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The FDA has approved a rare disease therapy and an additional indication for Enhertu, and grants priority review for Imfinzi in biliary tract cancer. Regulators have issued complete response letters for three therapies. The agency also has scheduled an advisory committee for Nuplazid in Alzheimer’s psychosis.

At the 2022 Asembia Specialty Pharmacy Summit, healthcare policy experts at Avalere shared insights into the politics of a less ambitious Build Back Better bill and the healthcare provisions it might include. If a "skinny bill" doesn't get passed, the healthcare action of the Biden administration might shift to CMS Innovation Center and payment models, including a successor to the Oncology Care Model, they said.

Jayne Hornung, Chief Clinical Officer, Pharmacy, MMIT addresses the difference between digital therapeutics in the pharmacy and medical benefit space, and digs into the potential causes of the slow uptake in digital therapeutics among payers during this year's Asembia Specialty Pharmacy Summit in Las Vegas.

Doug Long, vice president of Industry Relations at IQVIA spoke on how the current inflationary trend in the economy affects healthcare spending and prices, as well as the trend of specialty drugs accounting for half of the drug spend in healthcare. Hear more of what he shared with our team at this year's Asembia Specialty Pharmacy Summit in Las Vegas.

Tracy Russell, senior director of state government affairs at CoverMyMeds addressed what piece of new federal legislation will have the biggest effect on specialty pharmacy and what the Biden administration's emphasis on healthcare equity will do for specialty pharmacy. Russell spoke more on this topic at this year's Asembia Specialty Pharmacy Summit in Las Vegas.

It’s been a busy week at the FDA. The agency has approved mavacamten for hypertrophic cardiomyopathy, an oral therapy for yeast infections, an additional indication for Ultomiris, Rinvoq and Veklury. Additionally, Moderna seek EUA for vaccine for young children and the FDA will hold an advisory committee meeting for both Xphozah in kidney disease and Novavax’s COVID-19 vaccine.

Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.