We expect the IRA’s drug pricing controls and Medicare Part D redesign may have an adverse impact on our full-year sales, particularly for our products that are more substantially reliant on Medicare reimbursement. We anticipate the IRA Medicare Part D redesign will have a modest net unfavorable impact to our 2025 revenue, ranging from approximately $50.0 million to $100.0 million, concentrated in our SKYCLARYS and MS portfolio product revenue, approximately a third of which could be associated with SKYCLARYS.
All entries for: Biologic
October 30, 2025
Genentech
Layoffs
South San Francisco, CA
10,000+ employees
Genentech is laying off employees at its South San Francisco headquarters. According to a Worker Adjustment and Retraining Notification (WARN) Act notice, 118 staffers will lose their jobs effective Nov. 28.
Disease Area: Cardiology, Hematology, Immune Diseases, Neurological Diseases, Oncology
Drug Type: Biologic, Small Molecule
October 29, 2025
United Therapeutics
Neutral Outlook
Silver Spring, MD
1,001-5,000 employees
Our ability to maintain attractive pricing and reimbursement levels for our products, in light of increasing competition, including from generic products, and pressure from government and other payers to decrease the costs associated with healthcare, including the potential impact of the Inflation Reduction Act of 2022 (IRA) on our business and President Trump’s most favored nation pricing initiative.
Disease Area: Cardiology, Rare Diseases, Respiratory Diseases
Drug Type: Biologic, Small Molecule
October 28, 2025
Neurocrine Biosciences Inc
Negative Outlook
San Diego, CA
1,000-5,000 employees
Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the Inflation Reduction Act of 2022 (IRA), could adversely affect our business.
Disease Area: Endocrinology, Multiple, Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
October 28, 2025
Regeneron Pharmaceuticals
Neutral Outlook
Tarrytown, NY
10,000+ employees
Notably, in 2022 the U.S. Congress passed the Inflation Reduction Act (“IRA”), which includes, among other items, provisions regarding the following: Implementation of a Medicare Drug Price Negotiation Program (the “Medicare Drug Price Negotiation Program”). The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D. Starting in 2023 and 2026, the government is authorized to select Part D and Part B drugs, respectively, for inclusion in the Medicare Drug Price Negotiation Program, with established prices to go into effect for selected Part D drugs in 2026 and for selected Part B drugs in 2028, in each case absent certain disqualifying events, Medicare Inflation Based Rebates. The IRA includes measures requiring manufacturers to pay rebates where increases to the average sales price or average manufacturer price of drugs covered under Medicare Parts B and D, respectively, exceed the rate of inflation, Medicare Part D Program Redesign. The IRA implements changes to the Medicare Part D benefits to limit patient out-of-pocket drug costs and shift program liabilities from patients to other stakeholders, including health plans, manufacturers, and the government.
Disease Area: Multiple
Drug Type: Biologic, Small Molecule
October 28, 2025
Incyte Corp
Neutral Outlook
Wilmington, DE
1,001-5,000 employees
Further, in August 2022, the Inflation Reduction Act of 2022 was enacted, which includes provisions allowing the federal government to negotiate prices for certain high-expenditure single source Medicare drugs, to impose penalties and to implement a potential excise tax for manufacturers that fail to comply with the negotiation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and to impose rebate liability on manufacturers that take price increases that exceed inflation. The new law also reduced the out-of-pocket prescription drug costs for Medicare Part D beneficiaries, and to help pay for this change in benefit design, the law imposes a new discount program starting in 2025, in which manufacturers pay specified discounts on Medicare Part D utilization of their drugs as a condition of selling such drugs in the Medicare Part D program. The Inflation Reduction Act includes certain exemptions for small biotech drug manufacturers, including Incyte.
Disease Area: Dermatology, Immune Diseases, Multiple, Oncology
Drug Type: Biologic, Small Molecule
October 28, 2025
Regeneron Pharmaceuticals
Neutral Outlook
Tarrytown, NY
10,000+ employees
Notably, in 2022 the U.S. Congress passed the Inflation Reduction Act (“IRA”), which includes, among other items, provisions regarding the following:
•Implementation of a Medicare Drug Price Negotiation Program (the “Medicare Drug Price Negotiation Program”). The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D. Starting in 2023 and 2026, the government is authorized to select Part D and Part B drugs, respectively, for inclusion in the Medicare Drug Price Negotiation Program, with established prices to go into effect for selected Part D drugs in 2026 and for selected Part B drugs in 2028, in each case absent certain disqualifying events.
•Medicare Inflation Based Rebates. The IRA includes measures requiring manufacturers to pay rebates where increases to the average sales price or average manufacturer price of drugs covered under Medicare Parts B and D, respectively, exceed the rate of inflation.
•Medicare Part D Program Redesign. The IRA implements changes to the Medicare Part D benefits to limit patient out-of-pocket drug costs and shift program liabilities from patients to other stakeholders, including health plans, manufacturers, and the government.
Disease Area: Hematology, Immune Diseases, Multiple, Neurological Diseases, Oncology, Rare Diseases
Drug Type: Biologic, Small Molecule
October 23, 2025
Alector
Layoffs
South San Francisco, CA
201-500 employees
GSK-partnered Alector will pull the plug on its investigational antibody latozinemab, which it had been developing for a genetic form of frontotemporal dementia, and cut 49% of its workforce. The layoffs will affect about 75 employees.
Disease Area: Immune Diseases, Multiple, Neurological Diseases, Oncology
Drug Type: Biologic
October 22, 2025
Galapagos
Discontinued Research, Layoffs
Cambridge, MA
1,001-5,000 employees
Galapagos intends to shutter its cell therapy business, which would affect about 365 employees across Europe, the United States and China and include site closures in New Jersey and Pennsylvania.
Disease Area: Chronic Disease, Immune Diseases, Multiple
Drug Type: Biologic, Small Molecule
October 16, 2025
Novo Nordisk
Layoffs
Bagsværd
10,000+ employees
As part of its restructuring that includes cutting about 9,000 employees globally, Novo Nordisk is laying off U.S. employees this week and continuing into next week. Reuters noted that based on an email it received, affected departments include HR, clinical development, rare diseases, medical and regulatory, legal, ethics and compliance, marketing and sales, finance and public affairs.
Disease Area: Chronic Disease, Metabolic Diseases, Neurological Diseases, Rare Diseases
Drug Type: Biologic, Small Molecule