A new solution, known as E-MOTIVE, could provide a major breakthrough in reducing deaths from childbirth-related bleeding, according to a landmark study published today (May 9) in the New England Journal of Medicine by researchers from the World Health Organization (WHO) and the University of Birmingham. Postpartum hemorrhage (PPH)—defined as the loss of more than 500 mL of blood within 24 hours after birth—is the leading cause of maternal mortality worldwide. It affects an estimated 14 million women each year and results in around 70,000 deaths, mostly in low and middle-income countries, equivalent to one death every six minutes. “Postpartum hemorrhage is scary, not always predictable, but absolutely treatable. Nonetheless, its impacts around the world are tragic,” said Dr. Pascale Allotey, Director of Sexual and Reproductive Health and Research at WHO and head of the United Nations’ Special Program of Research, Development and Research Training in Human Reproduction (HRP). ...
EQRx, a high-profile startup that attempted to build a new pharmaceutical business model, will lay off a large portion of its staff and discard much of its drug pipeline in a large-scale reset announced Monday. Launched by veteran biotech venture capitalist Alexis Borisy, EQRx started up in early 2020 with grand plans to reimagine how prescription drugs are developed and priced. The company claimed it could invent or license similar, but more effective competitors to top-selling specialty medicines, such as those for cancer, and sell them for less — a vision EQRx executives used to raise more than $2 billion in funding. EQRx made some progress, licensing several cancer drugs from Chinese companies and advancing them into late-stage clinical testing. But its near-term plans were thrown into disarray by the Food and Drug Administration, which set out stricter approval standards for drugs developed and tested in China. EQRx pivoted ...
Going beyond pregnancy and COVID-19, the world could someday soon come to rely on at-home tests for many diseases thanks in part to AI-fueled improvements. University of Florida scientists have used artificial intelligence tools to simplify a test that works for both hepatitis C and SARS-CoV-2, the virus that causes COVID-19. The simplified test happens in one small test tube in just a few minutes. With further refinement, it could come to doctor’s offices soon and, one day, even home tests that are as easy as a pregnancy test. “We are trying to build a home-based test that is as reliable as a lab-based test,” said Piyush Jain, a UF professor of chemical engineering who led the latest research. “We are trying to make the test simple, eliminate the need for expensive equipment and provide results in just 10 to 20 minutes.” To accomplish those goals, Jain’s group is innovating ...
Researchers at the UCLA David Geffen School of Medicine, the Howard Hughes Medical Institute at UCLA and the National Institutes of Health have developed a zebrafish model that provides new insight into how the brain acquires essential omega-3 fatty acids, including docosahexaenoic acid (DHA) and linolenic acid (ALA). Their findings, published in Nature Communications, have the potential to improve understanding of lipid transport across the blood-brain barrier and of disruptions in this process that can lead to birth defects or neurological conditions. The model may also enable researchers to design drug molecules that are capable of directly reaching the brain. Omega-3 fatty acids are considered essential because the body cannot make them and must obtain them through foods, such as fish, nuts and seeds. DHA levels are especially high in the brain and important for a healthy nervous system. Infants obtain DHA from breastmilk or formula, and deficiencies of ...
For Catalent, the hits keep coming. After an April communique warning of reduced sales and productivity issues at three separate plants, the CDMO juggernaut delayed the release of its earnings for the third fiscal quarter. The report was originally scheduled to roll out Tuesday. Catalent said in a release Monday it’s now angling to unveil is quarterly report on May 15. Last month, Catalent said manufacturing hurdles at three major production sites—including two of the contract manufacturer’s largest—were expected to put a squeeze on third-quarter earnings and weigh on the company’s outlook for the entire fiscal year, which runs through the first half of 2023. Now, in addition to those “operational challenges,” Catalent says it has “also since identified significant issues with its forecasts over the past year.” With that mix of operational and productivity hangups, plus “prior forecasting challenges,” Catalent expects to “significantly reduce” both its 2023 revenue and EBITDA ...
For individuals with depression, the most common causes of hospitalization are endocrine, musculoskeletal, and vascular diseases, according to a study published online May 3 in JAMA Psychiatry. Philipp Frank, Ph.D., from University College London, and colleagues examined the association between depression and physical conditions requiring hospitalization in a prospective multicohort study. The primary analysis was based on data from the U.K. Biobank (130,652 individuals), and analyses were repeated in an independent dataset of two cohorts in Finland (109,781 individuals). The researchers found that severe/moderately severe depression was associated with the incidence of 29 nonoverlapping conditions requiring hospital treatment during five years of follow-up in the main analysis. After adjustment for confounders and multiple testing, 25 of these associations remained (adjusted hazard ratio range, 1.52 to 23.03) and were confirmed in the independent dataset. The highest cumulative incidence was seen for endocrine and related internal organ diseases, musculoskeletal diseases, and diseases of the circulatory system and blood (245, ...
After the European Commission proposed a massive overhaul to the EU’s drug legislation, a group of 19 European countries is launching an effort to reduce the bloc’s supply chain reliance on outside countries. The position paper (PDF) urges the EU to “take more drastic steps” to improve the security of Europe’s supply of medicines. Belgium is leading the charge, and 18 other countries such as France, Germany and Spain are on board. In 2019, more than 40% of global active pharmaceutical ingredients came from China, the countries point out. That, coupled with other factors such as the fact that “almost all API producers depend on China for intermediate inputs,” make Europe and the rest of the world dependent on “a few manufacturers for a large bulk of their medicines supply,” according to the paper. The proposed European Critical Medicine Act would follow in the footsteps of similar acts such as the Critical Raw Materials Act ...
In the first year of Covid-19, Medicare paid providers $1 billion for psychotherapy services, and $580 million were improper payments, including $348 million that were for telehealth services, a recent audit by the Office of Inspector General (OIG) found. The OIG audit, published Tuesday, analyzed $1 billion in Part B payments for more than 13.5 million psychotherapy services from March 2020 through February 2021. Its analysis consisted of two random samples of psychotherapy services: a sample of 111 enrollee days for telehealth services and a sample of 105 enrollee days for non-telehealth services. An enrollee day includes “all claim lines for Medicare Part B psychotherapy services with the same service start date for a specific enrollee,” the OIG said. Audits from before the pandemic showed improper payments for psychotherapy services, leading the agency to examine payments during the pandemic when telehealth access was greatly expanded. “Because of the significant increase ...
A newer, more effective treatment for uterine fibroids is available that doesn’t require surgery. That’s good news for the estimated 26 million women in the U.S. who have fibroids—including the millions of Black women who are disproportionately affected by these benign tumors. Black women in the U.S. are up to three times more likely to develop fibroids than white women. Dr. Elizabeth Stewart, a Mayo Clinic gynecologist and researcher, recently published a review on these approved fibroid medications. They are called oral gonadotropin-releasing hormone (GnRH) antagonist combinations. “There are two new FDA-approved drugs for the medical treatment of uterine fibroids,” says Dr. Stewart. Dr. Stewart says the drugs are effective in treating heavy menstrual bleeding, relieving pain and reducing the need for a hysterectomy. “Because many women are pushed in the direction of surgical therapy, and we know there are big limitations to surgical therapies, this is a great treatment option for many ...
Just last week, GLP-1 giant Novo Nordisk promised a supply boost of its in-demand obesity med Wegovy after lining up a second contract manufacturer. Now, though, the company is “temporarily” reducing U.S. supply of lower dosage strengths to “safeguard continuity of care,” the company said in a statement. The company sees a “short-term need” to cut back on starter doses of the drug,” CEO Lars Fruergaard Jørgensen said on the company’s first-quarter earnings call Thursday. The CEO added that manufacturing is “running well” and that the reduction will play out over a “limited period.” “We’re not out of the market with the low dose strengths. We’re just reducing supply,” Jørgensen said, noting that patients will still be able to get the product, just possibly with a longer wait time. Meanwhile, the Danish drugmaker posted huge obesity revenue gains of 124% versus last year’s first quarter, rising to 7.8 billion ...
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