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

Pharmacy Times

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.

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FDA approves label updates for BMS’ CAR T cell therapies

Pharmaceutical Technology

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.

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Advanced Solutions for Sustained Delivery of Ocular Therapies

PharmaTech

While treatments for infection, inflammation, high eye pressure, and neovascularization have been shown to be effective, this method of delivery is considered “off-label,” as FDA has not approved products specifically for this use, except two intracameral implants (see below). In addition, many patients are hesitant to receive eye injections.

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European Pharmacopoeia Goes Digital

PharmaTech

Thakar ; Varanya Chaiyaperm June 23rd 2025 Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Pluta ; Nishant B. Pluta ; Nishant B.

Dosage 59
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Priothera Awarded €1.7M in Innovation Contest for Hematologic Malignancy Treatments

PharmaTech

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development March 26th 2024 Podcast In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

Dosage 59
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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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How Pharmacists Can Use Artificial Intelligence To Advance Their Practice: Insights From ChatGPT

ID Stewardship

Patient Education and Adherence : AI chatbots or virtual assistants can be developed to provide patients with on-demand information about their medications, dosages, potential side effects, and adherence strategies. This empowers patients to make informed decisions and fosters better medication adherence.