PharmaFocus Today – Page 351 – media

Simple Insulin Sensitivity Score Stratifies Post-CABG Risk

Marlene Busko, for Medscape May 10, 2023 The study covered in this summary was published on Research Square as a preprint and has not yet been peer reviewed. Key Takeaways People with a higher metabolic score for insulin resistance (METS-IR) had a significantly greater rate of major adverse cardiac events (MACE) after they underwent coronary artery bypass graft (CABG) surgery and independent of traditional cardiovascular risk factors in a Chinese study. Following CABG, patients in the highest quartile for METS-IR had a nearly twofold increased risk of MACE during follow-up compared with patients in the lowest METS-IR quartile after adjusting for potential confounders. Why This Matters CABG is standard treatment for people with multivessel and left main coronary artery disease and significantly improves cardiovascular outcomes, but long-term survival after CABG remains poor. This is the first reported study to examine the relationship between METS-IR and MACE in patients following CABG surgery. The results suggest that METS-IR is a simple and ...
- Source: drugdu
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Cell Phone Use Linked to Hypertension Risk?

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 ...
- Source: drugdu
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Perrigo’s OTC birth control pill aces FDA expert meeting

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 ...
- Source: drugdu
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Teva CEO Richard Francis, after 4 months at the helm, preps grand strategic reveal

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 ...
- Source: drugdu
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New drug delivery system delivers antioxidant directly to mitochondria in the liver

A new drug delivery system delivers an antioxidant directly to mitochondria in the liver, mitigating the effects of oxidative stress. Mitochondria are microscopic organelles found within cells, and are well-known as the “powerhouse of the cell.” They are by far the largest producer of the molecule adenosine triphosphate (ATP), which provides energy to many processes in living cells. The process by which mitochondria synthesize ATP generates a large amount of reactive oxygen species (ROS), chemical groups that are highly reactive. In a healthy cell, the ROS are controlled by the mitochondria; however, when this balance is lost, the excess ROS damages the mitochondria and subsequently cells and tissues. This phenomenon, known as oxidative stress, can cause premature aging and disease. The ROS that cause oxidative stress can be controlled by antioxidants. A research team led by Professor Yuma Yamada, Distinguished Professor Hideyoshi Harashima and Assistant Professor Mitsue Hibino at ...
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GSK’s RSV vaccine approved by FDA for older adults

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 ...
- Source: drugdu
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Understanding the adverse events profile of MVA-BN vaccine for Mpox

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 ...
- Source: drugdu
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AstraZeneca’s heart failure treatment approved for expanded use in US

AstraZeneca’s (AZ) Farixga (dapagliflozin) has been approved for extended use in the US, meaning adult patients with heart failure (HF) can benefit from the treatment regardless of their left ventricular ejection fraction status (LVEF). Farxiga, sold as Forxiga in certain markets, was previously approved in the US for HF patients with reduced ejection fraction (HFrEF) which is equal to or less than 40%. HF affects approximately seven million people in the US and is associated with substantial morbidity and mortality, with chronic HF the leading cause of hospitalisation for those over the age of 65. Roughly half of all HF patients have mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), with few therapeutic options available. As well as the greater risk of death and hospitalisations, patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations. The US Food and Drug Administration’s (FDA) ...
- Source: drugdu
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BMS, after last year’s West Coast purge, lays off 48 in New Jersey

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 ...
- Source: drugdu
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First Of Its Kind Urine Biomarker Methylation Test Predicts Bladder Cancer Recurrence

By LabMedica International staff writers Bladder EpiCheck is the first urine biomarker methylation test of its kind to be FDA cleared for NMIBC surveillance (Photo courtesy of Nucleix) Bladder cancer ranks as the sixth most common cancer in the U.S., with around 700,000 individuals living with the disease and over 80,000 new cases detected each year. The majority of these cases are classified as non-muscle invasive bladder cancer (NMIBC). Although NMIBC can be treated surgically and therapeutically, it has a high recurrence rate (up to 70% over five years), necessitating frequent monitoring to detect high-grade recurrence and treat it promptly. The standard of care involves regular and invasive cystoscopies, which patients undergo up to four times annually for a minimum of five years or, in some cases, for their entire lives. Now, a simple, objective urine test for recurrent bladder cancer is set to become commercially available in the ...
- Source: drugdu
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