Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more
On June 1, 2023, the United States Supreme Court issued an important decision addressing the intent element of the False Claims Act (“FCA”) in United States ex rel. Tracy Schutte v. SuperValu Inc. and United States ex rel....more
On Tuesday, April 18, 2023, the Supreme Court heard argument in the consolidated cases of United States ex rel. Schutte v. SuperValu, Inc., and United States ex rel. Proctor v. Safeway, Inc., to consider whether subjective...more
On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more
McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more
Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more
The U.S. Senate on Aug. 7, 2022, passed the Inflation Reduction Act of 2022 (IRA). This comprehensive legislation is the result of many months of negotiations among Democrats to advance some of President Joe Biden's highest...more
While, historically, government enforcement of the Robinson-Patman Act has been virtually non-existent, the Federal Trade Commission (FTC) recently announced its intention to dust-off the oft-forgotten Act to encourage...more
On June 21, 2022, Novartis Pharmaceuticals Corp.'s patent for a method of treating multiple sclerosis with fingolimod (Gilenya®) was held invalid for lack of written description under 35 U.S.C. § 112(a). Gilenya® was...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers. This new system will also create a new form of pharmaceutical patent litigation in...more
A federal court in Indiana dismissed the disability discrimination and retaliation claims of a DOT-regulated driver who failed a random drug test due to prescription opioid use, holding that he did not sufficiently adhere to...more
On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit issued an opinion in Impax Laboratories, Inc v. Federal Trade Commission, affirming the Federal Trade Commission's (FTC) unanimous decision that Endo...more
Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more
In the recently-decided Rutledge v. Pharmaceutical Care Management Association (“PCMA”), the Supreme Court found 8–0 (Justice Barrett did not take part) that ERISA did not preempt an Arkansas state law that established...more
Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more
So, who doesn’t daydream a little about money? Maybe even big money. Just imagine a scenario where, if you could put up $3,000, you could keep $13,000, or if you forked over $30,000, and walked away with $130,000? So how...more
The concept of dominance plays a pivotal role in European antitrust law. The creation or strengthening of a dominant position is an example of the “significant impediment to effective competition” that grounds the prohibition...more
The Department of Justice’s (“DOJ”) most recent settlement with Indivior Solutions, Inc., Indivior Inc., and Indivior plc (together, “Indivior”) demonstrates not only that the DOJ is continuing its pursuit of claims and...more