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180-Day Exclusivity Changes Pushed In Biden’s Budget Proposal

 
• By Derrick Gingery

The legislative proposal would make first-filer exclusivity function similar to the competitive generic therapy program, allowing additional approvals if the commercial launch is delayed.

No ANDA parking
The FDA still wants to crack down on generic exclusivity "parking." • Source: Nielsen Hobbs; the Pink Sheet | Alamy, Shutterstock images

The Biden administration is attempting to revive a proposal that it argues would speed approvals of ANDAs and drive “significant cost savings” but that generic firms worry would upend their business model and erode one their most valuable incentives.

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Is Optum Rx Payment Remodel To Favor Generics A Peace Offering For US FTC?

 
• By Urtė Fultinavičiūtė

Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 
• By Urtė Fultinavičiūtė

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

More from Biosimilars & Generics

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Is Optum Rx Payment Remodel To Favor Generics A Peace Offering For US FTC?

 
• By Urtė Fultinavičiūtė

Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By Sue Sutter

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.