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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.

Legislation United States

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

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.

Biosimilars Intellectual Property
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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.

Infectious Diseases Launches

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.

Manufacturing Compliance

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
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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.

Infectious Diseases Launches

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.

Manufacturing Compliance

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
See All

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.

Infectious Diseases Launches

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.

Manufacturing Compliance

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
See All
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