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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
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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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Pfizer Responds to Research Claims

Pfizer

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

Research 112
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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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AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

The Pharma Data

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.