PharmaFocus Today – Page 370 – media

Scientists find mutations, say threat is still low

A man in Chile is infected with a bird flu that has concerning mutations, but the threat to people from the virus remains low, U.S. health officials said Friday. Past animal studies suggest these mutations could cause the virus to be more harmful or spread more easily, health officials said. But they also said there is no evidence that the mutations would make it easier for it to take root in a person’s upper lungs—a development that would raise concerns about spread among people. The mutations do not change public health officials’ assessment of the overall risk to people from the H5N1 virus, which “continues to be low,” said Vivien Dugan of the Centers for Disease Control and Prevention. The mutations, which have appeared only in the one hospitalized patient, may have occurred after the man got sick, CDC officials said. There’s no evidence that the mutated virus spread to other people, mixed with ...
- Source: drugdu
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- April 17, 2023
Adding new vaccine type to leading immunotherapy dramatically reduced melanoma recurrence

The combination of an experimental mRNA vaccine with an immunotherapy reduced the likelihood of melanoma recurring or causing death by 44% when compared to immunotherapy alone, a new clinical trial shows. Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the randomized phase 2b trial involved men and women who had surgery to remove melanoma from lymph nodes or other organs and were at high risk of the disease returning in sites distant from the original cancer. Among 107 study subjects who were injected with both the experimental vaccine, called mRNA-4157/V940, and the immunotherapy pembrolizumab, the cancer returned in 24 subjects (22.4%) within two years of follow-up, compared with 20 out of 50 (40%) who received only pembrolizumab. “Our phase 2b study shows that a neoantigen mRNA vaccine, when used in combination with pembrolizumab, resulted in prolonged time without recurrence or death compared with pembrolizumab alone,” said study senior investigator ...
- Source: drugdu
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- April 17, 2023
FDA again knocks back Alvotech’s Humira biosimilar

The copycat version of AbbVie’s blockbuster still has court clearance to launch on July 1, but only if regulators have approved it. For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday. The agency’s decision comes less than three months before Alvotech is free to launch the drug in the U.S. under a settlement with AbbVie, Humira’s manufacturer. Alvotech has a second FDA application pending that, if approved by June 28, would make it one of the first “interchangeable” Humira biosimilars, meaning pharmacists could directly substitute it for the branded product. An expected launch on July 1 could be delayed if the FDA doesn’t grant the main approval, which would clear the biosimilar for sale in the U.S. In a statement Thursday evening, Alvotech said it provided ...
- Source: drugdu
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- April 17, 2023
Caris Life Sciences and Flare to collaborate for oncology pipeline advancement

Caris Life Sciences and Flare Therapeutics have announced a partnership to advance the precision oncology pipeline of the latter into clinical trials. The multi-year strategic partnership will leverage latest molecular profiling approaches guiding patient selection and participation to accelerate precision medicine approaches across five of the therapeutic programmes of Flare. It will use the comprehensive molecular tissue and liquid profiling services of Caris including whole transcriptome sequencing and whole exome sequencing for participants in Flare’s clinical trials. Additionally, the partnership will apply Caris’ data and analytics tools to strengthen future enrolment programme for trials and companion diagnostics capabilities. Flare Therapeutics chief development officer Michaela Bowden said: “We understand the importance of shaping translational insights early on as a major area of focus to help ensure efficient drug development at scale and clinical trial preparedness. “With access to Caris’ robust clinico-genomic real-world data, comprehensive molecular profiling and ...
- Source: drugdu
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- April 17, 2023
The policy, and politics, of Medicare Advantage

Medicare Advantage, the private-sector alternative to original Medicare, now enrolls nearly half of all Medicare beneficiaries. But it remains controversial because — while most of its subscribers like the extra benefits many plans provide — the program frequently costs the federal government more than if those seniors remained in the fully public program. That controversy is becoming political, as the Biden administration tries to rein in some of those payments without being accused of “cutting” Medicare. Meanwhile, President Joe Biden has signed a bill to declassify U.S. intelligence about the possible origin of covid-19 in China. And new evidence has emerged potentially linking the virus to raccoon dogs at an animal market in Wuhan, where the virus reportedly first took hold. Among the takeaways from this week’s episode: The Biden administration recently changed the formula used to calculate how much the federal government pays private Medicare Advantage ...
- Source: drugdu
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- April 17, 2023
Higher Paxlovid uptake in winter 2022 could have prevented nearly 5,000 deaths

In a recent study published in the JAMA Health Forum, researchers in the United States estimated the reduction in coronavirus disease 2019 (COVID-19) mortality rates after the Paxlovid rollout. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections were the third largest cause of mortality in the United States in 2022, and after the Food and Drug Administration (FDA) approved Paxlovid (nirmatrelvir and ritonavir), the test-to-treat strategy became a pillar of the US pandemic response. Treatment with Paxlovid necessitates testing and medication initiation within five days after COVID-19 symptoms start. However, the population-level effect of the Paxlovid rollout has not been evaluated. About the study In the present study, researchers estimated the simulated influence of the Paxlovid rollout on COVID-19-related hospitalizations and deaths. The team modeled COVID-19-related hospitalization and death rate reductions after Paxlovid introduction as the product of (1) the number of symptomatic patients diagnosed within five ...
- Source: drugdu
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- April 17, 2023
Pregnant women show unique immune response to COVID-19

Infection with the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), which is the causal agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, has claimed more than 6.8 million lives worldwide. It remains imperative to understand the immune responses to SARS-CoV-2, particularly in high-risk groups, to formulate better vaccination and treatment strategies. The immune response to COVID-19 during pregnancy Immunological assessment related to COVID-19 has been performed largely in healthy individuals across varied age groups. After contracting SARS-CoV-2 infection, patients typically develop robust and transient immune responses that include an abundance of SARS-CoV-2-specific antibodies, T-cells, B-cells, and long-lasting immune memory. Severe SARS-CoV-2 infection has been characterized by the presence of blood hypercytokinemia and hyperactivation of innate/adaptive immune responses. Limited studies have been performed on the immune response after SARS-CoV-2 infection in pregnant women. Pregnant women are considered to be highly susceptible to COVID-19 due to immunological and physiological changes ...
- Source: drugdu
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- April 17, 2023
To protect kids from tobacco, pediatricians say, focus should be on quitting – or never starting

Although smoking rates for adults in the US are at their lowest recorded levels, more must be done to stop children from using tobacco, according to a new set of policy statements from the American Academy of Pediatrics. The statements, published Monday, are the association’s first tobacco policy update since 2015. They’re based on newer science and better reflect how many children now use e-cigarettes as more kid-friendly products have flooded the market. AAP policy statements are created by expert pediatricians to help leaders craft more effective public health policy and to guide physicians on how to keep kids safe – in this case, from tobacco. High rates of tobacco use Researchers have been telling Americans for generations that tobacco products are bad for them, yet nearly 200 US children take up smoking every day, according to the US Centers for Disease Control and Prevention. Tobacco ...
- Source: drugdu
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How a virus causes chromosomal breakage, leading to cancer

The Epstein-Barr virus (EBV) is easily spread through bodily fluids, primarily saliva, such as kissing, shared drinks or using the same eating utensils. Not surprisingly then, EBV is also among the most ubiquitous of viruses: More than 90% of the world’s population has been infected, usually during childhood. EBV causes infectious mononucleosis and similar ailments, though often there are no symptoms. Most infections are mild and pass, but the virus persists in the body, becoming latent or inactive, sometimes reactivating. Long-term latent infections are associated with several chronic inflammatory conditions and multiple cancers. In a new paper, published April 12, 2023 in the journal Nature, researchers at University of California San Diego, UC San Diego Moores Cancer Center and Ludwig Cancer Research at UC San Diego, describe for the first time how the virus exploits genomic weaknesses to cause cancer while reducing the body’s ability to suppress it. These findings show ...
- Source: drugdu
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- April 14, 2023
Study unveils neural processes underpinning the re-emergence of consciousness after anesthesia

Before undergoing surgeries and other invasive medical procedures, patients typically undergo anesthesia. Anesthesia consists in giving patients a class of drugs (i.e., anesthetics) that cause them to lose feeling in specific areas of the body (i.e., local anesthesia) or fully lose awareness during a procedure (i.e., general anesthesia). These anesthetics can be administered to patients via injection, inhalation, skin-numbing lotions, and other means. In the past, doctors and medical researchers viewed general anesthesia as a passive process that could not be influenced or interrupted once anesthetic drugs were administered. More recently, however, studies showed that it is in fact an active brain process that can be experimentally controlled and acted on. A research team at the Southern University of Science and Technology in China recently carried out a study investigating the processes underpinning brain states while under general anesthesia and those associated with the subsequent re-emergence of awareness. Their findings, published in Nature Neuroscience, highlight possible strategies that could help anesthesiologists to extend ...
- Source: drugdu
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- April 14, 2023

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