The late 90s marked the beginning of the era of precision oncology, yet recent studies in the U.S. indicate that most cancer patients are not receiving FDA-approved precision therapies. Factors such as high costs, extensive tissue requirements, and lengthy processing times have hampered the broader adoption of precision oncology, often leading to treatments that are not only suboptimal but potentially harmful. A significant barrier is the lack of testing; many cancer patients endure critical delays waiting for standard genomic tests following an initial tumor diagnosis, which can be life-threatening. Now, a groundbreaking advancement has been made with the development of a new generation of artificial intelligence (AI) tools that enable the rapid and cost-effective detection of clinically actionable genomic alterations directly from tumor biopsy slides. This innovation could cut weeks and save thousands of dollars in clinical oncology treatment workflows for diseases like breast and ovarian cancers. The new AI ...
Bayer reported a Phase 3 test of Kerendia in heart failure led to statistically significant reductions in cardiovascular death and hospitalizations. Detailed results will be presented during the European Society of Cardiology annual meeting in September. By Frank Vinluan Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure. Kerendia is a small ...
• Britain and other popular school destinations have reported rise in cases of meningococcal infection Hong Kong parents have been urged to get their children vaccinated against a life-threatening bacterial infection if they are heading overseas to study, following an uptick in cases in Britain and other popular school destinations. The Society of Hospital Pharmacists of Hong Kong made the call on Sunday after a survey it conducted earlier found that most parents were unaware of the health risks of meningococcal infection, to which young children and youths were vulnerable. Its survey in late February revealed that about half of the 110 parents who planned to send their children abroad to study did not know about meningococcal disease and had misconceptions about the potentially fatal infection. Society president So Yiu-wah said many parents had underestimated the health risks of the infection, with 30 per cent thinking it could be treated ...
Researchers from Guy’s and St Thomas’ and King’s College London (KCL) have revealed a certain type of bacteria is toxic for head and neck cancer and could potentially lead to better outcomes for patients. Published in Cancer Communications, the research was funded by Guy’s Cancer Charity and Cancer Research UK through the City of London Cancer Centre. Currently the sixth most common cancer globally, head and neck cancers affect around 1,000 people in the UK every month. When analysing head and neck cancer patients, the team found that those who harboured higher levels of Fusobacterium, which is usually associated with the progression of bowel cancer, had a better prognosis than those with lower levels of the bacteria. In total, there was a 70% to 99% reduction in the number of viable cancer cells in head and neck cancer cell cultures after being infected with the bacterium, as it destroys the ...
WUXI and SUZHOU, China, Aug. 1, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that four manufacturing facilities and Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA), demonstrating the company’s commitment to meeting rigorous international industry quality standards across its global network. Following comprehensive inspections of the company’s facilities– specifically MFG1, MFG2, MFG5, and DP1 in Wuxi– EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company’s capabilities in providing such services for global clients. All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company’s Suzhou Biosafety Testing Center was once again certified by the EMA to provide services ...
By Don Tracy, Associate Editor Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses. Results from the SUMMIT Phase III clinical trial found that Eli Lilly’s tirzepatide, tested at doses of 5 mg, 10 mg, and 15 mg, showed statistically significant improvements in reducing heart failure with preserved ejection fraction (HFpEF) and obesity, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS), compared to placebo. According to the company, tirzepatide also demonstrated improved exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and a noteworthy mean body weight reduction at 52 weeks.1 “HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity.1,2 Despite ...
Belgian biotech Rejuvenate Biomed has teamed up with data and AI solutions company SAS to create a tool for researchers to repurpose existing drugs to tackle age-related diseases at their core. The low-code tool aims to simplify the process of analysing biomedical data. It will use SAS’s analytics to reveal hidden biological patterns and interactions, allowing researchers to create detailed reports with SAS visual analytics. The tool will be built on SAS Viya, a cloud-based AI and data platform. According to the companies, the tool is designed to be user-friendly for researchers who don’t have a wealth of coding experience but will also be powerful enough for advanced teams working on complex biological problems. Founded in 2017, Rejuvenate raised €15.7m ($16.9m) in a Series B round led by Zürich-based biotech Rejuveron Life Sciences in 2021. The funds built on a €3.2m ($3.46m) Series A in the same year. The start-up ...
Oxford-based cell therapy company Adaptimmune Therapeutics has received accelerated approval from the US Food and Drug Administration (FDA) for Tecelra (afamitresgene autoleucel) for treatment of synovial sarcoma. Tecelra is the first engineered cell therapy for solid tumours approved in the US, and represents the first therapy option against synovial sarcoma in more than a decade. It is indicated to treat adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, and whose tumours express the MAGE-A4 antigen. Additionally, the tumours need to have a certain HLA type— HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive. The approval was granted based on results from the Phase II SPEARHEAD-1 trial (NCT04044768). Amongst 44 patients with synovial sarcoma, the overall response rate (ORR) to treatment was 43% with a median duration of response of six months (95% CI: 4.6, not reached). Continued approval remains subject to verification of clinical benefit in further trials. ...
US-based vaccine company HilleVax is slashing its workforce by 40% after its lead vaccine failed a Phase IIb study last month. HilleVax announced that it will let go of 41 employees, after a Phase IIb trial (NCT05836012) with its norovirus vaccine, HIL-214, failed to meet primary and secondary endpoints. The company’s stock plummeted by more than 80% following the 8 July announcement of the failed results. The vaccine showed an efficacy of 5% in the 2,800 infants enrolled in the study aged four months of age at the time of enrolment in the US and Latin American countries, who had norovirus-related acute gastroenteritis (AGE). The study did not meet the key endpoint of demonstrating efficacy against moderate or severe AGE events caused by the GI.1 or GII.4 norovirus genotypes. The experimental vaccine had previously shown success in adults, with one Phase IIb field efficacy trial (NCT02669121) in 4,712 adults showing ...
Scientists have developed an advanced artificial intelligence (AI) approach that can predict the likelihood of developing age-related conditions such as Alzheimer’s and heart disease up to a decade before symptoms manifest. By analyzing blood samples from over 45,000 individuals using machine learning, researchers identified specific protein patterns associated with an increased risk of disease. This capability to predict the probability of developing a health condition before any symptoms are observed could potentially enhance personalized medicine by providing early warnings, thereby opening doors for preventative interventions. Researchers from the University of Edinburgh (Edinburgh, UK) participated in a study that used data from the UK Biobank, which contains genetic and health information from half a million UK participants. They applied AI and machine learning to detect protein patterns in blood that correlate with the onset of common ailments including Alzheimer’s, heart disease, and type 2 diabetes. The analysis was based on medical ...
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