Injectable Leqembi permits weekly maintenance dosing of the Eisai and Biogen Alzheimer’s disease drug that may be done at a patient’s home. Other recent notable regulatory news includes several rare disease drug approvals and narrower FDA nods for Covid-19 vaccines.
A judge has approved Blue Cross Blue Shield's $2.8 billion settlement with providers. However, some providers are opting out, arguing that it doesn't go far enough.
This eBook provides actionable strategies, real-world best practices to help payers stay ahead in a value-based care environment.
Zemcelpro, a cord blood-sourced cell therapy developed by startup ExCellThera, received conditional marketing authorization in Europe as a treatment for blood cancer patients who can’t find a matched donor. It’s the first cell therapy approved in Europe for this group of patients.
Susan Monarez has been fired from her role as CDC director less than a month after her confirmation, following reported clashes with HHS Secretary Robert F. Kennedy Jr. over vaccine policy. This news comes amid a period of turmoil at the CDC, including a recent deadly shooting at its headquarters.
Valneva must immediately cease U.S. shipments and sales of Ixchiq, a vaccine for chikungunya virus. The FDA recently lifted a pause on dosing of Ixchiq, but the agency’s new safety alert is based on an assessment that found the vaccine appears to be causing chikungunya-like illness in recipients.
Precigen’s Papzimeos is the first FDA-approved drug for the rare disease recurrent respiratory papillomatosis, or RRP. While this immunotherapy carries blockbuster expectations, Precigen’s financial reports indicate budgetary challenges.
Scheduling software is helpful for wellness business owners in numerous ways. They get everything they need to create appointments, reschedule clients and track cancellations in one platform.
The FDA approved Ionis Pharmaceuticals’ Dawnzera for preventing swelling attacks caused by the rare disease hereditary angioedema. A Takeda Pharmaceutical product dominates this market, but Ionis has clinical data showing patients had better outcomes after switching to Dawnzera from Takeda’s drug and other currently available HAE medications.
Gilead Sciences, whose Kite subsidiary was one of the pioneers of ex vivo cancer cell therapy, is joining the pursuit of in vivo therapies with the acquisition of startup Interius BioTherapeutics. The deal follows AstraZeneca and AbbVie acquisitions this year for in vivo cell therapy developers.
As AI chatbots become a surrogate for human connection amid a national mental health crisis, experts are worried about these tools’ lack of safeguards — with research showing the models can provide dangerous, sometimes fatal, advice. Regulators and providers alike are scrambling to catch up with a technology that evolves faster than humans are able to understand.
Novo Nordisk’s GLP-1 drug Wegovy expanded its label to include the metabolic disorder known as MASH. Analysts say there’s room for many MASH drugs with the treatment landscape expected to shape up to include combinations of therapies bringing different approaches to this fatty liver disease.
There are a number of criteria for selecting the best autism therapy centers. Parents choosing a facility or professionals seeking to improve their offerings should consider certain standards to ensure the right fit.
The Trump administration is directing the Department of Health and Human Services to identify about 26 “critical medicines.” The federal government will stockpile active pharmaceutical ingredients for these products, which the administration contends will insulate the U.S. from foreign supplies while also encouraging more domestic API production.
Insmed’s Brinsupri is the first drug specifically approved for treating non-cystic fibrosis bronchiectasis, a progressive and potentially fatal lung disorder. The drug, licensed from AstraZeneca, inhibits activation of neutrophils, white blood cells that play a role in inflammatory and immune responses.
Boehringer-Ingelheim pill Hernexeos was awarded accelerated FDA approval for advanced cases of non-small cell lung cancer with HER2 mutations. But Bayer is on its heels with an oral small molecule currently under FDA review in the same indication.
As CMS ramps up its RADV initiatives in the months ahead, plans should ensure their risk adjustment programs meet the highest standards of accuracy and compliance. Prospective and retrospective analytics enhanced by AI can help plans work with providers to optimize documentation at the point of care and identify coding errors during audit preparation.
The Department of Justice has reached a proposed settlement with UnitedHealth Group and Amedisys regarding UnitedHealth’s acquisition of the home health provider, which includes the divestiture of 164 home health and hospice locations.