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New devices could help Penumbra take market share, according to physician survey

Dive Brief Penumbra is expected to retain and take market share in the peripheral vascular market over the next 6 to 18 months, according to a survey of physicians by J.P. Morgan analysts. The firm surveyed 25 vascular surgeons, who forecast that Penumbra will take share as the broader peripheral market is expected to grow. “New products should drive share capture across both arterial and venous,” J.P. Morgan analyst Robbie Marcus wrote in a Thursday research note, although the majority of doctors surveyed expect to continue using devices from multiple manufacturers even when targeting the same vessels. Dive Insight Alameda, Calif.-based Penumbra recently launched two new thrombectomy devices: Lightning Bolt 7, which is designed to remove clots from the arteries, and Lightning Flash, which is designed for the veins and pulmonary arteries. The surgeons’ reception to both devices was “broadly positive,” Marcus wrote, with the majority saying they expected Lightning ...
- Source: drugdu
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- June 10, 2023
Study may help advance data on oncolytic adenovirus mediated double suicide-gene therapy for high-grade brain tumors

Researchers in the Hermelin Brain Tumor Center at Henry Ford Health are leading a Phase I clinical trial studying the maximum tolerated dose of an oncolytic adenovirus, a mutated virus engineered to selectively replicate in and destroy cancer tissue, in combination with fractionated stereotactic radiosurgery among patients who are undergoing resection of a recurrent high-grade astrocytoma brain tumor. Tobias Walbert (M.D., Ph.D., principal investigator of the study and co-director of the Hermelin Brain Tumor Center at Henry Ford Health) said, “The participants in this study have progressive high-grade astrocytoma as well as glioblastoma, and are scheduled to undergo repeat surgery. After the removal of as much tumor tissue as possible, a modified oncolytic adenovirus is injected into the wall of the resection cavity and any residual tumor tissue. The goal of this study is to determine the maximum tolerated dose of the injected adenovirus, which is engineered to selectively replicate ...
- Source: drugdu
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- June 10, 2023
FDA Indicates Potential Full Approval for Eisai & Biogen’s Leqembi Ahead of Adcomm

By Rosemary Scott Pictured: Three side-by-side scans of a human brain/iStock, semnic The FDA released briefing documents Wednesday that signal it is likely to grant Eisai and Biogen’s Leqembi (lecanemab) full approval to treat Alzheimer’s disease on its decision date in July. The documents come just two days before an advisory committee is scheduled to vote on whether to recommend the drug’s approval. The FDA has asked the six members of the advisory committee to answer the following question: Do the results of a pivotal trial dubbed Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? But it appears the agency may have already decided for itself. Both the briefing documents and the committee’s decision will be based on the Study 301results. In the documents, the FDA stated that the data from the trial showed “consistently favorable results for the primary and secondary endpoints,” ...
- Source: drugdu
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FDA advisers endorse antibody to protect against RSV in infants and some young toddlers

By Jamie Gumbrecht, CNN CNN — Advisers to the US Food and Drug Administration voted Thursday to endorse a monoclonal antibody designed to protect infants and some young toddlers from RSV. Members of the agency’s Antimicrobial Drugs Advisory Committee voted 21-0 that the benefit-risk profile of nirsevimab was favorable in infants and 19-2 that it was favorable in children up to 24 months who are vulnerable to severe respiratory syncytial virus. Next, the FDA will consider the advice of the advisers and decide whether to approve the treatment. The monoclonal antibody, nirsevimab, was developed by AstraZeneca and Sanofi. It’s designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable. If approved, it will be the first single-dose preventative treatment for all ...
- Source: drugdu
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Neurotic people are more likely to suffer from mood swings, study finds

In everyday life, our emotions often change from moment to moment, and people experience these fluctuations to varying degrees. Psychologists at Leipzig University have studied the relationship between the personality trait neuroticism—a potential risk factor for mental health—and emotional experiences. They found that neurotic people experience negative emotions not only more intensely, but also with more mood swings than others. They have just published their findings in the Proceedings of the National Academy of Sciences (PNAS). “Previous studies are in agreement that neurotic people experience stronger negative emotions in everyday life. Because of new, contradictory studies, there has been disagreement about whether this is also associated with increased variability in emotional experiences, i.e., mood swings,” says the study’s first author, Nina Mader from the Wilhelm Wundt Institute of Psychology at Leipzig University. Personality psychologists at Leipzig University have developed a new approach to modeling data that solves previous methodological problems. ...
- Source: drugdu
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- June 9, 2023
New study shows certain blood pressure drugs could boost the efficacy of cancer immunotherapy

A Ludwig Cancer Research study has shown that some molecules previously used to treat hypertension might also help the immune system to better target cancer cells. Reported in the current issue of Nature, these findings could, in time, be applied to significantly improve the effectiveness and applicability of cancer immunotherapy. “Immunotherapy today can effectively fight only 30% to 40% of cancers,” said Benoît Van den Eynde, who is a member of the Ludwig Institute for Cancer Research, co-director of the de Duve Institute and professor of Tumor Immunology at the University of Oxford. “Many cancers are resistant, largely because their T lymphocytes are not reactive enough. We discovered that drugs once used to treat hypertension could have a very interesting effect in combating these forms of immunotherapy-resistant cancers.” The immune system protects against disease by destroying foreign substances and pathogens, such as bacteria and viruses. T lymphocytes, a type of ...
- Source: drugdu
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Study

The expected course of a patient’s cancer prognosis has traditionally been judged by its type, stage and microscopic aggressiveness, but patients with the same presentation can still have widely divergent outcomes. Researchers from Vanderbilt-Ingram Cancer Center have discovered that differences in tumor mutation burden are a major reason for this divergence. The study, published in JCO Precision Oncology, has revealed that mutation burden is a fundamental predictor of survival, independent of the clinical presentation metrics currently used. The researchers state in the study that mutational indices can be “used to predict disease course as effectively as (cancer) stage or grade.” William Dupont (Study Corresponding Author and Professor, Biostatistics, Health Policy, and Preventive Medicine, Vanderbilt University Medical Center) said, “A major insight of the study was the observation that survival was better at both low and high extremes of tumor mutation burden.” The study investigated the Pan-Cancer Atlas of 10,652 patents ...
- Source: drugdu
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Philips faces new recall of Evo respirators, tagged Class I by FDA

Dive Brief As many as 57,000 Evo ventilators are facing a voluntary recall by Philips over problems with the machines’ air flow sensor. The U.S. Food and Drug Administration has labeled the recall Class I, warning that filters must be changed regularly to prevent debris accumulating on sensors and impeding air flow. The recall is the second for the Evo ventilator in recent months, and follows the recall of more than 5 million CPAP, BiPAP and other breathing assistance devices made by Philips. Dive Insight Philips’ Respironics unit has faced multiple recalls since it first flagged problems with soundproofing foam used in several of its sleep apnea devices and ventilators in 2021. The Evo ventilator used in hospital and professional care settings is facing its second Class I recall in recent months. The Dutch device maker issued the recall on May 1, instructing users to change filters more frequently to ...
- Source: drugdu
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FDA document outlines apparent agency support for full approval of Biogen, Eisai’s Leqembi

As Alzheimer’s disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.In advance of a highly anticipated FDA advisory committee set for Friday, the agency released a briefing document that appears to support a full FDA approval for Leqembi. On efficacy, the agency said the drug’s treatment effect in its pivotal trial, called Study 301, is “supported by the consistently favorable results for the primary and secondary endpoints across the prespecified subgroups of interest.” In the study, investigators tested Leqembi against placebo in patients with mild cognitive impairment due to Alzheimer’s or mild Alzheimer’s dementia. The study measured the drug’s efficacy on an endpoint called the Clinical Dementia Rating-Sum of Boxes at 18 months of treatment. On ...
- Source: drugdu
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- June 9, 2023
Johnson & Johnson, Legend file for expanded use of Carvykti after key trial win

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy. After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid. With such an approval, Carvytki could leapfrog BMS’ multiple ...
- Source: drugdu
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- June 9, 2023

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