Morning RX: June 9, 2023


Advisers with the FDA endorse a monoclonal antibody treatment for RSV in children, AstraZeneca and Quell sign a $2 billion agreement, and HSS hopes to strengthen the pediatric workforce.

FDA Advisory Committee Endorses RSV Antibody Treatment for Infants

Members of the FDA’s Antimicrobial Drugs Advisory Committee voted Thursday to endorse a monoclonal antibody treatment to prevent RSV in infants and children up to 24 months, CNN reported. Developed by AstraZeneca and Sanofi, nirsevimab is given as a single shot to infants at birth or at the start of their first RSV season. It was also designed to be given as a larger dose to highly vulnerable children during their second RSV season. Nirsevimab was shown to reduce the risk of RSV-linked lower respiratory tract infections by around 75%, as well as RSV-related hospitalization by about 78%, in clinical trials.

AstraZeneca and Quell Partner to Develop Cell Therapies

AstraZeneca and Quell Therapeutics have signed a $2 billion agreement to work on the development of several engineered cell therapies that could help cure type 1 diabetes and inflammatory bowel disease, the pharmaceutical company announced Friday. The agreement will see Quell leverage its toolbox of treg cell engineering modules to develop autologous multi-modular treg cell therapy candidates for major autoimmune disease indications.

“This is a very exciting collaboration with Quell as we look to expand our next-generation therapeutic toolbox and explore the untapped potential with Treg cell therapies in autoimmune indications,” said Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca. "This is aligned with our strategy to target underlying disease drivers to stop or slow disease progression and ultimately accelerate the delivery of transformative care to patients with chronic autoimmune conditions.”

HHS Launches Loan Repayment Program for Pediatric Workforce

The US Department of Health and Human Services has launched a $15 million loan repayment program in an effort to help retain and bring new clinicians into pediatric healthcare, the department said Friday. In order to be eligible for the program, clinicians will need to work in a health professional shortage area, medically underserved area, or provide care to a medically underserved population for 3 years. Clinicians who are eligible for the program could receive up to $100,000 to help pay off their student loans.

"In order to improve access to care for children and young people in underserved areas, we need to expand the health care workforce," said HHS Secretary Xavier Becerra. “Through the Pediatric Specialty Loan Repayment Program, we will be able to recruit and train new doctors, nurses, counselors, and other health professionals, and improve health outcomes for young people.”

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