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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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Walgreens Deal Leads Parade of Take-Private Transactions

Intelligize Blog

The Centers for Disease Control and Prevention is reporting sharp year-over-year increases in its estimates of indicators such as flu-related hospitalizations for the 2024-2025 cycle. billion; and Aerospace manufacturer Triumph Group Inc. Flu season has hit the United States with a vengeance this year. a price of approximately $6.25

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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.

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The Clean Energy Investment Tax Credit (ITC): Direct Pay Claimants’ Race Against Time

ClimateChange-ClimateLaw

In 2025, that reduction in base credit will increase to 15 percent and in 2026, the base credit amount for direct pay claimants that cannot achieve the domestic content requirements will be reduced by 100 percent. In short, that the IRA could have been better drafted does not mean that nontaxpayers shouldn’t take full advantage.

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A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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Customs and Trade News Weekly Snapshot

Customs & International Trade Law

CBP published updated draft Cargo Release CATAIR, draft Global Business Identifier Enrollment Create-Update, GBI Enrollment GO Status Notification, and GBI Condition Codes documents to its website. Fruit juice manufacturing company and its former president plead guilty to food safety crimes. Sign up for ourweekly snapshot!

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Guest Blog: Big Announcements About New York Offshore Wind Development Mark Small (but Important) Steps Toward Meeting 2035 Target

ClimateChange-ClimateLaw

The draft of New York’s Clean Energy Standard Biennial Review was published July 1 by New York State Department of Public Service (NYS DPS) and New York State Energy Research and Development (NYSERDA). The 2024 offshore solicitation process is currently underway and awards will be announced Q1 of 2025.