Category Archives: Policy News
BioUtah Joins State BIOs in Opposing Drug Price Controls
Senate Democrats are inching closer to a vote on a revived “Build Back Better” package, largely focused on drug pricing. The package would give Medicare the authority to negotiate drug prices and impose inflation rebates. The negotiation process, in practice, would function more like government price controls since drug manufacturers deemed non-compliant with the requirements […]
Senate Democrats Renew Plan for Drug Price Controls
Senate Democrats have renewed a push for drug pricing reforms, releasing on Wednesday proposed legislation along with a bill summary.
Sumitomo Pharma Oncology Receives Orphan Drug Designation for TP-3654, an Investigational Oral Inhibitor of PIM Kinases for the Treatment of Myelofibrosis
Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, recently announced that the FDA granted Orphan Drug Designation for TP-3654, the company’s proprietary investigational oral inhibitor of PIM kinases, for the treatment of myelofibrosis. “This designation is an important milestone in the development of TP-3654 and highlights the need for potential new treatment […]
Sumitomo Pharma Oncology, Inc. Pursues Research and Discovery with Persistence – Featured in Pharma Tech Outlook
Sumitomo Pharma Oncology, Inc. (SMP Oncology) and Steve Warner, Ph.D., Senior Vice President and Head of US Research at SMP Oncology, were recently featured in a Pharma Tech Outlook. In “Sumitomo Pharma Oncology: Discovering Immunotherapy Agents with Persistence,” Dr. Warner discusses SMP Oncology’s ongoing work in immunotherapy drug discovery, highlighting the progress with the Company’s […]
Sen. Romney Opposes Drug Importation as the Senate HELP Committee Advances User Fees
The Senate Health, Education, Labor and Pensions (HELP) Committee voted 13 to 9 on Tuesday to advance user fee reauthorization legislation.
Invest Lithuania
BioUtah has established a partnership with Invest Lithuania, an arm of the Lithuanian government focused on developing life sciences in their country. The life sciences sector in Lithuania is regarded as one of the most highly developed in Central and Eastern Europe (CEE). The sector is driven by innovation and aims to become Europe’s next […]
E&C Leaders Unveil FDA User Fees Legislative Package
Bipartisan Agreement Will Support Innovation, Lower Costs, and Improve People’s Lives Washington, D.C. – Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), and Health Subcommittee Ranking Member Brett Guthrie (R-KY) today unveiled a comprehensive legislative package to reauthorize the Food and Drug […]
CURTIS, CRAIG INTRODUCE BILL TO IMPROVE ACCESS TO GENERIC TREATMENTS
CURTIS, CRAIG INTRODUCE BILL TO IMPROVE ACCESS TO GENERIC TREATMENTS
Healthcare Priorities of President Biden’s FY23 Budget
On Monday, March 28, President Biden announced his budget for FY23, a $5.8 trillion proposal that reflects the administration’s funding priorities, many of which were drawn from the initial Build Back Better package. Congress is not required to adopt any or all of the president’s budget. However, each year, the president’s budget proposal serves as […]
FACT SHEET: The Biden Administration’s Historic Investment in Pandemic Preparedness and Biodefense in the FY 2023 President’s Budget
The Biden Administration’s Investment in Pandemic Preparedness and Biodefense in the FY 2023 President’s Budget
MDUFA V Agreement Reached
The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for MDUFA V. On March 22, FDA sent the commitment letter to Congress. Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years. FDA could receive additional funding […]
Senate HELP Committee Advances PREVENTS Pandemic Act
The Senate HELP Committee on Tuesday voted 20-2 to advance legislation, the PREVENTS Pandemic Act.
