Rare Disorders (NORD) announced the first U.S. recognition of Rare Disease Day.
Venable LLP
On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry.
Fenwick
The first stage of First Lady Dr. Jill Biden's White House Initiative on Women's Health Research kicked off on March 6, 2024, when the Department of Health and Human Services ARPA-H Sprint...
Mintz
In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA's long-awaited proposed rules...
Goodwin Procter LLP
This annual recap highlights Goodwin's continued determination and agility as a full-service, integrated global practice. Committed to being a global destination life cycle law firm...
Hyman, Phelps, & McNamara
The trio of CDER, CBER, and CDRH released a new draft guidance titled "Use of Data Monitoring Committees in Clinical Trials" that revises the 2006 guidance...
Goodwin Procter LLP
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson ("J&J") regarding Bmab 1200, Biocon's proposed biosimilar to STELARA.
Goodwin Procter LLP
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon's proposed biosimilar to EYLEA.
Sheppard Mullin Richter & Hampton
On March 5, 2024, the Federal Trade Commission ("the FTC") hosted a public workshop titled "Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care"...
Hyman, Phelps, & McNamara
The American Conference Institute ("ACI") will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes.
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