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Analysis-GSK, Pfizer RSV Vaccine Sales Fall in US as Millions Fewer People Line Up
U.S. sales of RSV vaccines from GSK and Pfizer are down significantly after regulators narrowed the targeted age group and said it was a once-in-a-lifetime shot for now, excluding millions of people who got one last year.
Some independent pharmacists said demand during the autumn vaccination season for respiratory syncytial virus shots has fallen as much as two-thirds from a year ago.
So far, volumes reported by healthcare data company IQVIA and published in several Wall Street analyst notes roughly match that mark.
The shots are important for both Pfizer and GSK as they look to build new franchises before top-selling drugs face generic competition later this decade.
Pfizer is also contending with activist investor Starboard Value and weakening demand for its COVID-19 products that has led to a stock price decline by around half from its pandemic highs.
It also forced the New York-based drugmaker to announce two separate cost cut plans for over $5.5 billion.
Should I Prescribe Liraglutide to a 6-Year-Old Patient With Obesity if FDA Approved?
Muth is a primary care pediatrician and obesity medicine specialist.
As a pediatric obesity medicine specialist, I have witnessed first-hand the benefits of GLP-1 receptor agonists in the treatment of adolescent obesity.
In particular, semaglutide (Wegovy) plus intensive health behavior lifestyle treatment has improved comorbid health risk factors, physical activity tolerance, sleep, body image, and self-confidence in many of the adolescents that I care for at a primary care-based clinic.
But for the many younger children (under 12 years old) I see, no matter how severe the obesity or significant the obesity-related risk factors — like prediabetes, fatty liver, hypercholesterolemia, sleep apnea, or bullying and psychosocial distress — no medication options are approved to accompany intensive health behavior lifestyle intervention.
That may all change soon.
The U.S. Food and Drug Administration is currently considering approval of liraglutide for the treatment of severe obesity in children ages 6-12.
The review comes on the heels of a randomized trial published in the New England Journal of Medicine, or NEJM demonstrating the safety and efficacy of liraglutide, added to lifestyle intervention, in treating severe obesity in this patient population.
FDA Authorizes Sale of First Home COVID/Flu Combo Test Outside of Emergency Use
As the country heads into the respiratory illness season, the US Food and Drug Administration (FDA) announced yesterday its marketing authorization of the first over-the-counter (OTC) rapid-antigen COVID-19/flu combination test outside of emergency use authorization.
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test takes 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs.
It joins other OTC COVID-19/flu tests already available under emergency use authorization.
The test is designed for use by people aged 14 years or older collecting and testing their own sample or those two and older with adult assistance.
FDA review of data from people with signs and symptoms of COVID-19 and flu showed that the test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative flu A and B samples, and 92.5% and 90.5% of positive influenza A and B samples, respectively.
The FDA and the National Institutes of Health’s Independent Test Assessment Program collected the validation data.
GSK Says RSV Vaccine Protects Against Disease Over Three Seasons
Vaccine maker GSK unveiled new data Tuesday showing its respiratory syncytial virus vaccine Arexvy protected older adults over three seasons against disease caused by infection.
Across the entire time period, one dose of Arexvy was 63% effective against RSV broadly, and 67% effective against severe disease, GSK said.
However, the shot’s efficacy waned, falling to an estimated 48% in the third season alone.
Currently, the Centers for Disease Control and Prevention doesn’t recommend a second RSV vaccine dose.
While GSK described the three-season data as evidence of the shot’s “significant health impact,” it said that “over time, revaccination is expected to be required to maintain an optimal level of protection.”
Acne Treatments Taken Right off the Shelf Had High Levels of Benzene
Dozens of over-the-counter acne products had very high levels of the known carcinogen benzene, even when they were taken right off the store shelves, researchers found.
Among 111 benzoyl peroxide (BPO) products purchased from various retailers across the U.S., about a third (34%) had benzene above the “conditionally restricted” U.S. Food and Drug Administration limit of 2 ppm, reported Kaury Kucera, PhD, of Valisure, an independent laboratory in New Haven, Connecticut, and colleagues.
Concentrations ranged widely — from 0.16 ppm to 35.3 ppm — and studies have shown there’s “no safe level of exposure to benzene,” they noted in the Journal of Investigative Dermatology.
Researcher Finds Bias in Funding of Trials by Drug Manufacturers
Psychiatric drugs are reported to be about 50% more effective in clinical trials funded by the drug’s manufacturer than when trials of the same drug are sponsored by other groups, new research shows.
While many studies have found more favorable results for drugs in clinical trials funded by their manufacturers, these studies normally just compare a set of manufacturer-funded studies with a set of studies funded in other ways, said Tamar Oostrom, assistant professor of economics at The Ohio State University, who conducted this new research.
This new study, now published in the Journal of Political Economy, is the first to have an apples-to-apples comparison.
“I compared different clinical trials in which the exact same pairs of drugs are compared for their effectiveness — the only substantial difference being who funded the study,” Oostrom said.
Oostrom called her finding the “sponsorship effect.”
Hormonal Contraception Linked to Increased Breast Cancer Risk in BRCA1 Carriers
Carriers of the BRCA1 cancer gene had a significantly increased risk of breast cancer if they used hormonal contraception (HC), pooled cohort data showed.
Breast cancer risk increased by 29% in BRCA1 carriers who reported any use of HC during at least one 12-month continuous period.
The risk also increased with duration of HC use, but separate analyses showed no increased risk associated with current use within the past year, 1-5 years in the past, 6-10 years before, or more than 10 years.
The analysis showed no evidence of increased breast cancer risk for BRCA2 carriers who used HC, reported Kelly-Anne Phillips, MD, MBBS, of Peter MacCallum Cancer Center in Melbourne, Australia, and co-authors in the Journal of Clinical Oncology
CDC Will Test Travelers From Rwanda for Ebola-Like Marburg Virus
As health officials work furiously to stem the spread of Marburg virus in Rwanda, U.S. health officials announced Monday that all passengers flying from that country to the U.S. will soon be screened for the often deadly disease.
“Starting the week of Oct. 14, U.S. Centers for Disease Control and Prevention (CDC) will begin public health entry screening of travelers entering the U.S. who have been in Rwanda in the past 21 days,” the U.S. Department of Health and Human Services said in a statement.
“This screening aims to reduce the risk of importation of Marburg cases into the United States and the spread within U.S. communities.”
As of Monday, 56 cases of Marburg had been confirmed in Rwanda, with 36 people in isolation and treatment, and 12 deaths, according to that country’s Ministry of Health.
No cases of Marburg virus have been reported in the U.S. at this point.
Travelers coming from Rwanda will be routed to one of three airports: Chicago O’Hare, JFK in New York and Washington Dulles in Virginia, the CDC said in a statement Monday, NBC News reported.
