Pharmacy Times

JUNE 23, 2025

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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Pharmacy Times

JUNE 19, 2025

SHOW MORE With robust pipelines, cell therapy remains the major driver for drug development. The field is expanding into autoimmune diseases, with nononcology trials representing 51% of the pipeline by late 2024. Trends Pharmacol Sci. 2024;45(5):406-418. doi:10.1016/j.tips.2024.03.004

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PharmaTech

JUNE 24, 2025

The LNP-encapsulated small interfering RNA (siRNA) was approved by FDA for the treatment of hereditary transthyretin amyloidosis (ATTR), and this opened the door for mRNA-based drugs in many applications. Top 8 mRNA Vaccines and Therapeutics Companies.

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PharmaTech

JUNE 27, 2025

Accelerating drug development In other Aenova news, the company launched its Aenovation program for the acceleration of drug development in May 2025 (2). The program is designed to fast-track early development of drug formulations, especially to combat bioavailability and solubility challenges.

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PharmaTech

JULY 7, 2025

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.

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PharmaTech

JUNE 20, 2025

Abbott’s pact focuses on localizing pharma manufacturing, biosimilar development, and advancing UAE’s digital health initiatives. BI’s OpnME platform access aims to enhance Abu Dhabi’s clinical research by providing compounds, networks, and collaboration tools.

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PharmaTech

JUNE 23, 2025

Among the authorized medicines are six biosimilars and two generic drugs. These approvals bring the total medicines approved for authorization in 2025 so far to 56. Austedo (deutetrabenazine) was granted marketing authorization for the treatment of adults with moderate-to-severe tardive dyskinesia.

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