‘We Did Too Good Of A Job’ On Lowering Prices: Sandoz’s Haruvi Discusses Generic Sustainability

As Hatch-Waxman celebrates its 40th anniversary, the chair of the US generic trade association talks about striking the right balance on supply and pricing, preventing shortages, and improving Medicare price negotiations.

AAM Access 2024 display
AAM’s annual meeting had a nautical theme as the industry plotted a course to stay above water. • Source: Nielsen Hobbs

The Association for Accessible Medicines’ annual meeting this year was in Tampa, Fla., and featured a nautical theme. Interim CEO David Gaugh appeared at the podium in a ship captain’s outfit, and stage displays evoked waves. The concept seemed grimly fitting for an indistry that says it is struggling to stay above water.

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US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 

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How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.