Search Results for “AI” – Page 43 – media

Newly discovered synthetic adjuvant materials could make vaccines more accessible, sustainable

New raw vaccine materials that could make vaccines more accessible, sustainable, and ethical have been discovered. Adjuvants are vaccine ingredients that boost a person’s immune response to a vaccine, providing greater protection against disease. One of the most prevalent adjuvant materials used in vaccines is squalene, which is typically sourced from shark livers. Researchers at the University of Nottingham collaborated with the Access to Advanced Health Institute (AAHI) to identify synthetic alternatives to squalene that ensure sustainable, reliable, and ethical sourcing of adjuvant raw materials for vaccines moving forward. New synthetic adjuvant materials were developed from commercially available methacrylate monomers, ensuring that a reliable supply of the material is continually available. The combination of these adjuvant materials are scalable through catalytic chain transfer polymerization, a process that allows high levels of control over the molecular weight of the product polymer. Controlling the molecular weight is key to the use of ...
- Source: drugdu
- 115
- October 16, 2023
After Novo’s Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. But dialysis bigwig DaVita—whose future business could be on the line—is making its skepticism known. Based on the inclusion criteria for CKD patients in Novo Nordisk’s FLOW trial, which stopped early this week after hitting pre-specified criteria for efficacy, DaVita believes there may only be “limited application” of the findings to the overall CKD population. DaVita, which shares a significant chunk of the dialysis industry with its German rival Fresenius, admitted it’s “nearly impossible” to draw any conclusions from Novo’s study at this point, given that the detailed results are still under wraps. Emboldened by Ozempic’s performance thus far, Novo on Wednesday said it would begin powering down FLOW on the advice of the study’s independent data monitoring committee. The company expects the ...
- Source: drugdu
- 136
- October 14, 2023
European Commission orders Illumina to divest Grail

Dive Brief The European Commission on Thursday ordered Illumina to unwind its 2021 acquisition of liquid biopsy-maker Grail, establishing deadlines for the company to follow as well as potential penalties for non-compliance. The commission in September 2022 prohibited Illumina from buying Grail, maker of a blood-based early cancer detection test, over concerns that the merger would stifle innovation in the emerging market. Illumina and Grail completed the $8 billion deal anyway, in an alleged breach of EU merger control rules. Illumina, which is appealing the EC’s decision, said in a statement Thursday that it was reviewing the order. Dive Insight Illumina has been expecting the EC’s divestment instructions while maintaining that the commission does not have jurisdiction over the merger. The gene-sequencing industry leader is appealing the jurisdictional issue with the European Court of Justice. The company has said it will pursue parallel paths, working to divest Grail according to ...
- Source: drugdu
- 188
- October 14, 2023
Mount Sinai researchers receive NIH grant to compare new treatment options for sickle cell disease

The Mount Sinai Health System has received a $12,180,625 grant from the National Heart, Lung and Blood Institute to compare new treatment options for sickle cell disease and determine which work best for specific patients. Jeffrey Glassberg, MD, Director of the Mount Sinai Sickle Cell Program, said, “Sickle cell traditionally has been a neglected disease, but it benefited from a flurry of innovation over the last decade and there are now three new medications approved for the disease.” “While this is welcome news, clinicians now have a new challenge. No studies have compared the drugs to each other or looked at their use in combination, so there’s very little information to help decide which of the new drugs are best for which patients.” The study, known as REAL (Registry Expansion Analyses to Learn) Answers, is a collaboration among 10 sickle cell centers across the United States that will implement a ...
- Source: drugdu
- 161
- October 14, 2023
After FDA snub, Lilly’s mirikizumab looks to regain momentum with phase 3 Crohn’s win

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 Crohn’s disease study. The interleukin-23p19 antagonist achieved both primary endpoints and all of its major secondary endpoints in the VIVID-1 study, Lilly said in a Thursday release. The trial results will serve as the basis of regulatory submissions in the disease next year, the company added. In the study, Lilly’s drug helped 54.1% of participants achieve clinical remission at week 52, compared with 19.6% for those on placebo. However, the drug couldn’t prove superiority in the endoscopic response measure when pitted against Johnson & Johnson’s star immunosuppressant Stelara (ustekinumab). Still, mirikizumab’s results were “numerically higher” than its J&J counterpart, Lilly said. Lilly will pursue approval in Crohn’s in 2024, when it will submit a marketing application ...
- Source: drugdu
- 118
- October 13, 2023
Study supports genetic predisposition to chronic regional pain syndrome in a third of cases

Genes may be responsible for third of complex regional pain syndrome cases. But the condition is less common in men, even though they are more likely to have the 4 genetic variations implicated in heightened risk, suggesting that there may be sex specific causes, say the researchers. Most cases of CRPS are usually triggered by an injury, with the skin of the affected body part hypersensitive to the slightest touch or temperature change. CRPS is difficult to treat, and while it often improves with time, some people experience intense pain for many years. But why some people develop CRPS yet others don’t after the same injury, isn’t clear. A heritable component to CRPS has been suggested, sparking the theory that some people might be genetically predisposed to the condition. To explore this further, the researchers looked for variations in genes, formally known as single nucleotide polymorphisms, or SNPs for short, ...
- Source: drugdu
- 236
- October 12, 2023
New University of Bristol study to aid strep A vaccine development

The study will offer new insights into the immune system’s response to iGAS Spencer Dayman Meningitis Research has announced that scientists at the University of Bristol have begun a research project to aid in the development of a vaccine against invasive group A streptococcus (iGAS). The study will offer new and unique insights into the adaptive immune response to iGAS. iGAS is a severe infection caused by bacteria invading parts of the body, including the blood, deep muscle, fat tissues or lungs, which can lead to diseases such as meningitis and sepsis. Since April 2023, there have been 3,287 cases of iGAS in the UK, 761 of which occurred in children aged 18 years and under. There is currently no vaccine to protect individuals from group A streptococcus, which can also cause rheumatic fever and scarlet fever. Funded by Spencer Dayman Meningitis Research, scientists Dr Ana Goenka, Dr Alice Halliday ...
- Source: drugdu
- 128
- October 12, 2023
ABVC BioPharma obtains patent for MDD treatment in Taiwan

ABVC BioPharma has obtained a patent in Taiwan for the use of PDC-1421 in ABV-1504, an asset that treats major depressive disorder (MDD). PDC-1421 is an extract of Radix Polygala. In April 2023, the company received a patent for the same treatment in the US. Data from the latest studies showed that PDC-1421 should be given orally as a capsule for a minimum of 25 days. Doses ranged from once to three times per day. ABVC CEO Dr Uttam Patil stated: “These patents grant ABVC the right to exclude others from using, offering or selling PDC-1421 throughout the US and Taiwan until the year 2040. “As our patent map steps into global coverage, we eagerly await the results of patent applications in the European Union, China, Japan and more.” ABV-1504 is an inhibitor of norepinephrine transporter. The company has concluded Phase II clinical trials of ABV-1504 containing PDC-1421 and intends ...
- Source: drugdu
- 159
- October 11, 2023
FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024. By FRANK VINLUAN An Alnylam Pharmaceuticals drug developed to treat a rare disease’s potentially fatal effects on the heart has fallen short in its bid for FDA approval, costing the company a chance to immediately challenge a Pfizer product that has become a blockbuster seller in the indication. But the biotech still has another chance with a different drug in late-stage development that could offer patients a better alternative. Alnylam was seeking approval of its drug, Onpattro, as a treatment for cardiomyopathy caused by hereditary transthyretin amyloidosis (hATTR). According to the Cambridge, Massachusetts-based company, the FDA’s complete response letter said ...
- Source: drugdu
- 219
- October 11, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 199
- October 10, 2023

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