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

 
• By Nielsen Hobbs

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.

A white paper released at the conference is entitled “Hatch-Waxman turns 40. Is it over the hill? (Or is...

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More from Generics

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

More from Conferences

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 
• By Sarah Karlin-Smith

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.