article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

article thumbnail

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

The Pharma Data

The Sandoz division has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. About Sandoz.

article thumbnail

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

The Pharma Data

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. The Sandoz division has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development. About Sandoz.

article thumbnail

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

The Pharma Data

By modernizing and simplifying its manufacturing setup, Sandoz will improve its ability to consistently deliver high-quality medicines to patients, while remaining cost-competitive on the global market. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. About Sandoz.

article thumbnail

New Sandoz Board of Directors appointed

The Pharma Data

Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. He holds a Master degree in Marketing and Trade from the University of St. Our ambition is to be the world’s leading and most valued generics company. Gallen (HSG), Switzerland.

Sales 40