Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. This provision applies to drug products that have been approved for at least 9 years and biologics that have been licensed for 13 years, but it does not apply to drugs and biologics that have been approved for a single rare disease or condition. Nonetheless, since CMS may establish a maximum price for these products in price negotiations, we would have been fully at risk of government action if our products were the subject of Medicare price negotiations. Moreover, given the risk that could be the case, these provisions of the IRA may also have further heightened the risk that we would not have been able to achieve the expected return on our drug products or full value of our patents protecting our products if prices are set after such products had been on the market for nine years.
All entries for: Respiratory Diseases
Rein Therapeutics
Negative Outlook
Austin, TX
1-50 employees
Trevi Therapeutics
Negative Outlook
New Haven, CT
1-50 employees
Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain costly single-source drug products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond. This provision applies to drug products that have been approved for at least 9 years, but it does not apply to drugs that have been approved for a single rare disease or condition. Nonetheless, since CMS may establish a maximum price for these products in price negotiations, we would be fully at risk of government action if our products are the subject of Medicare price negotiations. Moreover, given the risk that could be the case, these provisions of the IRA may also further heighten the risk that we would not be able to achieve the expected return on our drug products or full value of our patents protecting our products if prices are set after such products have been on the market for nine years.
Third Harmonic Bio
Company Closure
San Francisco, CA
1-50 employees
Third Harmonic Bio has abandoned plans to take its chronic spontaneous urticaria (CSU) drug into phase 2, instead preparing to sell the asset while liquidating the business.
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
We expect to experience pricing pressures in connection with the sale of any products that we develop, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative proposals. 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. Only high-expenditure single-source drugs that have been approved for at least seven years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. Various industry stakeholders 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, future challenges in view of the U.S. Supreme Court’s overruling of the Chevron doctrine, changes in the leadership of the federal agencies, 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.
Teva Pharmaceuticals
Layoffs
Tel Aviv, Israel
10,001-50,000 employees
Teva is laying off some 2,900 of its employees worldwide by 2027, corresponding to an approximately 8% reduction in force, company executives announced Wednesday during the company’s first-quarter 2025 earnings report, according to various media reports. According to a subsequent Worker Adjustment and Retraining Notification notice and confirmed by a company spokesperson to BioSpace via email, 54 of the affected employees work in Salt Lake City.
Pliant Therapeutics
Negative Outlook
South San Francisco, CA
51-200 employees
The IRA explicitly excludes from price negotiation orphan drugs designated for only one rare disease or condition and for which the only active approved indication is for such disease or condition. Those drugs with multiple orphan designations are not excluded from drug price negotiation. As we are developing bexotegrast in multiple orphan indications and may seek obtain orphan drug designation for other product candidates, this aspect of the IRA could have a negative impact on our ability to rely on the orphan drug exclusion to the “maximum fair price”.
Pulmatrix Inc.
Negative Outlook
Framingham, MA
1-50 employees
Recently, the U.S. government passed the Inflation Reduction Act, which authorizes the U.S. Department of Health and Human Services to negotiate prices of certain drugs with participating manufacturers in federal healthcare programs. Adoption of such controls and measures and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceuticals. As a result, the marketability of any product which receives regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.
Pliant Therapeutics
Layoffs
South San Francisco, CA
51-200 employees
About two months after discontinuing the Phase IIb/III BEACON-IPF study of idiopathic pulmonary fibrosis drug candidate bexotegrast, Pliant Therapeutics announced it’s cutting roughly 45% of its workforce. The move is meant to help extend the San Francisco–based biotech’s cash runway to support execution of late-stage clinical trials. The company, which develops oral integrin inhibitors for fibrotic diseases, did not say how long that runway will last.
Medera
Negative Outlook
Boston, MA
51-200 employees
It is currently unclear how these judicial challenges as well as other legislative, executive, and administrative actions, including how the IRA will be implemented, will impact the pharmaceutical industry. 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.
GSK - Philadelphia
Negative Outlook
Philadelphia, PA
50,001+ employees
“HIV: HIV sales grew by 7% this quarter with the US growing at 9%. This was driven by a 9 percentage point increase in patient demand from Cabenuva, Apretude and Dovato reflecting strong market share growth. Growth in the quarter also benefited from customer ordering patterns, offset by unfavourable price impacts from channel mix adjustments and the impact of IRA Medicare Part D redesign. Nucala: Sales growth in the quarter was driven by strong performance across all regions, reflecting higher patient demand for treatments addressing eosinophilic-led disease. Growth in the quarter in the US was predominantly driven by the impacts of channel inventory reductions occurring in 2024, with further underlying double digit volume increases being largely offset by unfavourable price impacts, including the impact of IRA Medicare Part D redesign.
Trelegy: Trelegy sales continued to grow in the quarter, with strong volume growth continued across all regions reflecting patient demand, SITT class growth, and increased market share. Specifically in the US, continued strong volume growth is partially offset by price unfavourability resulting from channel mix and pricing pressures and the impact of IRA Medicare Part D redesign. US performance in the quarter reflected the introduction of the IRA Medicare Part D redesign, which adversely impacted a number of products across Specialty Medicines, Vaccines and General Medicines.”