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Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and...more
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
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
In litigation news . . . For the third consecutive month, Tesla finds itself involved in a new patent infringement lawsuit, this latest time as a defendant in an action filed by Graphite Charging Company LLC on August 4,...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Foley & Lardner will host a half-day Automotive Forum on Wednesday,...more
As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more
ACI’s 6th Annual Advanced Summit on Food Law – Regulation, Compliance, and Litigation is returning to Chicago this July! As the pandemic turns into an endemic, you need to revise your playbook to tackle the food industry’s...more
Outlook for This Week in the Nation’s Capital - Congress. The House is in a committee work period, and the Senate is in session this week. Senate Majority Leader Chuck Schumer (D-N.Y.) is planning a procedural vote this week...more
With significant fanfare, on 8 February 2022, the European Commission (the Commission) published its proposal for an EU Chips Act (the Act). The Commission President, Ursula von der Leyen, proclaimed the proposed Act a “game...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - The Wall Street Journal quotes Foley & Lardner partner John Trentacosta in...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - U.S. new light-vehicle sales in August are forecast to reach a SAAR of...more
Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Production downtime during July and August has been scheduled for five GM...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - U.S. new light vehicle sales in June reached a SAAR of 15.4 million units,...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - AlixPartners forecasts U.S. new light-vehicle sales of 16.4 million units...more
Industry-Specific Primer – Semiconductor Manufacturing And Advanced Packaging - On June 8, 2021, the Biden Administration issued the reports mandated by the Executive Order on America’s Supply Chains (the “America’s Supply...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Fitch Ratings and AutoForecast Solutions estimate a global production...more
As criminal cyberattacks and ransomware attacks on critical infrastructure increase, companies may experience significant business disruptions. Ransomware and cyberattacks may prevent companies from fulfilling contractual...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - In a revised forecast, consultancy AlixPartners predicts the global auto...more
The U.S. Senate has kicked off the complicated process of coordinating and passing multi-committee legislation designed to bolster U.S. technological capabilities, expand the U.S. political, diplomatic, and economic toolkit...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - LMC Automotive increased its 2021 U.S. light vehicle sales forecast to 17...more
This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Preliminary estimates for U.S. new light vehicle sales in April predict a...more