Megan Brooks Using a mobile phone to make or receive calls for just 30 minutes a week is associated with an increased risk of developing hypertension, a large observational study using UK Biobank data suggests. The study showed adults who spent that at least a half-hour per week on their mobile phone had a 12% increased risk of developing hypertension, whereas those who spent more than 6 hours weekly had a 25% increased risk, compared with a weekly usage time of under 5 minutes. The investigators caution, however, that the results are purely “hypothesis-generating” and require confirmation, the researchers say. Experts not involved in the study also urged caution in interpreting the results. “This study should not be considered a basis to recommend reducing time spent using mobile phones to make calls as a technique to avoid hypertension,” Matthew Tomey, MD, cardiologist, Icahn School of Medicine at Mount Sinai in New ...
The jury has spoken, giving a unanimous “yes” to push Perrigo’s birth control tablet Opill over the counter. Wednesday, experts from a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter approval pivot. If approved later this year by the FDA, Opill would become the first OTC daily hormonal birth control pill cleared in the U.S. The unanimous vote came despite a number of big questions from the FDA about the potential for Opill’s responsible over-the-counter use in the real world. The FDA does not have to follow the advice of its advisory committees when making an approval vote, though it often does. Panelists had one main question to consider. Namely: Was there “adequate information to conclude that consumers will be likely to use [Opill] properly, such that the benefits of making this available for nonprescription use … exceed the risks.” Overall, panelists concluded ...
After a little over four months as Teva’s CEO, Richard Francis is getting ready to debut his long-term vision for the drugmaker. In Francis’ first quarter as Teva’s CEO, the Israeli pharma giant pulled down $3.7 billion in sales, a flat number versus the same period last year. In Europe, the company posted a 9% sales gain, Teva said Wednesday. Huntington’s disease and tardive dyskinesia med Austedo delivered a 10% global revenue gain to $170 million during the first quarter, while migraine prevention drug Ajovy posted a 35% increase to $95 million. Overall, first-quarter revenues came in around estimates, Barclays analysts wrote in a note to clients. In an investor presentation (PDF), Francis highlighted key attributes of the company, including its innovative pipeline and a “balanced risk portfolio.” The generics group is “a strong business that generates significant cash,” he added on Teva’s first-quarter earnings conference call. But what has ...
GSK’s respiratory syncytial virus (RSV) vaccine has been approved in the US for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 170,000 hospitalisations and approximately 14,000 deaths each year in the US. The company’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed ...
A recent study published in the Journal of American Medical Association (JAMA) evaluated adverse events following the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccination for mpox. Background Australia adopted a dose-sparing approach due to the shortage of MVA-BN vaccines in the recent mpox outbreak. Accordingly, a 0.1 ml intradermal dose was recommended for pre-exposure prophylaxis and a 0.5 ml subcutaneous dose for post-exposure prophylaxis in a two-dose regimen four weeks apart. The study and findings In the present study, researchers assessed adverse events following MVA-BN vaccination using data from AusVaxSafety, Australia’s vaccine safety surveillance system. Individuals vaccinated with MVA-BN from August 2022 to March 2023 at AusVaxSafety surveillance sites were asked to participate, which covered three-fourths of mpox vaccination sites. Participants received a survey link seven days after vaccination to complete a questionnaire on adverse events. Responses were considered for analysis if completed within seven days. Demographic details and vaccination ...
While smaller biotech outfits have certainly taken the brunt, the layoff deluge of the past year hasn’t spared big pharmas either. Now, after unveiling more than 250 job cuts in San Diego in September, Bristol Myers Squibb is turning its staff reduction campaign northeast. Starting at the end of May, BMS will roll out job cuts for 48 employees in Princeton, New Jersey, according to a new Worker Adjustment and Retraining Notification (WARN) alert filed with the state. The BMS site in question is a 650,000-square-foot facility that houses employees from the commercial team, plus commercialization and late-stage development partners from the R&D unit. The plant also hosts members of BMS’ global product development and supply teams, according to the company’s website. It’s not immediately clear what types of roles will be affected. Putting the cuts into context, Bristol’s business model is “evolving to support our mission to discover, develop and deliver innovative ...
It’s extremely unusual for the U.S. government to go after a pharmaceutical company for alleged patent infringement, much less take the case to trial. But in the government’s case against Gilead Sciences, the California drugmaker has come out on top.After years of litigation, Gilead prevailed following the trial in a Delaware federal court. The jury found the patents at issue were invalid, The New York Times reports.With that, the company doesn’t have to pay the more than $1 billion that the government sought with its patent infringement case. The company is “pleased” with the decision, Gilead’s executive vice president of corporate affairs and general counsel Deb Telman said in an emailed statement. “Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” Telman said. “Gilead will continue to champion collaborations, including our efforts with the ...
Most antidepressants used for chronic pain are being prescribed with “insufficient” evidence of their effectiveness, scientists have warned. A major investigation into medications used to manage long-term pain has found that harms of many of the commonly recommended drugs have not been well studied. Published in the Cochrane Database of Systematic Reviews, the study led by scientists from several UK universities including Southampton and Newcastle, examined 176 trials consisting of nearly 30,000 patients involved in assessments which prescribed antidepressants for chronic pain. Among the drugs studied were amitriptyline, fluoxetine, citalopram, paroxetine, sertraline, and duloxetine—with only the latter showing reliable evidence for pain relief. One third of people globally are living with chronic pain, World Health Organization data shows, with many prescribed antidepressants for relieving symptoms. Lead author Professor Tamar Pincus from the University of Southampton said, “This is a global public health concern. Chronic pain is a problem for millions ...
Lisette Hilton | Healthcare practices are already using chatbots to help with administrative tasks like scheduling appointments or requests for prescription refills. And while users say the current generative artificial intelligence (AI) technology falls short for safely treating patients, a recent survey of healthcare practices suggests 77% of users predict chatbots will be able to treat patients within the next decade. According to Software Advice’s 2023 Medical Chatbot Survey of 65 healthcare providers or practice owners who use live chatbots on their websites, which was conducted in March 2023, more than three quarters of those surveyed are extremely or somewhat confident in chatbots’ ability to assess patients’ symptoms. Chris R. Alabiad, MD, professor of clinical ophthalmology and ophthalmology residency program director at Bascom Palmer Eye Institute, Miami, FL, has tested the use of ChatGPT (Open AI) in the academic and clinical settings. He piloted the use of ChatGPT at Bascom ...
Spikevax, the COVID-19 vaccine from Moderna, has today been authorized for use in children aged 6 months to 5 years. The vaccine has been authorized in this new age group after it has been found to meet our standards of safety, quality and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence. This is the second COVID-19 vaccine to be authorized in this age group; the Pfizer/BioNTech vaccine (Comirnaty), was authorized in Great Britain for infants and children aged 6 months to 4 years on 6 December 2022. For this age group, the vaccine is given as a primary series of two 25-microgram injections in the upper arm or in the thigh, approximately one month apart. In reaching their decision, the MHRA’s experts carefully reviewed data from an ongoing clinical trial involving 6,388 children aged 6 months to ...
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