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Generics Explore this Topic

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Xellia and Kabi Broaden US Antibiotics Offering

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.

Infectious Diseases Launches

Endo And Teva Are First With US Everolimus

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.

 

Approvals Launches

Amneal Wins Race For US NuvaRing Rival

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.

Launches Gynecology & Urology
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Biosimilars Explore this Topic

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IGBA Urges WIPO To Revoke Patent Database Support

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.

Intellectual Property Generic Drugs

Bio-Thera Gets Chinese Nod To Proceed On Ustekinumab

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.

Biosimilars China

Polpharma Pursues Tysabri Through Antelope Trial

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.

Biosimilars Clinical Trials
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Value-Added Medicines Explore this Topic

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Advanz Sees Mumbai Center As Strategic Strength

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.

Business Strategies M & A

Consensus Is Essential To Find Best Value-Added Path

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.

Value-Added Medicines Regulation

Rovi Is Weeks From Long-Acting Risperidone Filing

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.

Value-Added Medicines Neurology
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