Contagion Editorial Staff

An original version of this article appeared on sister publication Contagion.

August traditionally kicks off back-to-school time in the United States, but this year presents challenges as the number of new, confirmed coronavirus cases increases each day in many parts of the country. Individual school districts and colleges debate the merits of in-school learning and weighing it with safety concerns.

School administrators, nurses and teachers are trying to develop plans to bring students back for in-school learning and try to keep everyone safe.

As everyone is still trying to navigate uncharted waters with highest stakes, MJH Life Sciences™ has created a webinar "

," scheduled for this Thursday, August 20, at 6PM EDT.

This one-hour live event with our panel of experts will discuss current US Centers for Disease Control and Prevention guidance, outline what a safe return-to-school plan looks like, talk pros and cons of adding COVID-19 to the list of state-mandated immunizations for children once a vaccine is available, and share advice on how to counsel parents through this confusing time.

This webinar will feature the top minds in the field including:


Panelist: Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN

Kenny is president and CEO of Med Ink Exec, LLC. With over 20 years of clinical training and experience, Kenny believes that well-educated patients and knowledgeable practitioners both contribute to improved health outcomes.

Hallas is a clinical professor and director of the Pediatrics NP Program at New York University Meyers College of Nursing. She has presented nationally and internationally on her research that focuses on improving healthcare outcomes for vulnerable children in the pediatric populations. Her current research is on Vaccine Hesitancy and Vaccine Resistance in prenatal women and mothers of young children.

Lipkin is an associate professor of pediatrics at the Kennedy Krieger Institute (KKI) and the Johns Hopkins School of Medicine, as well as KKI’s director of Outpatient Medical Services. Dr. Lipkin’s clinical and research careers have focused on the early identification, evaluation, and treatment of children and adolescents with developmental disabilities, including autism, learning, and attention disorders.

Attendees can ask our panel questions during the webinar.



Don’t miss out on this must-attend event! Sign up 

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Join us tomorrow for an informative discussion on CDC guidance and insights from medical experts on navigating a way back to in-school learning.

COVID-19 Webinar: Debating the Road Back to School

 The US Food and Drug Administration (FDA) has granted orphan drug designation to APX001 for the treatment of cryptococcosis.

APX001, a leading candidate developed by Amplyx Pharmaceuticals, is an antifungal that previously received orphan drug designation for the treatment of invasive candidiasis, invasive aspergillosis, coccidioidomycosis, and rare mold infections caused by Scedosporium spp, Fusarium spp, and Mucorales fungi (including Mucor spp, and Rhizopus spp). The FDA also previously granted Qualified Infectious Disease Product designation for APX001 for treatment of cryptococcosis, invasive candidiasis, invasive aspergillosis, and coccidioidomycosis, according to an Amplyx 

Cryptococcosis is caused by the fungus Cryptococcus and infects the lungs and central nervous system. Brain infections with Cryptococcus are called cryptococcal meningitis and most commonly infect people with weakened or suppressed immune systems, such as those with HIV/AIDS, Hodgkin's disease, or who have had an organ transplant.

"APX001 is a really exciting new potential treatment for serious life-threatening fungal infections," Ciara Kennedy, PhD, MBA, president and CEO of Amplyx Pharmaceuticals,

 in October 2017, when phase 1 data were released on APX001. "It is a small molecule inhibitor of an enzyme called GWT1 that's within the fungal cell, and it is very broad spectrum of activity because GWT1 is highly conserved across fungal species so we have now a tremendous amount of non-clinical data to support its activity."

The orphan drug designation allows APX001 7 years of market exclusivity in the US, and QIDP provides eligibility for Fast Track designation, priority review, and a combined 12 years of marketing exclusivity when combined with orphan drug designation.

"Orphan and QIDP designations highlight the potential for APX001 to address unmet needs of patients with rare, life-threatening infections, and with the FDA's recent addition of cryptococcal meningitis to its list of neglected tropical diseases, Amplyx has the potential to obtain a valuable Tropical Disease Priority Review Voucher from the FDA, creating additional value for Amplyx and its stakeholders," Kennedy said in a statement.

The FDA has granted orphan drug designation to APX001 for the treatment of cryptococcosis.