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Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy

Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy. A capsule filled with bacteria is now FDA approved for treating a serious and potentially deadly type of gut infection, making the Seres Therapeutics drug the first oral microbiome therapy to receive the regulatory go-ahead for patients. The infection is caused by Clostridioides difficile (C. difficile or C. diff), a bacterium that’s part of the diverse microbial community in the intestines. When the gut microbiome is disrupted, C. diff can proliferate, releasing toxins that cause frequent diarrhea, abdominal pain, and fever. In severe cases, the infection leads to organ failure and death. Antibiotics can treat C. diff infection, but these bacteria can develop resistance, leading to a recurrence of the infection. When that happens, patients have limited treatment options. According to Centers for Disease Control and Prevention data cited by Seres, about 156,000 cases of ...
- Source: drugdu
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- May 2, 2023
‘Eat, sleep, console’ reduces hospital stay and need for medication among opioid-exposed infants

Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine. “Medical care for newborns who were ...
- Source: drugdu
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- May 2, 2023
Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially available product. ...
- Source: drugdu
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- May 2, 2023
New Blood Test May Reduce Invasive Surgeries for Bladder Cancer

By LabMedica International staff writers One of the methods for treating bladder cancer involves the use of chemotherapy and/or radiation therapy, followed by a radical cystectomy only for patients who do not achieve a complete response. Those who do achieve a complete response are closely monitored following chemotherapy and/or radiation and undergo radical cystectomy if cancer reoccurs. However, radical cystectomy is a significant operation that necessitates urinary diversion, leading to life-altering consequences. Now, a new blood test may enable bladder cancer patients to avoid a precautionary cystectomy after immunotherapy treatment. Scientists at the Netherlands Cancer Institute (NKI, Amsterdam, Netherlands) in collaboration with Inivata (Cambridge, UK) have demonstrated that a novel technique can improve the prediction of tumor recurrence. In the study, the scientists examined the blood of bladder cancer patients who had undergone immunotherapy. These patients were part of a high-risk group with an increased likelihood of disease recurrence, placing ...
- Source: drugdu
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- May 2, 2023
Addressing the much-needed development of effective pneumococcal vaccination policies for long-term care settings

The International Federation on Ageing (IFA) is proud to release findings from a recent study entitled Driving the Agenda of Pneumococcal Pneumonia Vaccination in At-risk Populations in Community and Long-term Care. The COVID-19 pandemic has exposed the brutal nature and impact of respiratory infections on people of all ages and particularly amongst those at-risk of serious complications, such as older adults in long-term care (LTC) settings. Though several respiratory infections and other vaccine-preventable diseases (VPDs) can be prevented, or their severe symptoms reduced through receiving vaccines, current vaccination uptake rates for pneumococcal disease among older adults in LTC are below national targets. This study conducted by the IFA looked at the status of existing public health policies and campaigns on pneumococcal disease in Canadian LTC settings and investigated the policy gaps that have resulted in poor vaccine uptake. One of the main findings from this study is that within LTC ...
- Source: https://www.news-medical.net/news/20230429/Addressing-the-much-needed-development-of-effective-pneumococcal-vaccination-policies-for-long-term-care-settings.aspx
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pneumococcal vaccination policies
Long siesta-takers have higher BMIs and more likely to have metabolic syndrome

Through data-analysis, researchers found that people taking long siestas had higher body mass indexes and were more likely to have metabolic syndrome than those who did not take siestas. It is a common custom in some countries for individuals to take a siesta or midday nap. Sleeping during the middle of the day has the potential to affect sleep quality, cognitive function, and metabolic processes. However, the relationship between siestas and metabolic health is not well understood. A new study led by investigators from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, assessed more than 3,000 adults from a Mediterranean population, examining the relationship of siestas and siesta duration with obesity and metabolic syndrome. The researchers found that those who took siestas of 30 minutes or longer (long siestas) were more likely to have a higher body mass index, higher blood pressure, and ...
- Source: drugdu
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- May 1, 2023
FDA clears Pfizer’s pneumococcal vaccine for infants and children

Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly against strains that weren’t ...
- Source: drugdu
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- May 1, 2023
Doctors watching for more cases after mysterious cluster of brain infections strikes kids in southern Nevada

Disease detectives with the US Centers for Disease Control and Prevention are investigating a cluster of rare and serious brain abscesses in kids in and around Las Vegas, Nevada, and doctors from other parts of the country say they may be seeing a rise in cases, too. In 2022, the number of brain abscesses in kids tripled in Nevada, rising from an average of four to five a year to 18. “In my 20 years’ experience, I’ve never seen anything like it,” said Dr. Taryn Bragg, an associate professor at the University of Utah who treated the cases. Pediatric neurosurgeons like Bragg are rare. She is the only one for the entire state of Nevada, and because she treated all the cases, she was the first to notice the pattern and to alert local public health officials. “After March of 2022, there was just a ...
- Source: drugdu
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- May 1, 2023
Quest to Reach Another Segment in Liquid Biopsy with New M&A

Omar Ford Quest Diagnostics is diving into a quickly growing segment of liquid biopsy with its latest M&A prospect. The Secaucus, NJ-based company announced a definitive agreement to acquire Haystack Oncology in an all-cash equity transaction. Quest will pay $300 million in cash at closing and Haystack has the potential to obtain up to an additional $150 million in performance milestones. If the deal were to close, then Quest would inherit Baltimore, MD – based Haystack’s minimal residual disease testing technology. MRD testing is a specific category of liquid biopsy that identifies circulating tumor DNA (ctDNA) in the bloodstream of patients following surgery and treatment for cancer. In a prospective, multi-institution study published in the New England Journal of Medicine in June 2022, an earlier version of the Haystack technology demonstrated the ability to better identify patients with residual disease for adjuvant chemotherapy after surgery for stage II colon cancer, thereby reducing ...
- Source: drugdu
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- May 1, 2023
Biomarker Signature Test Predicts Which Tumors Will Respond to Immunotherapy

By LabMedica International staff writers Bladder cancer is often fatal, and survival rates have not improved in the past 30 years. Although immunotherapy has revolutionized bladder cancer treatment, it has significant limitations, as most patients do not respond to the therapy. Checkpoint immunotherapy drugs, which enable the body’s immune system to recognize tumors, are effective for only about 20% of bladder cancers. However, it is unclear which patients will benefit and why these drugs are not more effective for all patients. In a breakthrough that could enhance bladder cancer patients’ survival, researchers have now developed a biomarker signature test to predict which tumors will be responsive to immunotherapy. In the new study, scientists at Northwestern Medicine (Chicago, IL, USA), along with multiple international collaborators, identified three types of tumors that could respond to immunotherapy and two that could not. By employing a combination of gene expression profiling, mutations, and spatial ...
- Source: drugdu
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- May 1, 2023

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