Cancer Drugs And Medicare: Range Of Impacts Expected From IRA Price Reforms

Alkermes discusses oncology drug spin-off, Lilly discloses decision to halt development of a small molecule drug, and AbbVie comments on pending Medicare price negotiation for Imbruvica.

Oral Cancer Drugs The Poster Child For IRA-Driven Challenges To Innovation? • Source: Shutterstock

The drug pricing reform provisions of the Inflation Reduction Act could affect the development and commercial performance of cancer drugs in many different ways and some of those came to light during recent quarterly earnings presentations by a handful of manufacturers.

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Newest HHS Staff Cuts Could Stymie CMS Health Plan Oversight

 
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.

Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department

 

About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.

German Ordinance To Implement HTA Reg Leaves Room For Doubt

 

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

Think Tank Suggests CMS, USTR Could Enforce Most Favored Nation, Other Drug Pricing Policies

 
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A Republican think tank suggested variations of the Most Favored Nation and international reference policies in Medicare and Medicaid, as well as tariffs and other trade levers to rebalance drug pricing disparities between US countries and abroad.

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Pink Sheet Podcast: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

 

Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.

EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.