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Which Came First? Alogliptin Avoids Possible Exclusivity Dispute

 
• By Michael McCaughan

An unusual footnote in FDA’s approval letter for Takeda’s long-delayed diabetes medicine means that the company won’t have to worry about losing five-year exclusivity on the molecule.

You can forgive Takeda Pharmaceutical Co. Ltd. for perhaps feeling very little by way of gratitude when FDA granted approval to the type 2 diabetes agent alogliptin in January. After all, the company had been waiting more than five years: Takeda filed the NDA in 2007 — just in time for the drug to get caught in the suddenly rising bar for type 2 diabetes drugs in the wake of the Avandia controversy. Also see "Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor" - Pink Sheet, 1 October, 2008.

Indeed, of all the products affected by that flap, alogliptin arguably suffered the most (except for Avandia itself): while other agents, including Bristol-Myers Squibb Co.’s directly competing saxagliptin, managed...

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Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.