PharmaFocus Today – Page 327 – media

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 ...
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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. ...
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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 ...
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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 ...
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- June 9, 2023
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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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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Merck sues US government over Medicare drug price negotiation programme

Merck & Co – known as MSD outside the US and Canada – has filed a lawsuit against the US government over the Medicare drug price negotiation element of President Biden’s Inflation Reduction Act (IRA). The IRA, which was enacted last year, allows Medicare – the government health plan for older adults – to negotiate lower prices for a selected group of prescription medicines. Merck argues that this violates the part of the Fifth Amendment to the US Constitution that requires the government to pay just compensation if it takes private property for public use. The lawsuit, filed in the US District Court for the District of Columbia, also argues that companies will be forced to sign agreements conceding that the prices are fair, which the drugmaker claims is a violation of the First Amendment’s protections of free speech. “These constitutional violations cannot be swept under the rug by pretending ...
- Source: drugdu
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GSK’s RSV vaccine approved by EC for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, makes Arexvy the first RSV vaccine for older adults to be granted European Marketing Authorisation. 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 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in Europe. GSK’s EU application was supported by positive results from its phase ...
- Source: drugdu
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Biosimilars ‘Fulfilling Their Promise’ of Lowering Biologic Prices

By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
- Source: drugdu
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