News

In COVID-19 news, the FDA grants EUA for Novavax’s COVID-19 vaccine. The agency approved a novel diagnostic dye and another indication for Xalkori, but delayed a decision on a therapy for esophageal cancer. FDA has also accepted a BLA for advanced HER2 breast cancer therapy. Finally, Can-Fite BioPharma plans submission for psoriasis therapy.

A novel therapy in early development aims to permanently turn off the PCSK9 gene in the liver and lower cholesterol with a one-time treatment. It is being developed for a genetic form of high cholesterol.

Although the Oncology Care Model produced some positive results, the value-based care model cost Medicare money. Now attention is turning to its successor, the Enhancing Oncology Model.

The Big Three all set up group purchasing organizations recently, but some industry observers question the timing of the move and who will benefit.

As Congress considers legislation that would cap out-of-pocket costs for insulin, Walmart and Civica Rx are taking steps that could make less expensive versions of the diabetes medication more available.

The FDA expands label for Krystexxa. Agency has granted priority review for two therapies: lecanemab for Alzheimer’s disease and a novel immunotherapy for follicular lymphoma. The FDA will convene a second advisory committee for ALS therapy. Additionally, Bausch + Lomb submits NDA for dry eye disease therapy.

Bispecific antibody therapies are also in development.

One trend to keep an eye on is the establishment of “care traffic control” centers to remotely monitor patients and use home-based insights to identify risks and inform care plans.

The increases had no impact on the efficacy of the drug and were rarely associated with symptoms or sequelae.

The United States has acquired adult and pediatric doses of the COVID-19 vaccine for delivery in early fall in a contract worth $3.2 billion, as well as an additional 150,000 doses of bebtelovimab for about $275 million.

In COVID-19 news, the FDA has declined an EUA request for Zyesami and Pfizer has submitted NDA for Pavlovid. The regulatory agency has accepted several applications, including an sBLA for Eylea in diabetic retinopathy and the NDA for palovarotene for a rare genetic disorder. The FDA also issued a CRL for a UTI therapy and extended the review of diabetes therapy. And finally, Gilead has resubmitted its twice-year HIV therapy.

By using a combination of predictive and prescriptive next best action insights, providers can close the gap in care for individual patients by leveraging a combination of data sources — clinical data, patient surveys, SDOH data, and consumer and behavioral data sets — and applying artificial intelligence techniques to create those insights.

The companies issued statements referencing out-of-state abortions and travel benefits. Both are in headquartered in states with strong abortion rights laws.

Improving interfacility patient movement is an art and a science: to be well-executed, it requires clinical judgment and aggregated data.

Zelnorm is used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation.

The Association for Community Affiliated Plans has launched The ACAP Center for Social Determinants of Health Innovation. The center offers tailored resources, including policy reports, market research, and roundtable educational events, to help health plans, policymakers, and other stakeholders address social issues that impact health and wellbeing

Epic research suggests that like COVID-19, flu and other viral pneumonias can result in long-term symptoms like fatigue and brain fog. Why that might be is an open question.

A recent issue brief from the Kaiser Family Foundation says anxiety and depression, drug overdose deaths, self-harm and eating disorders have increased in adolescents as access and utilization of mental health care has declined.

FDA approves tumor-agnostic cancer therapy, Clovis pulls Rubraca indication, Purdue launches opioid reversal, FDA plans advisory committee meeting for Xphozah, and Manarini and AbbVie submit applications.

Certain problems such as pain/discomfort, worrying and fear of the persistence/recurrence of atopic dermatitis (AD) became more common among patients with AD since the start of the COVID-19 pandemic.

Respondents can win a $250 gift card.

Demand for birth control obtained through telehealth or without a prescription continues to grow, and some states have loosened up their rules. Meanwhile, groups and organizations involved in contraception are bracing themselves for the effects of the U.S. Supreme Court decision today overturned Roe v. Wade and the constitutional right to abortion.

The company will take no profit, which is part of the company’s bankruptcy filing and settlement with states.

In COVID-19 news, the FDA expanded emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 Vaccine for children down to 6 months of age. The FDA also approved Skyrizi for Crohn’s disease, Olumiant for alopecia, as well as two rare disease therapies: Imcivree for obesity associated BBS and Amvuttra for neuropathy associated with rare disease. Additionally, FDA extended the PDUFA date Brukinsa.

Walgreen’s patient insights and technology capabilities, along with partner healthcare companies, will aim to engage broader and more diverse communities for participation in clinical trials.

Technical and regulatory hurdles abound, but another challenge is finding enough providers who are comfortable and competent with artificial intelligence technology.

Genentech’s anti-amyloid crenezumab did not slow or prevent cognitive decline in people with early-onset Alzheimer’s disease.

The company also announced yesterday that will revive Wellpoint name in some markets.