News & Analysis as of

Supply Shortages

Vinson & Elkins LLP

California Enacts Expansive New Refinery Controls

Vinson & Elkins LLP on

On October 14, 2024, California Governor Gavin Newsom signed into effect ABX2-1, which was developed and passed in a special legislative session. The aggressive new law — ostensibly designed to prevent the sort of supply...more

McDermott Will & Emery

Tirzepatide Shortage Resolved

McDermott Will & Emery on

On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

Dechert LLP

Life Sciences: What's new in Europe?

Dechert LLP on

The Servier case: The game isn’t over yet - The European Court of Justice recently issued seven judgments in the landmark "Servier" case, confirming the anticompetitive nature of "pay-for-delay" agreements between...more

Dechert LLP

Health is priceless; supply shortages come at a high price, as determined by the sanctions imposed by the French Health Agency

Dechert LLP on

As is often the case, France has been a pioneer in implementing a mandatory safety stock, especially for essential drugs. Since 2021, pharma companies must hold at least a 2-month safety stock to meet the needs of patients on...more

Foley & Lardner LLP

GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List

Foley & Lardner LLP on

On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared...more

DLA Piper

The Chips Are Down – A Look Into Semiconductors and the Automotive Industry

DLA Piper on

Industries around the world have been hugely affected by global events over the past several years. Wars, famine and water shortages, political unrest and pandemics have all contributed to persistent supply constraints for...more

Knobbe Martens

Understanding the Dangers of Counterfeit Drugs Through the Lens of Fake Ozempic

Knobbe Martens on

The June 2024 issue of Vanity Fair included the provocative headline: “Why Counterfeit Ozempic Is a Global-Growth Industry." Novo Nordisk’s patented drug Ozempic® (semaglutide injection) was first approved by the FDA in 2017...more

Foley & Lardner LLP

Foley Automotive Update - June 2024 - 2

Foley & Lardner LLP on

This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Cox Automotive predicts U.S. new light-vehicle sales in the first half...more

Foley & Lardner LLP

Foley Automotive Update - June 2024

Foley & Lardner LLP on

Analysis by Julie Dautermann, Competitive Intelligence Analyst This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley &...more

Axinn, Veltrop & Harkrider LLP

Can an Enhanced India-U.S. Partnership Reduce Drug Supply Chain Issues?

In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more

McDermott+

Breaking Down Federal Policies to Address Drug Shortages

McDermott+ on

In the wake of persistent drug shortages that compromise patient care and safety, the Biden administration and Congress have proposed policies to strengthen the pharmaceutical supply chain. Using authorities under both...more

Foley & Lardner LLP

Foley Automotive Update - May 2024 - 3

Foley & Lardner LLP on

This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley & Lardner partner Ann Marie Uetz offers insight on the dynamics...more

King & Spalding

CMS Issues IPPS and LTCH Proposed Rule for FY 2025

King & Spalding on

On April 10, 2024, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for Fiscal Year (FY) 2025 (the Proposed Rule). In...more

McDermott+

HHS Releases New Proposal to Address Drug Shortages

McDermott+ on

A few weeks ago, Regs & Eggs focused on nine health-related issues that were not included in the Fiscal Year (FY) 2025 President’s Budget. Another policy absent from the budget was the Administration’s plan to address drug...more

Foley & Lardner LLP

Foley Automotive Update - April 2024

Foley & Lardner LLP on

This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley & Lardner LLP partner Nicholas Ellis is quoted in the Supply...more

Foley & Lardner LLP

Introduction: What is Supply Chain Management?

Foley & Lardner LLP on

Share on Twitter Print Share by Email Share Back to top In recent years, viral videos featuring a surprising topic have racked up millions of views on social media. Not videos of a celebrity doing something outrageous, a...more

Foley Hoag LLP - White Collar Law &...

Congressional Investigations: A Review of Investigations Likely to Continue in 2024 and into the 119th Congress

This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

Foley Hoag LLP

Federal Regulators Examine the Role of Drug Supply Middlemen on Drug Shortages

Foley Hoag LLP on

The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more

StoneTurn

Risk Awareness and Mitigation in Disaster Recovery: During a Catastrophe

StoneTurn on

In 2022, the United States experienced 18 separate weather and climate disasters costing at least one billion dollars according to NOAA. In 2023, that number rose to 28 separate billion dollar weather events. The frequency...more

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more

Axinn, Veltrop & Harkrider LLP

Biden Administration Promotes Domestic Pharmaceutical Production to Reduce Drug Shortages

I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more

Axinn, Veltrop & Harkrider LLP

Thankful for Pharmaceuticals . . . Especially When There are Shortages

5 When our children were young, we started a tradition at Thanksgiving of going around the table and having each of us (around 20 with extended family) saying what we were thankful for. Of course, you hear a lot of being...more

Foley & Lardner LLP

Foley Automotive Update - November 2023

Foley & Lardner LLP on

This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley & Lardner partner Vanessa Miller and retired partner John...more

202 Results
 / 
View per page
Page: of 9

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide