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Cancer drugs among top 5 most affected by shortages in the US

By Deidre McPhillips, CNN CNN — As the US faces a near-record number of drug shortages, cancer treatments are among the hardest hit. There is an active shortage of about two dozen chemotherapy drugs, the fifth most of any drug category, according to data from the end of March from the University of Utah Drug Information Service. “The fact that we have this many chemo drugs in shortage is really concerning,” said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists. Unlike some other drugs that also rank among the top five categories for shortages, such as antimicrobials, there aren’t often alternatives for chemotherapy drugs, he said. And the shortages are affecting treatment for a broad range of cancers. “One of the key predictors of how well a patient will respond to treatment is getting a full dose on the right schedule,” Ganio said. “So when ...
- Source: drugdu
- 111
- May 13, 2023
Capsule captures first look inside digestion in healthy people

Using a specially designed capsule, researchers can now voyage through the digestive system, collecting new data about digestion and microorganisms. The work by a team including researchers at the University of California, Davis, Stanford University and Envivo Bio Inc., is published May 10 in papers in Nature and Nature Metabolism. Most of the process of digestion takes place in our small intestine, where enzymes break down food so it can be absorbed through the gut wall. “The small intestine has so far only been accessible in sedated people who have fasted, and that’s not very helpful,” said Professor Oliver Fiehn, director of the West Coast Metabolomics Center at UC Davis. Metabolomics is the study of the metabolome, the small molecules involved in metabolism in cells, tissues and organs. Fiehn is senior author on the Nature Metabolism paper and co-corresponding author on the Nature paper. Jacob Folz, a postdoctoral researcher at UC Davis, is first author on the Nature ...
- Source: drugdu
- 144
- May 12, 2023
Experts call for monitoring of respiratory vaccine after trials suggest possible increase in preterm births

Experts have called for further scrutiny of a new Pfizer vaccine given during pregnancy to prevent respiratory infection in infants, after trials of a similar GSK vaccine were stopped after a rise in preterm birth and infant deaths. Pfizer says its vaccine is safe and effective, but experts contacted as part of an investigation published by The BMJ today, say Pfizer’s trial data should be reviewed in light of the signal for preterm births seen in GSK’s trial. Pfizer’s maternal RSV vaccine aims to protect infants from severe illness caused by the respiratory syncytial virus (RSV). RSV is very common but can be fatal, especially in young children. In 2019, an estimated 3.6% of all deaths worldwide in children aged 1–6 months were due to RSV, with 97% of these deaths occurring in low and middle income countries. The vaccine has not yet been approved for use, but a decision by the U.S. Food and Drug Administration is ...
- Source: drugdu
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- May 12, 2023
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
- 126
- May 12, 2023
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
- 121
- May 12, 2023
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
- 125
- May 12, 2023
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
- 126
- May 12, 2023
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 ...
- Source: drugdu
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- May 12, 2023
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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- May 12, 2023
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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- May 12, 2023

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