AUSTEDO and AUSTEDO XR, marketed by Teva Pharmaceuticals Industries, have been selected for the Medicare drug negotiation program in 2025 (for initial price applicability year 2027). If the negotiation program results in a decrease in the price of AUSTEDO or AUSTEDO XR, it may result in increased competitive pressure on INGREZZA. We were notified in January 2025 that INGREZZA qualifies for the small biotech exception, which provides an exemption from selection until 2027 (for initial price applicability year 2029, pursuant to which negotiated pricing would go into effect, if selected). If negotiated for initial price applicability year 2029, we expect that the negotiated price for INGREZZA would be constrained by the “short monopoly” price ceiling and temporary price floor for small biotech drugs.
All entries for: Endocrinology
Neurocrine Biosciences Inc
Neutral Outlook
San Diego, CA
1,001-5,000 employees
Conduit Pharmaceuticals
Negative Outlook
Naples, FL
1-50 employees
On August 16, 2022, President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA. Among other things, the IRA has multiple provisions that can impact the prices of drug products that are both sold into the Medicare program and throughout the United States. Beginning in 2023, a manufacturer of drugs covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price increases faster than the rate of inflation. This calculation is made on a drug product by drug product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, starting for payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.
Vertex Pharmaceuticals
Layoffs
Providence, RI
5,001-10,000 employees
Just months after shelving its cell therapy–device combo for type 1 diabetes, Vertex Pharmaceuticals is parting ways with 140 employees, according to a Worker Adjustment and Retraining Notification letter dated June 6. The layoffs will heavily focus on the company’s Rhode Island operations, where 125 employees will be affected, as per the state’s WARN posting. There, Vertex is consolidating its three Providence sites, which currently form somewhat of an “integrated campus” in the city, into just one location, as per the WARN letter. “We presently expect this action to be permanent,” wrote Camilo Cobos, the biotech’s vice president of human resources.
AbCellera
Negative Outlook
Vancouver, BC
501-1,000 employees
In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single-source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Various industry stakeholders, including pharmaceutical companies, the U.S. Chamber of Commerce, the National Infusion Center Association, the Global Colon Cancer Association, and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. The impact of these judicial challenges, legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the government on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.
Spruce Biosciences
South San Francisco, CA
1-50 employees
For example, the Inflation Reduction Act (“IRA”) passed by the U.S. Congress authorizes the Secretary of the Department of Health and Human Services (“HHS”) to negotiate prices directly with participating manufacturers for selected medicines covered by Medicare even if these medicines are protected by an existing patent. For small molecule medicines, the process begins seven years after initial approval by the FDA. While we do not believe that the IRA or its effects will impact our ability to obtain patents in the near future, we cannot be certain that it will not affect our patent strategy in the long term.
Rhythm Pharmaceuticals
Neutral Outlook
Boston, MA
201-500 employees
While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.
AbCellera Biologics
Negative Outlook
British Columbia
501-1,000 employees
The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved. Complying with any new legislation and regulatory changes could be time-intensive and expensive, resulting in a material adverse effect on our business
Spruce Biosciences
Layoffs
South San Francisco, CA
1-50 employees
A little over a year after cutting 21% of its workforce, Spruce Biosciences has disclosed it’s axing 55% of its employees, according to an April 25 SEC filing. The San Francisco–based late-stage biopharma had 21 employees as of Dec. 31, 2024, according to an April 15 SEC filing, meaning that the layoffs could leave the business with around 10 employees.
Organon
Layoffs
Jersey City, NJ
1,001-5,000 employees
As part of its efforts to optimize internal operations, Organon will lay off 93 employees at its headquarters in Jersey City, New Jersey, according to a Worker Adjustment and Retraining Notification notice. The cuts will be effective starting April 30 and will wrap up May 31.