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The Same But Different: Biden Budget Proposes Flexibility For Generic Drug-Device Combos, ‘Skinny Labels’

 
• By Sarah Karlin-Smith

President Biden's fiscal year 2024 budget pushes new legislative changes to get generic drugs to market faster.

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FDA wants authority to approve generic drug-device combo products that have “certain differences” from the brand • Source: Shutterstock

The US Food and Drug Administration is seeking legislative changes that would permit it to approve generic drug-device combination products with “certain differences” in the device component compared to the brand.

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Tevogen Launches Generics-Focused Initiative As Trump Eyes Pharma Tariffs

 
• By Adam Zamecnik

As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By Dave Wallace

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

 
• By Dean Rudge

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

More from Products

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By Dave Wallace

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

 
• By Dean Rudge

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.