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Hissey, Mulderig & Friend, PLLC

Ozempic, Other Diabetes-Weight Loss Drugs Linked to 162 Deaths, According to FDA Data

Ozempic and other diabetes-weight loss drugs have been linked to at least 162 deaths and 10,000 cases involving “serious” injuries since 2018, according to data from the U.S. Food and Drug Administration (FDA)....more

White & Case LLP

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

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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

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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

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

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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

King & Spalding

President Biden Orders Comprehensive Supply Chain Review

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Articulates Administration Policy And Reaffirms Need For “Strong, Resilient Supply Chains” For “Critical And Essential Goods And Materials” - On February 24, 2021, President Joseph R. Biden Jr. signed an Executive Order on...more

Butler Snow LLP

HHS Declares Liability Immunity for Certain COVID-19 “Countermeasures”; Response Act Expands Protections for Mask Makers

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Earlier this week, we discussed current trends and future implications of COVID-19 on businesses operating in the products arena, noting the most direct impact so far on the pharmaceutical and medical device spaces....more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

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In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Mintz - Intellectual Property Viewpoints

HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?

On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more

Patrick Malone & Associates P.C. | DC Injury...

FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more

Faegre Drinker Biddle & Reath LLP

Top Five Drug and Device Developments of 2018

It’s that time of year again—the end of one and beginning of another—when we pause, reflect and look forward to the year ahead. In this retrospective, we consider the past year’s legal developments in the drug and medical...more

Cozen O'Connor

The State AG Report Weekly Update November 2018 #4

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Breaking News- Wyoming Governor-Elect Announces Appointment of Attorney General- Bridget Hill has been appointed to serve as the Wyoming AG by Governor-elect Mark Gordon (R). ...more

Jones Day

Antitrust Alert: New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities

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Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar companies that relate to the...more

Arnall Golden Gregory LLP

It Starts and Stops at the Top: FDA Issues Warning Letters for Lack of Corporate Oversight

The Food and Drug Administration issued two Warning Letters recently to pharmaceutical manufacturers where lack of corporate oversight was an issue. These Warning Letters reaffirm that senior management cannot delegate or...more

Benesch

Benesch’s 2nd Annual 3D Printing Seminar (A Summary Repeat)

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Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more

Benesch

3D Printing and the Renaissance of Local Economies

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The rise of 3D printing holds tremendous potential to impact the economy from the local to the national level. Although it is still an estimated five to 10 years away from mainstream consumer adoption, we are already seeing...more

BakerHostetler

FDA Allowing Additional Comment Period for Draft Social Media Guidances

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The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

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