Legal
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In Same Day, UCB Lands Two FDA Drug Approvals in Autoimmune Diseases
FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.
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Artificial Intelligence, BioPharma, Health Tech
FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech
The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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EU Orders Grail Sale; Illumina Continues Appeals But Plans for Multiple Outcomes
European Union regulators ordered Illumina to divest Grail. Illumina is appealing antitrust findings in Europe and the U.S., but the DNA sequencing giant revealed that divesting all or part of Grail is an option even if it wins both legal challenges.
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Is Medicare Advantage a Failed Experiment? Experts Debate
Enrollment in Medicare Advantage is increasing, but the program has been drawing scrutiny from the government. Can the program be saved? One expert believes Medicare Advantage is a failed experiment. Another thinks that while the program has its flaws, it shows tremendous potential.
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FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder
Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.
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Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study
Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond.
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Did Cigna Deserve its $172M Penalty?
Cigna recently agreed to pay $172 million to resolve allegations that it violated the False Claims Act. One expert said this is just a small part of the problem, while another called for more clarity from the government.
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FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots
Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.
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Invitae’s First of Its Kind Cancer Test Receives FDA Marketing Authorization
The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.
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Jorie Healthcare CEO Shares Why Automation is Critical to Revenue Cycle Management
The revenue cycle management business is using AI tools to automate cumbersome tasks to help hospitals operate more efficiently. It’s beginning to attract the attention of major healthcare organizations.
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C-SNPs: Promoting Healthcare Focused on Chronic Conditions
C-SNPs are Medicare Advantage plans formulated to meet the desired needs of people living with chronic diseases. These plans are different from traditional Medicare plans because they’re only available to people who fit the special needs category that the plan serves.
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4 States Received Enhanced Medicaid Funding During Covid Despite Wrongly Terminating Coverage
New York, Florida, Texas and Minnesota terminated Medicaid coverage for some enrollees for “unallowable or potentially unallowable reasons” during the Covid-19 public health emergency, according to a recent Office of Inspector General report.
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Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod
Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency. The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products.
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BrainStorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy
NurOwn, BrainStorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
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Nursing Homes, Beware! Supreme Court Greenlights Civil Lawsuits to Enforce FNHRA
The Supreme Court’s recent summer decision in Health and Hospital Corporation of Marion County, Indiana, et al. v. Talevski has raised the stakes for nursing homes by ruling that private litigants may bring civil claims against facilities to recover damages for violations of certain provisions of the Federal Nursing Home Reform Act (FNHRA). This decision provides powerful incentives for nursing homes and other facilities subject to the FNHRA to enhance their monitoring and compliance processes.
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Contamination Risk Sparks a Recall of GSK, Scynexis Antifungal Drug
Scynexis said no adverse events or contamination problems have been reported for Brexafemme, an antifungal approved for treating vaginal yeast infections. The biotech said the risk of cross-contamination stems from the processes of the small molecule’s third-party manufacturer.
Promoted
Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
Promoted
Navigating Healthcare’s Data Revolution: Priorities, Opportunities, and Challenges for Health Systems
Arcadia recently partnered with HIMSS Market Insights to survey executives, IT, technology, and clinical leaders. Here’s what we found.
