Legal
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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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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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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.
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How MIPS Value Pathways will Prove the Value of Rehab Therapy
As value-based care models take hold, the time is ripe for rehab therapists to position themselves as primary players in the movement toward delivering optimal quality and value in the broader healthcare ecosystem.
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HHS: Medicaid/CHIP Coverage To Be Reinstated for 500K People
Thirty states have been conducting Medicaid and CHIP automatic renewals incorrectly, leading to many individuals being wrongly removed from coverage. Because of this, nearly 500,000 children and other individuals will have their coverage reinstated.
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FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.
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BeiGene, Novartis Drug Alliance Ends; It’s Their Second Terminated Deal This Year
BeiGene welcomes the return of the immunotherapy’s rights as an opportunity to make it the backbone of its solid tumors strategy. But Novartis cedes an opportunity to gain a competitor to established cancer immunotherapies from Merck and Bristol Myers Squibb.
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How the FTC Is Tackling ‘Below the Radar’ Healthcare Deals
The Federal Trade Commission only gets notified when a merger/acquisition deal value is above $100-$110 million, so smaller deals nonetheless lead to a slow consolidation of the market. In conference remarks, FTC Chair Lina Khan outlined the ways in which the agency is trying to counter this phenomenon.
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FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class
FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.
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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.
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Introducing MedCity FemFwd, a New Podcast on Women’s Health
MedCity News is launching a new podcast called MedCity FemFwd, which will discuss the breakthroughs and challenges in the women’s health space. In the inaugural episode, Michelle Long of KFF examines whether Opill — the first daily oral contraceptive approved for nonprescription use in the U.S. — will be covered by insurance.
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Civil Rights Groups File Complaint Against Florida for Medicaid Redeterminations Process
More than a dozen civil rights organizations alleged in a new complaint that Florida uses administrative practices that are preventing underserved communities from renewing their Medicaid coverage.
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Is Medicaid Expansion Still a Political Wedge Issue?
When Medicaid expansion was first enacted, it was a hot topic debate between Democrats and Republicans. But more and more states are starting to expand Medicaid, including several conservative states.
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Senators Introduce Bipartisan Bill To Impose Harsher Penalties On Those Who Assault Healthcare Staff
This week, senators introduced a bipartisan bill that would make it a federal crime to assault hospital workers. Even though nearly 40 states have passed laws to intensify penalties for violent acts committed against healthcare personnel, there is currently no federal law protecting hospital employees from assault or intimidation.
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How 4 Mental Health Firms Want the DEA to Handle Virtual Prescribing of Controlled Substances
Talkiatry, Array Behavioral Care, Iris Telehealth and Quartet Health sent a letter to the DEA asking for a special registration process that would allow for the prescribing of certain controlled medications via telemedicine.
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FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants
The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.
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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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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
