The U.S. Food and Drug Administration’s independent panel of advisors Thursday recommended full approval of Pfizer’s vaccine that protects infants from respiratory syncytial virus, but raised safety concerns over premature births that may be tied to the shot. The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not. “If the vaccine actually lives up to the data we’ve seen today, I can guarantee many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, medical director at the Children’s Mercy Hospital in Kansas City, after voting in favor of the safety and efficacy of the shot. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.” “If ...
A new discovery about the structure of melanin has brought scientists one step closer to developing a new, potentially ultra-protective sunscreen derived from a biological substance found in nearly all organisms. Researchers from McGill’s Department of Chemistry, in collaboration with The Ohio State University and the University of Girona, have announced a major advance in understanding the fundamental structure of melanin and one of its components that turns light into heat, protecting the body from sun damage. Melanin, the pigment that gives humans their skin, eye, and hair colour, is the body’s first and best natural defense against the sun’s harmful rays. Cosmetics companies have long tried to harness the protective powers of natural and synthetic melanin for use in chemical sunscreens and other personal care products. For example, melanin could, in theory, be used to produce a radiation barrier that augments skin care products by matching a more diverse ...
Although employers are facing a difficult economic climate, nine in 10 said it will not lead to them reducing their investment in wellbeing programs for their employees, according to a new survey. Another three in 10 employers plan to increase their investment into wellbeing programs. The survey was published Wednesday by Fidelity Investments and Business Group on Health. It was conducted between December 2022 and January 2023 and received responses from 184 employers. Most of the employers have a global presence. Despite employers looking to maintain their wellbeing investments in the next three to five years, some areas of wellbeing will be emphasized more than others, the survey found. About 74% of respondents said they will expand mental health, 53% said they will expand financial wellness, 52% said they will expand work/life balance and 50% said they will expand physical health. Mental health, physical health and financial health are all ...
With scarce clinical resources unable to keep pace with elevated rates of mental illness, technological solutions could help decrease waitlists and disparities in access to therapy. Recent advances in artificial intelligence have fueled interest in the use of chatbots and virtual assistants for mental health treatment. A new study led by researchers from University of Illinois Chicago, with collaborators at Washington University and Pennsylvania State University, finds that an AI voice assistant app delivering a form of psychotherapy can help patients with mild depression and anxiety. The article, published in Translational Psychiatry, reports changes in brain activity along with improved depression and anxiety symptoms after using the AI voice assistant, called Lumen, for eight sessions of problem-solving therapy. The results of this pilot study, the first to test an AI voice-based virtual coach for behavioral therapy, offer encouraging evidence that virtual therapy can play a role in filling the gaps ...
A new study of more than 50,000 US adolescents across the country indicates that vaping nicotine is strongly linked with an increased likelihood of high levels use of binge drinking and cannabis usage. The findings, published today in Substance Use and Misuse, will add to growing public health concerns about the increased popularity of electronic cigarette (or “vaping”) use among young people. “While the overall health risks of vaping are lower than smoking, electronic cigarettes are still harmful to adolescents and warrant ongoing surveillance—especially as the long-term impacts remain unknown,” says lead author Noah Kreski from the Columbia University Mailman School of Public Health. “Our results indicate that vaping is not an isolated behavior, but rather strongly tied to other substance use that can harm adolescents and make quitting nicotine more difficult. Recognizing the strong overlap between various forms of substance use, effective intervention efforts should work to simultaneously address ...
The penguin-shaped Walnut Thermometer, intended for continuous chest temperature monitoring of children ages 6 and under, has been recalled due to reports of injuries, including skin burns. Amanda Pedersen | A popular children’s thermometer has been recalled after the manufacturer received reports of injuries such as skin burns. Hauppauge, NY-based BearCare initiated a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer. The wearable device is intended for continuous chest temperature monitoring of children up to age 6. The device has a silicone exterior designed to resemble a cartoon penguin. The thermometer was sold and distributed from December 2022 to April 2023 through Amazon, Walmart (online), and www.walnutcares.com. If users of the thermometer observe any substance leaking from the device’s exterior, any corrosion near the smart sensor on the back of the device, diminished battery life, or connectivity issues with the Walnut app, these are indicators of a failing device, ...
An industry-first FDA approval for a nonalcoholic steatohepatitis (NASH) therapy may still be a ways off.After reviewing Intercept Pharmaceuticals’ latest application for obeticholic acid (OCA), the agency appears all but ready to reject the drug in NASH-related pre-cirrhotic liver fibrosis, according to a briefing document released ahead of an expert panel meeting set for Friday. Citing a long list of safety risks and the practical hurdle for patients to undergo a liver biopsy—coupled with “modest” efficacy—the FDA said it “cannot justify OCA use in NASH subjects with stage 2 or 3 fibrosis.” The FDA’s negative review could once again thwart Intercept’s bid to win the first NASH approval in the U.S. If members of the FDA’s Gastrointestinal Drugs Advisory Committee side with the FDA and the agency follows through with its own staff’s analysis, it would mark the second rejection for OCA in NASH. Intercept’s stock price was down more ...
AbbVie’s aesthetics unit is growing its product catalog once again with a new FDA approval.The product, called Skinvive, nabbed an FDA nod this week and falls within Allergan’s Juvederm dermal filler collection. Skinvive works by injecting hyaluronic acid (HA), plus a small amount of lidocaine, into facial skin to increase hydration while smoothing. The delivery mechanism is the first of its kind and “flows easily into the skin,” creating a “lasting glow,” Allergan said in a recent release. Skinvive got the green light for use in adults over the age of 21 with all Fitzpatrick skin types I-VI covered, a skin classification scale that ranges from light to dark. Its effects last six months and the procedure requires little to no downtime, according to the company. The approval was supported by a pivotal clinical study in which 58% of patients saw their skin improve by more than one point on ...
Blue Cross Blue Shield of Massachusetts (BCBS Massachusetts) is expanding members’ access to primary care by adding Eden Health, On Belay Health Solutions and VillageMD to its network, the insurer announced Tuesday. New York City-based Eden Health offers primary care, telemedicine and insurance navigation. On Belay Health Solutions, based in Boston, works with independent primary care physicians and helps them engage in value-based contracts. Chicago-based VillageMD is a primary care provider that is majority owned by Walgreens Boots Alliance. These primary care physician groups will provide both virtual and in-person care for BCBS Massachusetts members. “Research shows that patients who have an established primary care physician achieve better health outcomes than those who don’t,” said Dr. Ashley Yeats, vice president of medication operations at BCBS Massachusetts. “These additional physician groups each offer a wide-range of services — including care navigation support, chronic disease care, mental health support — both in-person ...
Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS). The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo. MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.