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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

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

More from Conferences

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.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.