PharmaFocus Today – Page 368 – media

Pfizer puts kibosh on 4 antibiotics in India after contractor’s manufacturing issues

Global drug giant Pfizer is warning physicians and clinicians in India to immediately stop using four of its antibiotics due to manufacturing issues at a contract producer.The warning covers Magnex, Zosyn, Magnamycin and Magnex Forte. All four products treat infections, with Zosyn used to target various infections caused by bacteria including stomach infections, skin infections, pneumonia, and severe uterine infections. Magnamycin injections and Magnex Forte are also used to treat bacterial infections. The company issued the warning because of “deviations” at a manufacturing facility operated by Astral Steritech Private Limited, according to a letter shared on Twitter by Dr. Sudhir Kumar, M.D., of Apollo Hospitals in Hyderabad. “Whilst the manufacturer is currently investigating the matter, they have requested Pfizer, as an abundant precautionary measure and as per best practices, to temporarily suspend the sale/distribution/supply and use of the aforementioned products, pending the investigation by the manufacturer,” the company said in ...
- Source: drugdu
- 122
- May 20, 2023
FDA clears insertable cardiac monitor from Abbott

Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM). The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system. A small device with sensors inserted just under the skin of the chest, Assert-IQ provides constant, real-time monitoring. It can detect and identify arrhythmias that lead to symptoms like fainting, irregular pulse and shortness of breath. Abbott says many commercially available ICMs monitor hearts for “a few years,” but Assert-IQ offers two options. With a battery life of at least three or six years, it can provide doctors with a new level of flexibility in diagnostic monitoring. The three-year option offers a method for more traditional monitoring. That includes diagnosing fainting, heart palpitations or abnormal ...
- Source: drugdu
- 127
- May 20, 2023
CDC urges mpox vaccination among people at high risk to prevent summer surge

The Centers for Disease Control and Prevention on Thursday urged gay men and other individuals at high risk from mpox to get fully vaccinated to prevent a summer resurgence of the virus. The CDC’s call for those at risk to get up to date on their vaccines comes after a cluster of at least 21 mpox cases was reported in the Chicago area this month. Many of the people who caught mpox in the Chicago cluster were partially or fully vaccinated against the virus, raising questions about whether immunity from the shots might wane over time. The patients in the Chicago cluster all have mild symptoms, said Demetre Daskalakis, deputy head of the White House mpox task force, on a call with reporters Thursday. Daskalakis said no vaccine is perfect but people who have received two doses have a much lower risk of catching and spreading the disease. Vaccination also ...
- Source: drugdu
- 119
- May 20, 2023
FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

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 ...
- Source: drugdu
- 120
- May 20, 2023
Melanin structure discovery brings scientists one step closer to developing ultra-protective sunscreen

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 ...
- Source: drugdu
- 132
- May 20, 2023
Despite Economic Pressures, 90% of Employers Will Continue Wellbeing Programs, Survey Shows

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 ...
- Source: drugdu
- 122
- May 20, 2023
AI voice coach shows promise in psychotherapy for depression and anxiety

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 ...
- Source: drugdu
- 126
- May 19, 2023
New national study finds adolescent vapers much likelier to use cannabis and binge drink

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 ...
- Source: drugdu
- 125
- May 19, 2023
Intercept’s latest NASH bid in jeopardy after FDA questions drug’s efficacy, safety

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 ...
- Source: drugdu
- 151
- May 19, 2023
Wearable Children’s Thermometer May Cause Skin Burns

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, ...
- Source: drugdu
- 135
- May 19, 2023

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