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Erasca receives fast track designation for glioblastoma therapy

Pharmaceutical Technology

Erasca has received the US Food and Drug Administration’s (FDA) fast track designation (FTD) for ERAS-801 to treat adults with glioblastoma (GBM) with epidermal growth factor receptor (EGFR) gene alterations. A team of three cancer researchers, Michael Jung, Timothy Cloughesy and David Nathanson, designed and developed ERAS-801.

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Orphagen’s ACC therapy receives FDA rare pediatric disease status

Pharmaceutical Technology

OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1). We currently plan to file an Investigational New Drug (IND) application with the FDA later this year to support the initiation of a Phase I clinical trial. “We

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The Power of Lipids: Enhancing Drug Delivery with Nanoparticles

Roots Analysis

In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

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Orserdu (elacestrant) Approved for Patients with ESR1 mutations in ER+/HER2- Advanced or Metastatic Breast Cancers

XTalks

Aditya Bardia, MD, MPH, director of Breast Cancer Research at Mass General Cancer Center, associate professor at the Medicine Department at Harvard Medical School and principal investigator for the EMERALD trial, in the same press release statement. In addition, about 40 percent of these cases involve mutations in the ESR1 gene.

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Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology.

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In the News: June 2021 Regulatory and Development Updates

Camargo

The UCLA researchers measured monoamine oxidase A (MAOA) gene expression in tumors from cancer patients and found that high MAOA expression was associated with shorter survival times and turned to a mouse model to investigate these observations with promising results.