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Pharma’s 340B Dispute Resolution Arguments May Get Boost From Supreme Court’s Patent Ruling

 
• By Cathy Kelly

As stakeholders begin to mull the impact of the Arthrex opinion, HHS withdraws its advisory opinion concluding manufacturers are legally bound to provide 340B discounts to contract pharmacies, and Lilly takes aim at 340b contract pharmacy ‘replenishment’ model.

Recent Ruling May Have Relevance In 340B Litigation

US district court decisions on the constitutionality of the Health and Human Services Department’s 340B Administrative Dispute Resolution process might be impacted by the Supreme Court's recent ruling in United States vs. Arthrex.

In the Administrative Dispute Resolution process, described in a final rule released in December 2020, a board appointed by HHS...

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Under Trump, Antitrust Regulators May Be More Divestiture Friendly

 
• By Tim Casey

The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.

‘Chubby Labels?’: Generic Entresto Approval Was Lawful, D.C. Appeals Court Finds

 
• By Dean Rudge

MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.

Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations

 
• By Neena Brizmohun

Newly enacted standard contractual clauses for negotiating clinical trial agreements in Germany appear positive for sponsors compared to the clauses that trial sites were typically requesting in the past, eg, those relating to compensation for the transfer of inventions, according to lawyers.

Cease Fire: Vanda, US FDA Agree To Pause Hetlioz, Tradipitant Disputes

 
• By Sue Sutter

The agreement to resolve or stay numerous legal and administrative disputes resulted from a recent appeals court decision and the new agency leadership's receptiveness to negotiations, said Vanda, which has filed a barrage of challenges against the FDA in recent years.

More from Pink Sheet

‘Chubby Labels?’: Generic Entresto Approval Was Lawful, D.C. Appeals Court Finds

 
• By Dean Rudge

MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.

EU Pharma Package: Keep Patients Front & Center In Defining Unmet Medical Need

 
• By Francesca Bruce

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.

CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.