A recap of notable FDA decisions in 2022

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Top Story Drug Approvals in 2022: A Recap of Notable FDA Regulatory Decisions Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year. Have You Submitted Your Application? INVEST 2023 Pitch Perfect Applications    There is no fee to apply. Only companies funded from 2018-2022 (no more than five years ago), and that have raised a seed funding round will be considered. Startups can apply to only one track. Startups must be registered for the conference in order to participate in the pitch contest. There are five tracks and each track will feature six finalists. Application Deadline: January 30, 2023. Applications will be reviewed by investment professionals and selections announced on Feb. 21, 2023.   Apply Now!

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AVS Rakes in $20M to Advance Plaque-shattering Arterial Disease Treatment Boston-based medical device company AVS recently raised $20 million in Series B funding to bring its arterial disease treatment closer to FDA clearance. The system that AVS is developing uses pressure waves to shatter calcium that has built up in arteries. Centene, Western Sky Community Care Donate $3M for Project Serving Unhoused The donation will go to the One Albuquerque Fund for its project called "The Gateway." This project will create a new medical center that will provide emergency overnight beds and other services for those experiencing homelessness. Tumor-Zapping Device Scores in Pivotal Study, Sends Shares of Novocure Soaring Novocure's electrical field-producing medical device, in combination with standard drug therapies, improved overall survival in a pivotal study that enrolled patients with advanced non-small cell lung cancer. The medtech company now plans to seek regulatory approvals. Season Health, HealthAlign Partner To Provide Nutrition Benefits to MA Beneficiaries Through the partnership, food and meals will be offered as a service on HealthAlign's marketplace. Season Health will provide those services to about 5,500 members a month of three out of the six largest Medicare Advantage plans. Timely Referrals to Hospice Can Help Patients with Advanced Lung Disease Breathe Easier There's a lingering misperception among many patients, loved ones, and even healthcare professionals that hospice care is useful only in a patient's last days or weeks of life. Healthcare's Digitization: Coming to Terms with Cybersecurity Supply Chain Risk Providers are, in many cases, getting the equivalent of a Russian nesting doll of third-party risks whenever they acquire a complex new technology solution. Cybersecurity supply chain risk management is the process of identifying and mitigating potential risks that may arise from these third-party products and services within an organization's IT infrastructure. Leaning In: How eCOA can Help Advance Mental Health Research Electronic Clinical Outcomes Assessment and digital health tools were well-suited to accommodate the rapid rise of virtual and telehealth shifts during the Covid-19 pandemic and there is no going back. The adoption of eCOA technology in mental healthcare research can make pivotal advancements in mental health patient care. 3 Steps CMS Can Take to Rein in Misleading MA Marketing By creating a marketplace that empowers consumers to choose the right health care coverage for their unique and individual needs, CMS will continue to put consumers first and strengthen Medicare Advantage, already the chosen program of America's seniors.

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