Legal Issues

India Rare Diseases: Court Shows Path For Policy Action, Funding, Price Issues-- Test-2

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.

Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

 
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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.

FTC Makes Double Reverse Payment Case Against Endo And Impax

 

The generics firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.

Stada Settlements Secure Squeeze-Out

 
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Nidda Healthcare, the investment vehicle controlled by Bain Capital and Cinven, has secured a “timely” squeeze-out of minority shareholders in Stada through settlement terms that include a one-time payment of €0.10 per outstanding share for the remaining shareholders.

TEST: Samsung Bioepis Hit With Denosumab Lawsuit

 

Amgen has asserted 34 patents for alleged infringement against Samsung Bioepis, which is the highest number out of the three lawsuits filed by the originator against a denosumab biosimilar maker.

US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide

 
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An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.

News We’re Watching: $1B Judgement Against J&J Recalls For Abbott, Baxter, More; Karl Storz Announces Fujifilm Partnership

 

This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.

Sandoz Pulls US Sunosi ANDA, With Competition Still In The Distance

 
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Sandoz’s withdrawal of its ANDA referencing Axsome Therapeutics’ Sunosi sleep disorder drug leaves potential competition years in the future, although other ANDA filers continue to circle.

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

 
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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.

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

 
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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.

Shuren Faces Calls For Investigation On Conflict Of Interest Claims

 
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Former FDA device center head Jeffrey Shuren is facing conflict of interest claims for not recusing himself from regulatory decisions involving clients of his wife’s legal firm. Critics call for an investigation and stricter ethics compliance.

Biogen Accused Of ‘Paying’ PBMs To ‘Manipulate’ US Generic Tecfidera Market

 
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Spooked by the prospect of earlier-than-expected US generic competition to its powerhouse MS brand Tecfidera, Biogen entered into illicit agreements with PBMs to stifle generic competition while it “scrambled” to switch the market to its follow-on brand, a US class action lawsuit alleges.

Samsung Bioepis Hit By Amgen Denosumab Lawsuit

 

Amgen has asserted 34 patents for alleged infringement against Samsung Bioepis, which is the highest number out of the three lawsuits filed by the originator against a denosumab biosimilar maker.

‘Inside Regulatory Affairs’ With AESGP’s Christelle Anquez-Traxler and Oliver Hartmann

 
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HBW Insight presents a new series profiling regulatory affairs specialists working in or supporting the consumer health and cosmetics industries. In this first installment, we speak to AESGP's Christelle Anquez-Traxler and Oliver Hartmann, senior regulatory science & strategy lead, and regulatory & legal affairs director respectively. 

US Court Pulls No Punches At It Denies Novartis Bid To Block MSN’s Entresto Generic

 
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A US district court in Delaware was at times withering in its appraisals of Novartis’ defenses as it refused to grant an order that would block ANDA sponsor MSN Labs from selling a generic version of the multi-billion-dollar blockbuster Entreso.

False Claims Collections Top $1B In First Half Of Year

 
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The US government continued its focus on False Claims Act enforcement and collected funds totaling more than $1bn in the first of this year alone – $155m of which was medtech-related. 

Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
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Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

Sandoz Bolsters US Ophthalmic Portfolio With Aflibercept Approval

 
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Sandoz has celebrated a US FDA approval for its Enzeevu biosimilar rival to Eylea. However, ongoing court proceedings make launch timing uncertain.

Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
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Citizen petitions, Hatch-Waxman, and now a lawsuit against the FDA itself: Novartis continues to fight tooth and nail to protect its core $3bn Entresto brand in the US, following the latest agency approval of a generic version. Generics Bulletin dives into the originator’s complaint against the FDA.

Philips Says Outside Lab Screwed Up, Then Covered Up Testing Results Of Ventilator Foam

 

Philips has filed a lawsuit against a Pennsylvania lab it hired to analyze sound abatement foam that prompted widespread recalls of its CPAP machines. Philips alleges PSN Labs grossly overestimated the risk to patients, which led Philips to initiate a larger recall than it otherwise would have.

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