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PTAB Clears Path For Earlier Generic Zytiga Launch

 
• By Brenda Sandburg

Patent Trial and Appeal Board finds that the patent covering the blockbuster prostate cancer drug is unpatentable, which could allow generics to launch at-risk in October once they obtain FDA approval; at least 12 firms have pending ANDAs.

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Johnson & Johnson could face generic competition for its blockbuster prostate cancer therapy Zytiga (abiraterone acetate) as early as October now that the composition and method of use patent covering the drug has been found unpatentable by the US Patent and Trademark Office's Patent Trial and Appeal Board.

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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.

Semaglutide In 2027 Medicare Price Negotiations; Most Other Drugs Lose Exclusivity By Then

 
• By Mandy Jackson

Novo took the biggest stock price hit of all the drug makers with products subject to Medicare price negotiations in 2027 under the IRA, but at least 11 of its peers on the list will be subject to generic competition between 2025 and 2027.

Lens On Pharma Marketing ‘Ploys’ In India: Can The Genie Be Tamed?

 
• By Anju Ghangurde

India cracks down on unethical marketing practices, with AbbVie in the eye of a storm for allegedly violating norms. While the action sends the right signal, a wider clean up including in the devices segment, where things may be “more harmful” may not be easy, say some experts.

More from Business

Japan’s Ciconia Seeks Academic Candidates To Hatch In Global Market

 
• By Lisa Takagi

Japanese incubator Ciconia has just started verifying its first drug candidate with a vision of building domestic startups with globally competitive assets.

Sanofi Licenses Bispecific Candidates From AI-Driven Earendil

 
• By Joseph Haas

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Finance Watch: Investors Push ESSA Pharma, Elevation Oncology To Wind Down

 
• By Mandy Jackson

Restructuring Edition: ESSA and Elevation are reviewing strategic alternatives after trial failures, but each has an investor urging them to liquidate. Also, Third Harmonic and Vincerx are winding down, while Keros and Tempest are assessing options, but Opthea and OPM are cutting jobs.