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Manufacturers Pharmaceutical Industry

Hogan Lovells

Life Sciences Procurement Update: FY2025 NDAA Would Changes to Rules of Origin for Drugs

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In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more

Morgan Lewis

China Boosts Regulatory Framework for Local Pharmaceutical Manufacturing

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In recent years, China has introduced significant changes to its Drug Administration Law and corresponding legislation, including the nationwide Market Authorization Holder (MAH) system. These reforms aim to boost foreign...more

Hogan Lovells

FDA promotes pre-approval for changes to devices, LDTs via PCCPs

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The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for...more

McDermott Will & Emery

This Week in 340B: August 20 – 26, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Bennett Jones LLP

Differences in Consumer Protection Legislation Continue to Deter National Consumer Protection Based Class Actions

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The Supreme Court of British Columbia’s recent December 2023 decision in MacKinnon v Pfizer Canada Inc. (MacKinnon) illustrates that certifying a national class action against product manufacturers based on breaches of...more

Searcy Denney Scarola Barnhart & Shipley

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Patterson Belknap Webb & Tyler LLP

Jury Rejects Tevra's Embattled Market Definition in Antitrust Suit

On August 1, 2024, following five years of litigation, Tevra’s antitrust suit against Bayer Healthcare LLC came to an end. Tevra, a manufacturer of generic version topical flea and tick medications, alleged that Bayer engaged...more

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

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As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Manatt, Phelps & Phillips, LLP

340B Hospitals Sue HRSA for Authorizing Audits of 340B Records

On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more

A&O Shearman

Health Care Company Secures Antitrust Victory With Jury Verdict In Its Favor

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On August 1, 2024, a unanimous jury in the United States District Court for the Northern District of California found plaintiff, a veterinary drug manufacturer, failed to allege a relevant antitrust market under Sherman Act,...more

McDermott Will & Emery

This Week in 340B: August 2 - 7, 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...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

Gardner Law

FDA Drafts Guidance on Correcting “Misinformation”

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The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more

Manatt, Phelps & Phillips, LLP

OIG Concludes Gene Therapy Manufacturers Could Violate Law By Providing Fertility Support to Patient

On July 22 and July 23, Health and Human Services (HHS) Office of Inspector General (OIG) published two advisory opinions for proposals by pharmaceutical manufacturers to provide fertility support to patients receiving their...more

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

Hogan Lovells

Q2/2024 Life Science Law Update – Key developments for pharma & device companies in EU

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The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition, and privacy....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

Cozen O'Connor

Democratic AGs File Amicus Brief Supporting Drug Pricing Transparency Law

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A group of 21 Democratic AGs filed an amicus brief with the U.S. Court of Appeals for the Ninth Circuit supporting Oregon in its defense of H.B. 4005, which requires pharmaceutical manufacturers to report certain information...more

Hogan Lovells

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

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The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more

McDermott Will & Emery

Key Takeaways | Pharma and MedTech Manufacturing and Contract Development

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During the session, the panelists discussed investment strategies in the Contract Development and Manufacturing Organization (CDMO) space, emphasizing factors like supply and demand dynamics, quality control, and the impact...more

Faegre Drinker Biddle & Reath LLP

Worried About Misinformation? FDA Is Too. Here’s What You Should Know.

On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

McDermott Will & Emery

This Week in 340B: July 2 – 8, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Epstein Becker & Green

FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans

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The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more

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