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Category Archives: Policy News

BioUtah Recognizes 2023 Rare Disease Day

BioUtah on Feb. 28 joined Utah’s rare disease community, including patients, families and advocates, in recognizing 2023 Rare Disease Day at an inspirng event hosted at Recursion headquarters in Salt Lake City. Recursion CEO, Chris Gibson, along with BioHive Executive Director Aimee Edwards, kicked off the evening’s program which featured a panel of young rare […]

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HHS Releases New Payment Models for Prescription Drugs

HHS released on Tuesday, three new payment models that will be tested through the Centers for Medicare & Medicaid Services Innovation Center (CMS Innovation Center) to see whether they lower high drug costs under Medicare and Medicaid. The models are outlined as part of a larger HHS report conducted in response to an executive order […]

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HEALTHCARE POLICY FIGURES PROMINENTLY IN $1.7 TRILLION OMNIBUS GOVERNMENT FUNDING BILL

Congress is expected to vote this week on a massive omnibus government funding bill that would run through the end of the 2023 fiscal year. The legislative text was released on Tuesday. The $1.7 trillion, 4,155-page bill includes a number of significant healthcare provisions. Of particular interest to the life sciences industry are provisions included […]

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Sen. Lee Introduces Bill to Increase Patient Access to Biosimilars

On November 17, Sen. Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase patient access to biosimilars and reduce costs by easing switching studies required to allow a biosimilar to be substituted for a biologic. View a one-page summary HERE. Currently, pharmacists can substitute generics in lieu of their branded counterparts without […]

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Senator Mike Lee Introduces Bill to Roll Back Government Drug Price Controls

Senator Mike Lee (R-UT) has introduced the “Protecting Drug Innovation Act” which would roll back Medicare’s authority to set drug prices through a new punitive negotiation program. This government price-setting policy was a key component of the Democrats’ “Inflation Reduction Act” (IRA). The non-partisan Congressional Budget Office has estimated that the IRA’s drug pricing provisions […]

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Senator Mike Lee Urges Action for Transitional Coverage of Innovative Med Tech

Senator Mike Lee (R-UT) and a group of like-minded colleagues are preparing to send a letter to CMS Administration Chiquita Brooks-LaSure urging the agency to issue a proposed rule by year’s end to provide accelerated Medicare coverage for emerging medical technologies. Medicare patients should have timely access to innovative and beneficial care, which can change […]

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Senator Mike Lee Spends a Day in the BioHive

U.S. Senator Mike Lee (R-UT) on August 15 spent the day connecting with Utah’s life sciences community, known as the BioHive, touring facilities at BD, IONIQ Sciences, SEEK Labs and Carterra. His schedule also included a tour of Altitude Lab in the University of Utah’s Research Park where he led a roundtable discussion with nearly […]

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Tillis and Leahy Introduce Bipartisan Legislation to Improve Patent Quality

Tillis and Leahy Introduce Bipartisan Legislation to Improve Patent Quality

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Senate Democrats Push Drug Pricing, Tax, Climate Package

Sen. Joe Manchin (D-W. Va.) on Wednesday said he had signed off on a revised “Build Back Better” plan, renamed the “Inflation Reduction Act of 2022,” which includes sweeping drug price controls along with tax increases and billions for climate and energy spending. The bill’s drug pricing provisions would allow Medicare to negotiate drug prices […]

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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 […]

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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.

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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 […]

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