The age of those who are distressed because of a mismatch between their biological sex and their gender identity—known as gender dysphoria—has been steadily falling, reveals research published in the open access journal General Psychiatry. And it’s lower for those assigned female sex at birth than those assigned male, the findings indicate. Recent studies suggest that gender dysphoria is becoming more common, particularly among those assigned female sex at birth. But these studies have been hampered by small sample sizes, short monitoring periods, or outdated datasets. In a bid to get round these limitations, the researchers drew on data submitted to the TriNetX database Research Network from 49 health care organizations between 30 April 2017 and 30 April 2022 inclusive. This database holds the anonymized medical records of around 66 million people, most of whom (80%) live in the U.S.. The researchers focused on 42 million 4 to 65-year-olds, 66,078 ...
Dive Brief More than 1.31 billion people worldwide could be living with diabetes by 2050, according to estimates published in the Lancet. In 2021, roughly 529 million people worldwide had diabetes, according to the International Diabetes Federation. The rise in prevalence is expected to be driven by increases in Type 2 diabetes. Overall healthcare spending related to diabetes is expected to rise to $1.054 trillion by 2045, the authors wrote. Global spending in 2021 was estimated at $966 billion by the International Diabetes Federation. Dive Insight With diabetes cases expected to increase globally, current treatment is focused on biomedical interventions and new devices, according to an editorial published in the Lancet that accompanied the researchers’ findings. The authors said people who are marginalized and discriminated against suffer the “most and worst consequences” of diabetes, and “addressing structural racism must become a core component of preventive strategies and health promotion — ...
By monitoring early-response biomarkers in men undergoing 177Lu-PSMA prostate cancer treatment, physicians can personalize dosing intervals, significantly improving patient outcomes. In a study presented at the Society of Nuclear Medicine and Molecular Imaging 2023 Annual Meeting, early stratification with 177Lu-SPECT/CT allowed men responding to treatment to take a “treatment holiday” and allowed those not responding the option to switch to another treatment. Approved by the U.S. Food and Drug Administration in 2022, 177Lu-PSMA is an effective treatment for metastatic castration-resistant prostate cancer. However, not all men respond equally to treatment, with some responding very well and others progressing early. “Currently, a standardized dosing interval is used for 177Lu-PSMA treatment,” said Andrew Nguyen, MBBS, FRACP, AANMS, senior staff specialist in the Department of Theranostics and Nuclear Medicine at St. Vincent’s Hospital in Sydney, Australia. “However, monitoring early-response biomarkers to adjust treatment intervals may improve patient outcomes.” In the study, researchers sought ...
Pfizer has terminated one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates as the race heats up to market the first oral weight loss drug. The loss of lotiglipron means Pfizer will rest its hopes on its other candidate danuglipron to take on Novo Nordisk and Eli Lilly for the first marketed weight loss pill. The market responded accordingly to Pfizer’s announcement about shelving the program, with shares in the company opening 3% lower on Monday morning compared to pre-announcement market close (23 June). The decision to scrap lotiglipron was due to elevated levels of transaminases seen in two Phase I studies and a currently ongoing Phase II study. Pfizer said no liver-related symptoms or side effects were observed and added that the increase in transaminase levels has not been seen in any of its danuglipron trials. Pfizer has already published results for danuglipron in the Journal of the American ...
More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.Jazz is challenging the regulator for approving Avadel Pharmaceuticals’ narcolepsy drug Lumryz, which poses a major threat to Jazz’s blockbuster Xyrem/Xywav franchise. In U.S. district court in Washington, D.C., Jazz claimed that the green light for Lumryz—which was awarded on May 1—was “unlawful.” The Dublin company says that the approval violated the orphan drug exclusivity (ODE) the agency granted to Xywav in 2021. In awarding Lumryz its own ODE, the FDA ruled that Lumryz is superior to Jazz’s offerings, citing its ability to make a major contribution to patient care based on its convenience and additional clinical benefit. While Lumryz is taken once a night, Xywav requires two doses. Both are oral suspension drugs. Jazz maintains that the FDA acted ...
Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval. David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018″. He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”. Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the ...
Two Republican 2024 presidential hopefuls talked up their opposition to abortion on Sunday on the one-year anniversary of the Supreme Court’s decision in Dobbs v. Jackson, the decision that overturned Roe v. Wade. Presidential candidate and former Vice President Mike Pence described last year’s landmark decision as “a historic victory” that condemned Roe v. Wade to “the ash heap of history.” Pence earlier this week called for all GOP candidates to commit to a nationwide ban on abortion after 15 weeks — but he said on Sunday that it was also important to “stand with compassion.” “With 62 million unborn lives lost, and just about as many women who have endured the two generations under abortion, I think we need to bring a message of grace, we need to bring a message of kindness,” Pence said in an interview on “Fox News Sunday.” “That’s how we’re going to win hearts ...
By Tarun Sai Lomte Reviewed by Lily Ramsey, LLM A recent Morbidity and Mortality Weekly Report described the progress toward eliminating rubella in the South-East Asia region (SEAR) of the World Health Organization (WHO). In 2013, SEAR countries adopted goals to eliminate measles and control congenital rubella syndrome (CRS) and rubella by 2020. In 2019, these countries announced plans to eliminate rubella and measles by 2023. The authors discussed the progress in rubella elimination in the SEAR between 2013 and 2021 in the present study. Study: Progress Toward Rubella Elimination — World Health Organization South-East Asia Region, 2013–2021. Image Credit: NovikovAleksey/Shutterstock.com Vaccination programs for Rubella The rubella-containing vaccine (RCV) was only available in Bhutan, Maldives, Bangladesh, Thailand, and Sri Lanka before 2013; other SEAR countries introduced the vaccine during 2013-21. Of these, only three countries offered the second dose before 2013; the remaining offered the second between 2013 and 2021. The ...
By Elaine Chen STAT – Reporting from the frontiers of health and medicine Liver illustration HYACINTH EMPINADO/STAT SAN DIEGO — The American Diabetes Association said Sunday that all adults with type 2 diabetes or prediabetes should be screened for nonalcoholic fatty liver disease, an increasingly prevalent condition that can lead to serious liver damage. There are no approved medications for the disease, but among available diabetes drugs, the ADA singled out GLP-1 treatments as an option doctors could consider, according to recommendations published during the annual ADA conference. GLP-1 treatments, such as Ozempic and Mounjaro, are a class of drugs that have grown widely popular for their efficacy not only in lowering blood sugar, but also cutting weight. Drugmakers have started to study them in liver disease, and while some trials have shown they may offer some benefits, they haven’t yet been shown to improve harmful liver scarring. The ADA ...
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