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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

HHS released a new proposed rule to update nearly 50-year old regulations protecting people with disabilities from discrimination while seeking healthcare. With its new proposal, HHS is amending the regulations to be clearer in their language, as well as more aligned with the Americans with Disabilities Act, the Americans with Disabilities Amendments Act and amendments to the Rehabilitation Act.

Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs that were selected for the program — its heart failure medication Entresto was one on the list. HHS can expect to face more lawsuits from the manufacturers of the 10 drugs it named last week, experts have warned.

Amgen and the Federal Trade Commission are settling the lawsuit the regulator filed to block the pharmaceutical giant’s $28 billion Horizon Therapeutics acquisition. As part of the settlement, Amgen agrees not to “bundle” its products with Horizon’s drugs in negotiations with health plans.

Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.

California passed a law last year aimed at controlling rising healthcare costs that gave the state the ability to scrutinize healthcare deals of a certain size involving California companies. What impact can it have?

HHS released the first 10 drugs selected for the Medicare Drug Price Negotiation Program. These drugs include Eliquis, Jardiance and Xarelto. Under the program, the federal government will be able to negotiate the price for selected drugs for the first time.

Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.

As the debate over worker misclassification rages, it’s important that healthcare professionals know the facts. Staffing agencies that designate their nurses as independent contractors avoid the costs of employment-related benefits like insurance, workers’ compensation, and overtime pay. These agencies also lack necessary clinical and professional oversight over their contractors, which increases the risk of substandard care.

In a new lawsuit, Bon Secours Mercy Health Virginia alleges that Anthem Health Plans of Virginia owes the health system more than $93 million in outstanding unpaid and underpaid claims.

Pediatricians and anyone who works with children should proactively reach out to their patients with resources and information about how to maintain coverage. Ask them to make sure their contact information is updated in state databases. Tell them to expect and respond to any communication from the state about their enrollment status.

Two Florida families allege that tens of thousands of Floridians are being terminated from Medicaid coverage without sufficient information as to why. This comes as the U.S. continues the unwinding of the Medicaid continuous enrollment requirement, which stopped states from disenrolling Medicaid enrollees during the Covid-19 public health emergency.

Generic drugmakers Teva and Glenmark recently became the sixth and seventh drugmakers to resolve criminal charges as a result of the DOJ’s yearslong investigation into generic drug price fixing. The settlement agreement requires both companies to pay hefty fines as well as divest their drug lines for pravastatin, a widely used statin that lowers cholesterol.

U.S. Representative Frank Pallone, Jr. (D-New Jersey) announced that he is looking into high prior authorization denial rates by Medicaid managed care health plans. It follows a report by the Office of Inspector General that found that Medicaid MCOs denied one out of every eight prior authorization requests in 2019.

Santa Clara Valley Healthcare in California has begun notifying 43,000 patients about their eligibility for billing corrections and refunds. The system’s patient outreach effort is a result of a recently settled lawsuit filed against Santa Clara County. In the complaint, former patients alleged the county did not inform them about its hospitals’ charity care and discount payment policies, leading them to have to pay large bills.

Oncology is already a big piece of Pfizer’s drug lineup. The portfolio is expanding to multiple myeloma with FDA approval of Elrexfio, a bispecific antibody that targets the cancer protein BCMA.