News

In COVID-19 news, the FDA issued an EUA for Novavax booster. The agency has extended review time for new ALS therapy and accepted a supplemental NDA for Camzyos. Additionlly, the FDA granted six months pediatric exclusivity for Eylea.

In COVID-19 news, the FDA has authorized updated boosters for younger children. The FDA also approved an at-home heart failure therapy, but issued a CRL for a Parkinson’s therapy. The agency has assigned PDUFDA dates for several BLA, including a hemophilia A gene therapy and Eylea for retinopathy in premature infants. Regulators have also announced an Adderall shortage. Additionally, a nonprofit company has begun the application process for OTC version of naloxone.

Marc Samuels and Lindsay Bealor Greenleaf of ADVI Health, LLC, say right now may not be the best time to move forward with this law as it could increase inflation through 2024. Samuels is CEO and founder of ADVI Health and is a member of MHE's editorial advisory board. Greenleaf is vice president and head of policy and reimbursement at ADVI.

Kevin Astle, Pharm.D., discussed on-demand HIV preexposure prophylaxis (PrEP), the advent of long-term injectables, and updated CDC guidelines at the AMCP Nexus 2022 meeting in National Harbor, Maryland.

The FDA uses real-world data to show how Boostrix prevents infections in infants. The agency also approves a label expansion for Oxlumo, a new administration method for Trogarzo, and accepts an sBLA for Takhzyro. In COVID-19 news, Eiger won’t submit EUA for COVID-19 treatment. Additionally, an OIG reports finds many accelerated approvals have delayed confirmatory trials.

The FDA has approved several new therapies this week, including Amylyx’s oral treatment for ALS, a fourth Avastin biosimilar, a new glaucoma treatment and another indication for Duxipent. The agency also accepted an NDA for therapy for rare immunodeficiency disease.

Jennifer Watts, M.D., M.P.H., chief emergency management medical officer, director of global health and a pediatric emergency medicine physician at Children’s Mercy Kansas City, a children’s hospital in Kansas City, Missouri is one of the 10 up-and-coming healthcare leaders featured in the annual Managed Healthcare Executive feature.