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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

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). This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government.

Drugs 264
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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.

Licensing 252
Insiders

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Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. Regulatory concerns remain Overall, microbiome research has not advanced as much as expected, which is partly due to safety issues, says Hota.

Bacteria 278
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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity. Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations.

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

Camargo

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Trial of Jazz’ cannabis drug in glioblastoma will start next year

pharmaphorum

The three-year phase 2 trial will be carried out by researchers at Leeds University led by professor of clinical oncology and neuro-oncology Susan Short, and see if adding Sativex (nabiximols) to standard chemotherapy for recurrent glioblastoma can extend survival. Jazz acquired rights to Sativex when it completed its $7.2

Trials 136
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Radioligand therapy pipeline with in-license for compounds targeting Fibroblast Activation Protein (FAP)

The Pharma Data

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. Disclaimer. Source link:[link].

Protein 52