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Policy and Regulation
Regulation Explore this Topic
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AAM Criticizes Lower Health Care Costs Act
Reforms to the US 180-day exclusivity incentive included in the Blocking Act that is part of the Lower Health Care Costs Act could cost the US healthcare system approximately $1.7bn, the AAM has warned.
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.
US Biosimilar Sponsors Seek Off-The-Record Discussions
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.
Pricing Strategies; Reimbursement 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.
Teligent Slammed By FDA Warning Letter
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
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.
Intellectual Property 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.
Teligent Slammed By FDA Warning Letter
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
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.
Market Intelligence 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.
Teligent Slammed By FDA Warning Letter
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
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.
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