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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. for patients with NTRK fusion cancer across all solid tumors.

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government. According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC).

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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CSL doses first patient with haemophilia B gene therapy Hemgenix

Pharmaceutical Technology

Hemgenix works by dosing a patient with an engineered adeno-associated virus (AAV), containing the gene responsible for producing a protein called factor IX. Already a big player in haemophilia treatments, CSL licensed exclusive global rights to Hemgenix from gene therapy developers uniQure back in 2021.

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How patient-on-a-chip tech could be the future of drug discovery

pharmaphorum

In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinical development. Quris has taken its technology and used it to develop its own drug candidate pipeline. Organ-on-a-chip.

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Rocket Pharmaceuticals’ gene therapy receives FDA RMAT designation

Pharmaceutical Technology

It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas. The therapy has also received orphan drug and fast-track designations.

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Mental health apps and services may be doing more harm than good

World of DTC Marketing

DEA agents interviewed former Cerebral employees about clinician licensing issues and allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported , citing sources. The problems at Cerebral as Business Insider reported that the Drug Enforcement Agency (DEA) is investigating the company.

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