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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Sheppard Mullin Richter & Hampton LLP

Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?

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On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more

Oberheiden P.C.

Ozempic Lawsuit Update: New Study Links Semaglutides to Increased Risk of Vision Loss

Oberheiden P.C. on

More plaintiffs are continuing to join the diabetes drug Ozempic lawsuits against Novo Nordisk; and, until a couple of weeks ago, some court watchers were estimating that the total number of federal lawsuits involving Ozempic...more

McDermott Will & Emery

Weight Loss Drug Shortages Will End Soon

McDermott Will & Emery on

On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list. In particular, FDA updated the availability of...more

Goodwin

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

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On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more

Sheppard Mullin Richter & Hampton LLP

China Proposed New Anti-Monopoly Guidelines for the Pharmaceutical Sector

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On August 9, 2024, China’s State Administration for Market Regulation (SAMR) released a draft of the Anti-Monopoly Guidelines for the Pharmaceutical Sector (hereinafter referred to as the “AMGP”) for public comment. The AMGP...more

Epstein Becker & Green

FTC Releases Controversial Interim Staff Report on PBMs’ Purported Impact on Drug Prices

Epstein Becker & Green on

At an Open Commission Meeting on August 1, 2024, the Federal Trade Commission (FTC) presented a report prepared by its staff entitled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main...more

White & Case LLP

Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024

White & Case LLP on

It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more

Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

Hogan Lovells on

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

Manatt, Phelps & Phillips, LLP

Media Reports FTC Poised to Sue PBMs

Manatt, Phelps & Phillips, LLP on

In the wake of the FTC’s July 9 vote to release an interim staff report on PBMs, several media outlets are reporting that the Commission is poised to sue large PBMs. The timing and nature of the litigation is unspecified,...more

Foley & Lardner LLP

The Rise of GenAI in Personalized Medicine and Beyond

Foley & Lardner LLP on

GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more

Ballard Spahr LLP

FinCEN Issues Supplemental Advisory on Fentanyl Distribution and Growing Role of Transnational Criminal Organizations

Ballard Spahr LLP on

On June 20, 2024, the Financial Crimes Enforcement Network (“FinCEN”) issued a supplemental advisory to alert U.S. financial institutions about emerging trends in the illicit fentanyl supply chain. The supplemental advisory...more

Manatt, Phelps & Phillips, LLP

Court Rules in Favor of Manufacturers in 340B Drug Shipment Case

Manatt, Phelps & Phillips, LLP on

On May 21, the U.S. Court of Appeals for the District of Columbia Circuit upheld the right of pharmaceutical manufacturers to place at least some restrictions on the shipment of 340B drugs to contract pharmacies of 340B...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - April 2024

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This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more

Goodwin

FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU

Goodwin on

​​​​​​​On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - March 2024

WilmerHale on

Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Alston & Bird

Health Care Week in Review: CMS Issues Rules on FY 2025 Payment Rates; Medicaid Enrollment; and Short-Term, Limited Duration...

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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

Goodwin

Biden Administration Proposes Biosimilar Substitution Without Interchangeability

Goodwin on

​​​​​​​The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. ...more

Polsinelli

Regeneron v Novartis and Vetter: Walker Process Client Update

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In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on

Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

Alston & Bird

Health Care Week In Review: Biden Administration Released FY2025 Budget; Bill Introduced to Make Telehealth Permanent

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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

ArentFox Schiff

Health Care Providers Navigate Fallout of Major Cyberattack on Change Healthcare

ArentFox Schiff on

Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more

Alston & Bird

Health Care Week in Review: House Passes Minibus, HHS Releases Public Inquiry on Private Equity in Health Care

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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

Alston & Bird

Health Care Week in Review: Congress Passed a New Continuing Resolution for FY 2024 to Avert a Government Shutdown; Biden...

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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

Hissey, Mulderig & Friend, PLLC

Mounjaro, Ozempic Lawsuits Allege Weight Loss, Diabetes Drugs Linked to Serious Gastrointestinal Problems

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Lawsuits filed against the manufacturers of Ozempic, Mounjaro, and other weight control and diabetes drugs have alleged that these medications can cause serious gastrointestinal side effects, including gastroparesis, stomach...more

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