Remove Hormones Remove Protein Remove Regulation Remove Trials
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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen. AstraZeneca stated that its NDA is being reviewed under Project Orbis.

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COVID-19 and Melatonin: Researchers Use AI To Study New Treatment Option

XTalks

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

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Novel hot flushes treatment approved in UK and EU

Drug Discovery World

Despite VMS, or hot flushes, being a common symptom of menopause, until now, hormone replacement therapy (HRT) was the only treatment. Lack of scientific advancement Before menopause, there is a balance between oestrogen, and the protein neurokinin B (NKB), which regulates the brain’s temperature control centre.

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Could GLP-1 receptor agonists treat addiction and dementia?

Drug Discovery World

Semaglutide manufacturer Novo Nordisk reported earlier this month that the drug reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity, as shown in the SELECT trial. GLP-1 is a hormone that is produced naturally in the brain and the gut in response to food ingestion.

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Why the Potential Effects of COVID-19 Vaccines on the Menstrual Cycle Are Not Concerning

XTalks

Currently, there is no scientific evidence to suggest that the vaccines induce any hormonal changes that would lead to irregular periods. This is because the processes that maintain the uterine lining, including the placenta, during pregnancy are different than those that regulate the normal menstrual cycle.

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World Glaucoma Week 2024: New Advances in Glaucoma Care

XTalks

XTALKS WEBINAR: Addressing Ophthalmology Clinical Trial Design and Effective Data Monitoring Committee Strategies On-Demand: Thursday, February 8, 2024 Register for this free webinar gain insights into statistical data strategies for ophthalmology clinical trials and learn best practices for establishing and reporting ophthalmic data.