News & Analysis as of

Medicare Abbreviated New Drug Application (ANDA)

Alston & Bird

Health Care Week in Review: HHS Announced Updates on Response to IV Fluid Shortage and 233 Members Call on House Leadership to...

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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

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

WilmerHale on

Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Akin Gump Strauss Hauer & Feld LLP

Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations

Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more

Alston & Bird

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

Alston & Bird on

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: Biden Administration Released FY2025 Budget; Bill Introduced to Make Telehealth Permanent

Alston & Bird on

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

Court Grants Summary Judgment Ending AstraZeneca’s Lawsuit Challenging the IRA

Goodwin on

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program...more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Alston & Bird

Health Care Week in Review: CMMI Model and IRA Part B Drug List

Alston & Bird on

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: CMMI Announces Three New Models, President Biden Issues Executive Order

Alston & Bird on

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

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Foley & Lardner LLP

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Foley & Lardner LLP on

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation

As it has frequently in the past decade, the Federal Trade Commission on Thursday released a Report on the frequency of reverse payment settlement agreements in ANDA litigation between generic and branded drug makers,...more

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