Morning Briefing
Summaries of health policy coverage from major news organizations
Most Americans Wouldn't Trust Their Health Provider's Use Of AI
The Hill: Majority In New Poll Would Be Uncomfortable With Health Care Provider Relying On AI
A majority of Americans in a new poll say they’d be uncomfortable with their health care provider relying on artificial intelligence (AI) as part of their medical care, and less than half think using AI would lead to better health outcomes. A Pew Research poll released Wednesday found just 39 percent of U.S. adults say they’d feel comfortable with AI as part of their medical care — in practices like screening, diagnosis and treatment — while 60 percent would feel uncomfortable. (Mueller, 2/22)
Stat: As FDA Bolsters AI Tool Regulation, Health Tech Industry Pushes Back
Health tech companies are in a tizzy: After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance. In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview. (Lawrence, 2/23)
On developments relating to treatments and therapies —
Reuters: CDC Panel Recommends Bavarian Nordic's Mpox Vaccine For All Adults At Risk
Advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Wednesday voted in favor of use of Bavarian Nordic's (BAVA.CO) Jynneos vaccine for all adults at risk of mpox during an outbreak. The panel of outside experts voted unanimously in favor of use of two doses of the vaccine, and finalizing the interim guidelines provided by CDC during the mpox outbreak in the United States. (2/22)
CIDRAP: FDA Begins Priority Review Of Pfizer RSV Vaccine For Maternal Use
Pfizer yesterday announced that the US Food and Drug Administration (FDA) has accepted it licensing application, which starts the review of its candidate respiratory syncytial virus (RSV) vaccine (RSVpreF) for use in pregnant women to help protect babies against the virus. In a press release, Pfizer said the FDA's review will be done on a priority basis and that the agency expects a decision in August. In December, the FDA granted priority review of the vaccine for use in older adults. (Schnirring, 2/22)
Reuters: Moderna's Combination Skin Cancer Therapy Receives FDA's Breakthrough Tag
Moderna Inc (MRNA.O) said on Wednesday its experimental personalised mRNA skin cancer vaccine in combination with Merck & Co Inc's (MRK.N) drug Keytruda has received breakthrough therapy designation from U.S. regulators as an additional treatment for high risk patients. (2/22)
Meanwhile, a new drug to combat HIV shows promise —
FiercePharma: GSK's Cabenuva Matches Gilead's Biktarvy In Head-To-Head Study
“We were so confident in Cabenuva. We’re certain that people, no matter what they were on, actually could derive a benefit from being on Cabenuva,” ViiV’s R&D head Kim Smith, M.D., said in an interview. In the SOLAR trial, five of 447 patients (about 1%) who switched from Biktarvy to Cabenuva had detectable HIV at or above 50 viral copies per milliliter of blood at 12 months. Among 223 patients who stayed on their original Biktarvy regimen, one (less than 1%) had detectable HIV. (Liu, 2/22)
Reuters: GSK's ViiV Says Study Shows Its Long-Acting HIV Shot As Effective As Gilead's Daily Pill
British drugmaker GSK's (GSK.L) HIV treatment division, ViiV Healthcare, published data on Wednesday showing its long-acting HIV injection is as effective as the market-leading daily pill made by Gilead Sciences Inc (GILD.O). GSK's ViiV ran the so-called "head to-head" clinical study on its own injection Cabenuva, which is given every two months, and Gilead's Biktarvy, an oral pill taken daily. (Fick, 2/22)
In other industry news —
FiercePharma: Lilly's Mounjaro Back In Stock Amid Heightened Obesity Interest
After an FDA approval last year, Eli Lilly’s diabetes drug Mounjaro has been on fire right out of the gate. Now, the Indianapolis pharma giant says it's resolved a months-long shortage. Lilly has satisfied wholesalers’ backorders for Mounjaro and is continuingly shipping all six doses of the diabetes med, a company spokesperson said. (Liu, 2/22)
The Wall Street Journal: Ozempic Runs Low For Diabetes Patients As Weight-Loss Use Surges
Diabetes patients said they are spending hours trying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs. (Loftus, 2/22)
FiercePharma: Gilead, Teva And J&J's HIV Antitrust Case Inches Closer To Trial
Gilead Sciences is no stranger to legal claims surrounding its market-leading HIV franchise. Now, the company and two other major biopharma players are heading to trial over claims they worked together to restrict competition in the marketplace. (Becker, 2/22)
The Boston Globe: Moderna To Partner With ElevateBio On CRISPR Research
Moderna is aiming to build a gene editing franchise powered by some of the same technologies used in its COVID-19 vaccines. The Cambridge biotech company announced Wednesday that it will partner with Life Edit Therapeutics to develop potentially permanent treatments for rare genetic diseases and other conditions. (Cross, 2/22)
AP: Amazon Closes $3.9B Buyout Of Health Company One Medical
Amazon said Wednesday it has closed its $3.9 billion acquisition of the primary care organization One Medical. The e-commerce giant has said the buyout, which was announced in July, is a key component of its growing health care business, which includes its online drugstore Amazon Pharmacy and a patient to doctor messaging service called Amazon Clinic. (Hadero, 2/22)
Politico: A Disappointing Report Card For Primary Care
The first report card on the state of the nation’s primary health care is out today, and it’s nothing to brag about. The report comes in response to a 2021 report by the National Academies of Sciences, Engineering, and Medicine, which called for a scorecard to be developed to monitor — and improve — America’s primary care. (Mahr and Payne, 2/22)
Modern Healthcare: Health System Payroll Expenses Jump Almost 10%
Payroll expenses at health systems nationwide increased by nearly 10% last year, highlighting continued issues with wage inflation and increased competition to recruit full-time employees. The number of healthcare workers slowly has been picking up, but the higher headcount only contributes in small part to the increased labor costs, according to healthcare consulting firm SullivanCotter. (Devereaux, 2/22)
