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Biosimilar Launches Depend Mostly On Patents After Supreme Court Ruling

 
• By Brenda Sandburg

US high court says biosimilar sponsors do not have to wait until after FDA approval to start countdown clock for marketing, but patent litigation may impede launches.

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The US Supreme Court has given bosimilar sponsors the opportunity to launch immediately after approval but they still could be delayed by patent battles and strategic considerations.

In its unanimous June 12 opinion in Sandoz Inc. v. Amgen Inc

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OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 
• By Anju Ghangurde

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Deal Watch: FTC Keeps Current Merger Guidelines In Place, For Now

 
• By Joseph Haas

Plus deals involving Incyte/Genesis, Merck & Co./Epitopea, Merck Serono/Asceneuron, Tivic Health/Statera and more.

India Digital Personal Data Protection Norms: What It May Mean For Clinical Trials, Big Pharma GCCs

 
• By Anju Ghangurde

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader outline key compliance aspects that pharma and their global capability centers may need to factor as India moves to strengthen the framework for the protection of digital personal data.

More from Business

Industry Makes Its Case To Trump In Effort To Sidestep Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a 232 investigation.

Copycats Compound Novo’s Wegovy Growth Problems

 
• By Andrew McConaghie

The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.

Stock Watch: Market Optimism Outshines Q1 Currency And Tariff Woes

 
• By Andy Smith

The weak US dollar helped some companies reporting first-quarter results and hindered others reporting in stronger currencies. But even the impacts of currencies and Medicare modernization on first-quarter revenues were overlooked when an end to the trade wars seemed possible.