MSN Put On Hold As DC Appeals Court Freezes Generic Entresto Approval

Novartis Has Met ‘Stringent Requirements’ For Stay Of ANDA Approval Pending Appeal

MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US after the originator won a stay on the firm’s ANDA pending appeal from the US Court of Appeals For the District of Columbia Circuit.

Pause
• Source: Shutterstock: studiostoks

MSN Laboratories’ US Food and Drug Administration approval for its generic version of Novartis’ multi-billion-dollar Entresto (sacubitril/valsartan) heart failure powerhouse has been stayed for now by an appeals court in Washington D.C., in the latest twist in the firms’ complex, ongoing litigation.

The Indian firm won approval for its Entresto generic in late July in the wake of the agency denying a...

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

More from Legal & IP

ADHD

This is regarding ADHD.

GB-Leadership-Free: Article with 150 words (Time to read is < 1 min)

 
• By 

In the first cinematic chapter of J.K. Rowling’s wizarding world, young Harry Potter discovers his true identity and enters Hogwarts School of Witchcraft and Wizardry. This enchanting origin story sets the tone for a saga filled with magic, loyalty, and the power of choice.

MPP Finds Three More Partners On Key Hepatitis C Treatment

 
• By 

The Medicines Patent Pool has entered into a partnership with three companies for glecaprevir/pibrentasvir, a WHO-recommended treatment for people living with hepatitis C. The companies join previous generic licensee Mylan and originator AbbVie.

Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

 
• By 

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

More from Generics Bulletin

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C10

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C9

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C8

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.