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Intellectual Property

Sanofi CEO Calls For Patience And Faith In Pipeline Ahead Of Dupixent Expiry

Paul Hudson has acknowledged the firm’s R&D setbacks but says they are par for the course when tackling science ‘that has never been done before.’

EU-India FTA: Novel Drugs Cheaper, Will Novo Gain Edge Over Lilly?

Conclusion of India-EU talks sets ground for a free trade agreement to cut pharma tariffs, in turn lowering the cost for novel drugs like Novo’s obesity treatment Wegovy, though an investment protection agreement – likely influencing data exclusivity – will be concluded later.

India-EU Trade Deal: Lower Tariffs, Investment Protection Under Discussion

An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?

BMS To Continue Legal Action As Zydus Launches First Cut-Price Nivolumab Biosimilar In India

BMS will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company.

Teva Caves In Under FTC Pressure And Orders The Removal Of Improper Inhaler Patent Listings

After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.

David And Goliath: How A Parent-Led Buyers’ Club Challenged Cystic Fibrosis Giant Vertex

After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.

Dr Reddy’s Knocked Back On Canadian Semaglutide

Dr Reddy's had not ruled out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Canada Semaglutide Go-ahead: Which Way Will The Wind Blow For Dr Reddy’s?

Dr. Reddy's doesn’t fully rule out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Vertex’s Cystic Fibrosis Drug Trikafta Challenged By Buyers’ Club-Backed Beximco

Beximco said it will manufacture a generic rival to Vertex’s Trikafta, offering cystic fibrosis patients a much-needed cheaper alternative. However, people will be subject to domestic personal use importation laws to access the drug.

Big Patent Blow For Roche’s Evrysdi In India But It May Not Be Over Yet

Roche, which faced a high stakes patent setback for Evrysdi in India, appears to have appealed against a lower court’s ruling, which went decisively Natco’s way but also included distinct 'reservations' by the judges.

Gilead Settlements Push Back US Biktarvy Competition To 2036

Thanks to settlements with three generic challengers – Cipla, Laurus Labs and Lupin – Gilead says it has now kept competition to its $13bn Biktarvy brand off the US market until April 2036.

Dr Reddy’s And Hetero License Low-Cost Lenacapavir For LMICs

Under a pair of deals arranged through Unitaid, the Clinton Health Access Initiative and Wits RHI, as well as the Gates Foundation, Dr Reddy’s and Hetero will be able to sell low-cost generic versions of Gilead’s injectable lenacapavir HIV prevention treatment in LMICs.