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Thirty years of the Patented Medicines (Notice of Compliance) Regulations

Pharma in Brief

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.

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Guidance on inventor discovery and “invention story” evidence in Canadian patent actions: Federal Court rules in favour of patentee

Pharma in Brief

Background All three decisions arose during proceedings commenced pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court concluded that there was no basis for such an Order in the Rules , the Regulations , or the jurisprudence.

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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device. Source link: [link] ov/.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our ambition is to be the world’s leading and most valued generics company. About Sandoz. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs.

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Sandoz announces plans to further strengthen its antibiotics manufacturing setup in Europe

The Pharma Data

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our ambition is to be the world’s leading and most valued generics company. About Sandoz. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine | Novartis

The Pharma Data

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our ambition is to be the world’s leading and most valued generics company. About Sandoz. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs.

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New Sandoz Board of Directors appointed

The Pharma Data

Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our ambition is to be the world’s leading and most valued generics company.

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