“U.S. government plans to rein in drug prices could discourage work in some of Novartis’s most promising areas of research, the Swiss drugmaker warned on Friday, urging Washington to rethink the “unintended” effects of its new rules… Lawmakers’ intention may be to favour sophisticated biologics over seemingly more conventional chemical drugs, but some of the most promising new treatment approaches belong to the latter group, said Victor Bulto, Novartis’s President Innovative Medicines for the U.S. market. “The most concerning piece in that legislation for us is the price setting after nine years for small molecules and 13 years for biologics,” Bulto told Reuters.”
All entries for: Oncology
April 27, 2023
Eli Lilly & Company
Negative Outlook
Indianapolis, IN
10,001-50,000 employees
10001-50000 employees
Disease Area: Multiple, Oncology
Drug Type: Biologic
April 26, 2023
Alkermes
Negative Outlook
Dublin, Ireland
1,001-5,000 employees
1001-5000 employees
Disease Area: Oncology
Drug Type: Small Molecule
January 20, 2023
Novartis
Negative Outlook
Basel, Switzerland
50,001+ employees
50001+ employees
Disease Area: Multiple, Oncology
Drug Type: Small Molecule
November 9, 2022
Xilio Therapeutics
Negative Outlook
Waltham, MA
51-200 employees
51-200 employees
Note: Xilio described the IRA in a risk section entitled “Current and future legislative efforts may limit the prices for our products, if and when they are licensed for marketing, and that could materially impact our ability to generate revenues”
Disease Area: Oncology
Drug Type: Biologic
November 9, 2022
Context Therapeutics
Negative Outlook
Philadelphia, PA
1-50 employees
1-50 employees
Concern Over Ability to Sell Product: “The passage of the Inflation Reduction Act of 2022 may negatively impact our ability to sell our product candidates, if approved, profitably”
Disease Area: Oncology
Drug Type: Biologic
November 8, 2022
Zymeworks
Negative Outlook
Middletown, DE
201-500 employees
201-500 employees
Concerns over Revenue Generation: “The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcarereforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved”
Disease Area: Multiple, Oncology, Therapeutics
Drug Type: Biologic
November 8, 2022
Adicet Bio
Negative Outlook
Boston, MA
51-200 employees
51-200 employees
Concerns on Profitability: “There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. For example, in August 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law… The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates”
Disease Area: Oncology
Drug Type: Biologic
November 8, 2022
Recursion Pharmaceuticals
Neutral Outlook
Salt Lake City, UT
201-500 employees
201-500 employees
“Adverse Effects”: “…the recently enacted federal Inflation Reduction Act (IRA) contains provisions that could have an adverse effect on our ability to generate revenue, attain profitability, or commercialize our product candidates if approved, as the statute includes provisions intended to reduce the cost of prescription drugs under Medicare. In addition to the direct impact of the IRA on federal drug reimbursement, the statute may also lead to similar reductions in payments from private payers. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect [List of items]”
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 8, 2022
IDEAYA Biosciences
Negative Outlook
San Francisco, CA
51-200 employees
51-200 employees
Concerns on Profitability & Revenue: “The implementation of cost containment measures, including the prescription drug provisions under the IRA, 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.”
Disease Area: Oncology
Drug Type: Small Molecule
November 8, 2022
Halozyme Therapeutics
Negative Outlook
San Diego, CA
201-500 employees
201-500 employees
Potential “Material Adverse Impact”: “In this dynamic environment, we are unable to predict which or how many federal policy, legislative or regulatory changes may ultimately be enacted. To the extent federal government initiatives decrease or modify the coverage or reimbursement available for our or our partners’ products, limit or impact our decisions regarding the pricing of biopharmaceutical products or otherwise reduce the use of our or our partners’ U.S. products, such actions could have a material adverse effect on our business and results of operations.”
Disease Area: Oncology
Drug Type: Biologic