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RedHill Biopharma Secures U.S. Government Funding

RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services (HHS)‘ Administration for Strategic Preparedness and Response (ASPR), has selected opaganib2 for development to treat exposure to Ebola virus disease (EBOV). Under this cost-sharing contract, BARDA will provide partial funding for the company to further advance opaganib to mitigate infection and contain EBOV outbreaks. To date, opaganib has made positive development progress on the expected Animal Rule pathway towards potential approval as a treatment for EBOV. The Animal Rule allows for the use of pivotal animal model efficacy studies to support U.S. Food and Drug Administration (FDA) approval of new drugs when human clinical trials are not ethical or feasible.

Climate change affects emergency medicine worldwide

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International experts in emergency medicine warn that climate change will likely have serious consequences for emergency services worldwide. Nevertheless, few countries have assessed the extent of the impact or have a plan to deal with it. In a special session at the European Congress of Emergency Medicine today (Sunday), Luis Garcia Castrillo, now professor emeritus of emergency medicine at Hospital Marqués de Valdecilla in Santander, Spain, described how he and colleagues from the EUSEM working group on Emergency Medicine Day had asked 42 focus groups, consisting of experts in emergency medicine, preclinical care, and disaster medicine, in 36 countries across 13 UN regions of the world to complete a survey on awareness and preparedness for climate change [1]. The research findings are to be published in the European Journal of Emergency Medicine [2]. “On a scale of 0 to 9, they rated the severity of the impact of climate change on healthcare systems and particularly on emergency care, both now …

FDA Approves IMULDOSA

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The FDA approved IMULDOSA for all indications of its reference medicine, STELARA. Accord anticipates a commercial launch of IMULDOSA in the first half of 2025.


Lilly reports one-year histologic outcomes in Phase 3 study of mirikizumab

Eli Lilly and Company (NYSE: LLY) announced data demonstrating more patients with moderately to severely active Crohn’s disease treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. VIVID-1 is the first Phase 3 study for any approved or investigational treatment in Crohn’s disease to report histologic and combined histologic-endoscopic outcomes that were evaluated using a systematic assessment of five bowel segments (four colonic and one ileal) and strict definitions consistent with the recently published European Crohn’s and Colitis (ECCO) position statement on mucosal histopathology. These results are being presented as an oral presentation at United European Gastroenterology (UEG) Week, held in Vienna, Austria from October 12-15.

Corona Debrief: Drosten and Vaccine Mandate

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Christian Drosten, a renowned German virologist, played a central role in public perception and policy advice during the Corona pandemic[3]. As head of virology at Charité Berlin and co-developer of the first PCR test for SARS-CoV-2, he became one of the most important voices in pandemic control[3]. Drosten already warned in 2017 about the potential of the SARS virus and was instrumental in the early diagnosis of COVID-19[3]. His expertise led him to serve as an advisor to federal and state governments and to frequently appear in the media as the "nation's Corona explainer"[3]. Regarding the COVID-19 vaccination campaign, Drosten held a clear pro-vaccination stance. He repeatedly emphasized the importance of vaccinations in curbing the pandemic[4]. However, Drosten himself had no direct decision-making power over a possible vaccine mandate, as this was ultimately a political decision. The effectiveness of COVID-19 vaccines has been proven by numerous studies. According to the Robert Koch Institute… 

First AI-powered pipeline for personalized cancer vaccines

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Scientists at Ludwig Cancer Research have developed a complete drug pipeline that integrates multiple molecular and genetic analyses of tumors and the specific molecular targets of T cells, using artificial intelligence algorithms to enable personalized cancer vaccines for patients with their results. The design, validation, and comparative evaluation of this computer suite, NeoDisc, are described in detail in the current issue of Nature Biotechnology in a publication led by Florian Huber and Michal Bassani-Sternberg of the Lausanne branch of the Ludwig Institute for Cancer Research. "NeoDisc offers unique insights into the immunobiology of tumors and the mechanisms by which they evade the attack surface for cytotoxic T cells of the immune system," said Bassani-Sternberg. "These insights are invaluable for the development of personalized immunotherapies, and the analytical and computational pipeline that forms the core of NeoDisc is already being used here in Lausanne...

Nanoparticles combat obesity

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Researchers have presented a novel approach to combating obesity that targets fat absorption in the small intestine. The cutting-edge nanoparticle system, designed to deliver therapeutic molecules directly to the digestive tract, has shown significant potential in preventing diet-induced obesity. The study, presented yesterday at UEG Week 2024, focuses on an enzyme called sterol O-acyltransferase 2 (SOAT2), which plays a crucial role in fat absorption in the small intestine.3,4 By inhibiting this enzyme in the small intestine, the study offers a promising therapeutic approach to reducing fat absorption and potentially preventing obesity. Despite extensive research into fat metabolism, effective inhibitors of intestinal fatty acid absorption have not yet emerged. "For years, researchers have been studying fat metabolism, but it has been difficult to find an effective way to block fat absorption," explained lead researcher Dr. Wentao Shao. "While...

Life Sciences: Events to watch

For the period from October 14 to 31, 2024, the following important dates in biotech and medicine should be noted: The PSP Conference 2024, with a focus on health, will take place on October 14 and 15 at the Fraunhofer Conference Center in Potsdam Science Park[1]. This two-day event offers an exciting program with the latest research findings, product innovations, and impulses from the Berlin-Brandenburg capital region. Topics such as personalized medicine, artificial intelligence in medicine, and (digital) diagnostics are the focus[1]. On October 14, 2024, XChange 2024 will take place in Munich, addressing the topic of Artificial Intelligence in Radiation Therapy[2]. This event offers experts the opportunity to exchange ideas about the latest developments in this field. The Biointelligence Congress is planned for October 22, 2024, in Stuttgart[1]. This event brings together professionals from various fields of biotechnology and bioinformatics to discuss innovative approaches and technologies… 

Mavacamten  Improves Cardiac Biomarkers in HFpEF Patients

Mavacamten, a drug originally developed to treat hypertrophic cardiomyopathy, has shown signs of reducing cardiac strain in patients with heart failure with preserved ejection fraction. Heart failure with preserved ejection fraction (HFpEF) affects nearly half of all heart failure patients. It is characterized by the heart's inability to fill with blood adequately, despite normal pumping function. Patients with a left ventricular ejection fraction (LVEF) of 60% or higher constitute 43% to 46% of HFpEF patients. These individuals often respond less favorably to standard heart failure treatments, limiting effective therapeutic options. Mavacamten is a cardiac myosin inhibitor already approved for treating hypertrophic cardiomyopathy (HCM), demonstrating its ability to lower certain biomarkers in non-obstructive HCM cases. Researchers hypothesized that similar mechanisms could benefit HFpEF patients by improving cardiac muscle relaxation and… 

Children: Early sleepers have greater microbial diversity in gut flora

Researchers from the Department of Pediatric Rehabilitation in China have found significant differences in the gut flora of children who go to bed early compared to those who stay up late. The study found that children with earlier bedtimes had greater microbial diversity in their gut flora. Previous studies have shown that adequate sleep improves academic performance and physical growth and is associated with a healthier BMI. The current study examined the relationship between children's sleep behavior and their gut flora. Genomic analysis revealed that children who went to bed early had higher levels of certain beneficial gut bacteria. In particular, Akkermansia muciniphila was significantly more prevalent in the group that went to bed early. Other elevated bacterial levels in early sleepers included Holdemania filiformis, Firmicutes bacterium CAG-95, Streptococcus sp. A12, Weissella confusa, Clostridium sp. CAG-253, Alistipes finegoldii, and Eubacterium siraeum. Additionally, levels of...