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The Issue with Reissue: PTE Edition

The FDA Law Blog

Specifically, the Court focused on the purpose: to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications. The question is important because the result of that determination could drastically reduce the amount of patent term to be restored.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. In 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said. If it’s a sole-source drug, it gets its own unique J-code.

FDA
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How eWizard’s July Release Transforms Pharma Content Workflows 

Viseven

The more detective novels by Agatha Christie you order, the more Amazon will suggest similar books from the same genre or author. The farsighted pharmaceutical companies are waking up to the importance of AI agents. Book a demo Frequently Asked Questions What is eVa AI Agent and how does it support pharma marketers? +

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The Importance of Modernizing Your Email Marketing Campaigns

Pharma Marketing Network

downloads, appointment bookings) Email heat maps and click maps These insights help marketers understand which content works, when to send messages, and how to refine future campaigns. These outdated approaches often result in low open rates, unsubscribes, and missed opportunities.

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Barriers are limiting UK childhood vaccination, say doctors

pharmaphorum

Skip to main content Tuesday 1 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

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STAT+: Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more

STAT

You could also take a moment to curl up with a good book or perhaps enjoy some scrumptious food. Food and Drug Administration Commissioner Marty Makary said the agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the U.S. See you soon.

FDA
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​How to win more B2B sales deals with Competitive Intelligence

Fuld

Prabhakant Sinha, co-founder of ZS Associates, emphasizes that “companies that can think deeply and act swiftly will turn decision velocity into a source of value creation.” 3 ​One of Fuld’s clients, a global pharmaceutical company, used AI-driven CI to monitor competitor drug launches.