Legal & IP
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.
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.
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.
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.
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.
Polpharma has struck a deal with MSN Laboratories that will see the Polish generics player distribute the Indian firm’s hospital portfolio in Poland.
Following the FDA’s approval of A 150mg version of Accord’ Herceptin biosimilar, the US agency has now greenlit a higher 400mg strength version of the rival.
With concern over the mpox health emergency continuing to build, the Medicines Patent Pool has offered its services to play a part in the global response.
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 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.
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.
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.
During Hikma’s first-half results call, the company delved into details of its strategic goals for biosimilars, small-molecule generics, injectables, GLP-1s and more.
With a clear focus on complex products, Lupin sets out its launch plans for the year ahead, while battling ongoing litigation over some of its generics.
Sandoz has delivered the first denosumab biosimilar launch in Canada, introducing its Jubbonti and Wyost rivals to Amgen’s Prolia and Xgeva.
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.
Sandoz has celebrated a US FDA approval for its Enzeevu biosimilar rival to Eylea. However, ongoing court proceedings make launch timing uncertain.
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.
A Hatch-Waxman case in Delaware stemming from AMTA Labs’ proposed generic version of Upsher-Smith’s Qudexy XR (topiramate) extended-release capsules has closed with a swift settlement.
“The principles of fairness in procedural conduct, especially in commercial disputes, is crucial,” Delhi’s High Court told Zydus Lifesciences as it agreed to temporarily block the sale of the firm’s recently launched biosimilar to Roche’s Perjeta.