Xellia has added a 500mg/100ml variant to its range of vancomycin ready-to-use bags in the US, while Kabi has introduced ertapenem 1g vials and struck a critical-care supply deal with Vizient.

Patent litigation settlements have paved the way for Endo’s Par and Teva to secure the first US approvals for generic versions of Novartis’ Afinitor everolimus brand.

Amneal has become the first company to secure US approval for, and to launch, a generic alternative to Merck & Co’s top-selling, off-patent NuvaRing contraceptive device in the US. Other generics developers appear to be several months behind.

The International Generic and Biosimilar Medicines Association has urged the World Intellectual Property Organization to withdraw its support for a global database of pharmaceutical patent information. The Pat-INFORMED database – which is comprised of intellectual-property information provided by originators – contains unverified data and lacks appropriate safeguards, the IGBA contends.

China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.

The first of around 260 patients for a clinical trial comparing its PB006 natalizumab biosimilar candidate to Biogen’s Tysabri reference brand have been recruited by Polpharma Biologics, which has just added Karsten Roth and Alexandra Moulson to its team.

Using its Indian back-office function to realize synergies from acquired sales and marketing assets in western Europe forms a key part of Advanz Pharma’s growth strategy.

Finding a consensus across European stakeholders on how best to recognize and reward the benefits of value added medicines is key to the sector’s success, says Arun Narayan – chairman of the value added medicines sector group at Medicines for Europe and also head of global portfolio strategy and head of European business operations at Mylan – in an exclusive interview with Generics Bulletin.

Rovi hopes by the end of this year to file a hybrid marketing authorization application in Europe for a once-a-month sustained-release injectable formulation of risperidone. A US filing is scheduled for the first half of next year.