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.
The approval includes a REMS program because some patients experience a worrying drop in left ventricular ejection fraction.
About 6,000 attendees are expected for the meeting next week that will also have Adam Fein and Doug Long as featured speakers.
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.
Accurate data and comprehensive analysis enable health plans and healthcare providers to advance the safe use of medication.
Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.
Nearly all employers expect to offer virtual care to meet demand for medical and behavioral health services.
The U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) today to include pediatric patients 28 days of age and older.
Significant changes to Star Ratings are in store for 2023, which will directly impact health plans in many ways. For example, their ability to market to members year-round. Included are three things health plans should act on now to maintain or boost quality scores, plan growth and retention, and financial health.
Patient deductibles are likely to continue rising in coming years, and healthcare providers will have to implement strategies to continue providing patients with the best possible care.
The FDA has approved a generic of Zavesca for Gaucher disease and has accepted applications for a supplement indication for Enhertu and a novel therapy for CKD-related anemia. The regulatory agency also issued a CRL for Teva’s schizophrenia drug.
The company's services will be white labeled under the hospital system’s brand.
The World Health Organization now recommends Paxlovid and Veklury for non-severe COVID-19 at high risk of hospitalization but still advises against use in mild disease with low risk of hospitalization.
Despite missing the primary end point of significantly reducing oral corticosteroid dose, patients with asthma on Tezspire in the SOURCE trial received other benefits from the drug.
Enterprise imaging platforms would enable organizations to consistently and optimally capture, index, manage, store, distribute, view, exchange and analyze all clinical imaging and multimedia content, enhancing patients’ electronic health records.
Pediatric severe asthma is a heterogeneous disease and based on data, a multi-disciplinary approach can improve the diagnosis and management of these children.
As of early this year, as many as 23 million Americans may have developed long COVID, in which symptoms persist four or more weeks after first being infected with the virus. The condition is likely to have additional long-term effects that are not yet clear. However, the U.S. has begun to obtain a glimpse of long COVID’s far-reaching impact on those who suffer from it - and the picture is rather disturbing.
Big tech and its access to our data is a juicy target. But policy makers need to be careful or they will upend interoperability and turn back the clock on American healthcare.
Patients with cancer who have a poor prognosis may face obstacles in accessing critical pain medications.
Patients with lower heart rate variability during sleep may suffer from insomnia, the study found.
It is not yet clear whether Alzheimer’s causes excessive napping or vice versa, but the study’s authors say the questions are worthy of additional investigation.
Patients with obstructive sleep apnea who used continuous positive airway pressure devices were able to slow down their epigenetic age acceleration.
Dr. Caroline Carney of Magellan Healthcare discusses the psychedelics in the pipeline for treating mental health conditions.
Last month, the Centers for Disease Control and Prevention shared a draft update to its Clinical Practice Guideline for Prescribing Opioids. The proposed revision comes as the nation’s overdose death rate reaches an all-time high, fueled largely by the economic and psychological strains and lack of healthcare access caused by COVID-19.
As personalized medicine grows, so does the need for specialized management of laboratory testing.
In COVID-19 news, FDA issued an EUA for COVID-19 breath tests. The agency also okayed a third biosimilar of Avastin, extended the review of REGEN-COV, cleared first generic of Elcys, and accepted the BLA for Rolontis.
In this week's episode, Briana Contreras, editor of Managed Healthcare Executive, spoke with Dr. Paige Kilian, chief medical officer at Inovalon. In the discussion, Dr. Kilian broke down the current issues health plans are facing when it comes to risk adjustment and how it’s affecting members of these plans. She also shared some solutions that can help plans improve risk adjustment and quality programs with one in particular being health plans identifying care gaps through data and analytics.
A new report says the nation must take action to bring about the necessary changes. An industry group says it’s the most comprehensive study of nursing homes in more than three decades.
Fabric Health is bringing healthcare services to laundromats in Philadelphia and Pittsburgh. Other organizations are using barbershops and churches to deliver healthcare services and messages.
Five phenotype clusters were discovered to be associated with the exacerbation, or worsening, of chronic inflammatory airway diseases of asthma and chronic obstructive pulmonary disease (COPD), according to a recent study published in PLOS ONE.
