Immune checkpoint inhibitors are a form of immunotherapy drug that enables immune cells to target and destroy cancer cells. At present, the Food and Drug Administration has approved two predictive biomarkers for identifying patients who might benefit from immune checkpoint inhibitors. The first biomarker is tumor mutational burden, which measures the number of mutations in the DNA of cancer cells. The second biomarker is PD-L1, a protein found on tumor cells that inhibits the immune response and is targeted by some immune checkpoint inhibitors. However, these biomarkers are not always reliable in predicting a patient’s response to immune checkpoint inhibitors. Recent machine-learning models utilizing molecular sequencing data have demonstrated potential in predicting responses, but this data is costly and not routinely collected. Researchers have now created an artificial intelligence (AI) tool that uses standard clinical data, such as results from a basic blood test, to predict if a patient’s cancer ...
The Polymerase Chain Reaction (PCR) is widely regarded as the definitive method for target DNA sequence amplification, testing, and analysis. In this traditional PCR process, the DNA sample undergoes heating to separate into single strands, which then serve as templates for synthesizing new DNA strands through enzymatic action. Despite its effectiveness, this method can be cumbersome, slow, and costly. Now, researchers have introduced an alternative DNA testing method that could potentially replace traditional PCR, paving the way for broader applications in medical diagnostics. Developed at Case Western Reserve University (Cleveland, OH, USA), this new technique or reaction is named AMPLON (Amplifying DNA with Multiarm Priming and Looping Optimization of Nucleic Acid). It enables comparison of DNA from diseased cells with that from healthy ones, enhancing understanding of disease progression and treatment approaches. AMPLON uses multiple extensions along the DNA strand, significantly enhancing the speed and accuracy of DNA synthesis at ...
German science and technology company Merck KGaA has announced the opening of its expanded Life Science distribution centre at Schnelldorf, which involved an investment of €180m ($195.7m). With this investment, the facility has almost doubled in size, adding 25,000m² to its area. The development bolsters the company’s capacity to meet the surging global demand for critical drugs and contribute to public health significantly. The newly expanded site now features a manual down-filling operation and an extra distribution area for a wide array of products destined for laboratories and research institutions worldwide. The Schnelldorf centre’s workforce comprises 470 specialists including engineers, and manufacturing and distribution experts. The site expansion is part of the company’s multi-year investment programme in the life science business sector. The company has announced projects worth more than €2bn since 2020. They span Europe, China and the US, reflecting the company’s strategic focus on enhancing industrial capacity and ...
Orchid Pharma has secured approval from the Drugs Controller General of India (DCGI) to manufacture and market its new chemical entity (NCE), the active pharmaceutical ingredient (API) Enmetazobactam. The DCGI also approved the production and marketing of the finished dosage form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable. The antibiotic drug combination is specifically indicated for complicated urinary tract infections (cUTI), including the treatment of acute pyelonephritis. Other indications comprise hospital-acquired pneumonia (HAP), ventilator-associated pneumonia, and bacteremia when associated with or suspected to be linked to either cUTI or HAP. Orchid Pharma’s new combination drug addresses the urgent need for effective treatments against severe infections caused by resistant bacteria, a critical concern in the global health community’s fight against antimicrobial resistance (AMR). The United Nations and the World Health Organization have declared AMR to be a “silent pandemic”, attributing to five million deaths in 2019. The company ...
Resolution Therapeutics Limited, in collaboration with the University of Edinburgh, has presented compelling clinical data at the EASL Congress 2024 in Milan, Italy, showcasing the significant potential of macrophage cell therapy for treating advanced liver cirrhosis. The MATCH Phase 2 study, led by Dr Paul Brennan from the University of Dundee and Professor Stuart Forbes, has revealed that autologous non-engineered macrophages are safe and effective for patients with liver cirrhosis, showing a marked improvement in patient survival and transplant-free survival over thirty months post-randomisation. Professor Forbes – a founder of Resolution Therapeutics and Professor of Transplantation and Regenerative Medicine at the University of Edinburgh – reflected: “We are greatly encouraged by the data from the MATCH Phase 2 study and this long-term follow-up study. We will continue monitoring patients with the aim of reporting further data at the AASLD meeting in November 2024.” Resolution has also introduced a proprietary discovery ...
Sanofi’s Sarclisa, a novel treatment for multiple myeloma, has demonstrated a substantial improvement in progression-free survival for patients ineligible for transplant. The phase 3 IMROZ study revealed that Sarclisa (also known as isatuximab), combined with a VRd regimen, reduced the risk of disease progression or death by 40% compared to VRd alone. The study, which was presented at the American Society of Clinical Oncology (ASCO) annual meeting, marks a significant advancement in the treatment of newly diagnosed multiple myeloma (NDMM). The full data, published in the New England Journal of Medicine, will inform future regulatory submissions. Professor Graham Jackson, a haematologist and advisor for Myeloma UK, highlighted the importance of the findings: “Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed multiple myeloma patients. He added: “The significant progression-free survival demonstrated in the IMROZ study reinforces the potential of isatuximab-VRd to improve outcomes for newly ...
Don Tracy, Associate Editor Results of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.AstraZeneca announced a significant milestone from the ADRIATIC trial, which is evaluating the safety and efficacy of Imfinzi (durvalumab) for the treatment of limited-stage small cell lung cancer (LS-SCLC) in patients who haven’t progressed following concurrent chemoradiotherapycCRT. According to the company, the trial found that administration of Imfinzi after standard-of-care cCRT greatly improves overall survival (OS) and progression-free survival (PFS) compared to placebo. These results were presented at the 2024 American Society of Clinical Oncology Annual Meeting during the Plenary Session.1 “The ADRIATIC results represent a breakthrough in limited-stage small cell lung cancer, a highly aggressive disease where recurrence rates are high and only 15 to 30 per cent of patients survive five years,” said David R. Spigel, chief ...
In a 2024 sexually transmitted infections (STIs) surveillance report by the World Health Organization (WHO), over 2.5 million cases were recorded, alongside a rise in the inappropriate use of antibiotics to treat these STIs. This misuse has contributed to the development of antimicrobial-resistant strains of Neisseria gonorrhoeae (NG), prompting WHO to issue new guidelines for diagnosing STIs, including the use of point-of-care (POC) tests, focusing particularly on reducing antimicrobial resistance. The increasing STI rates have posed a significant challenge to hospital emergency departments, as traditional tests do not yield results quickly enough to guide treatment decisions during a patient’s visit. Consequently, clinicians often must decide on treatment before obtaining definitive results, exacerbating the issue of antibiotic resistance. Now, a new study has demonstrated that a POC polymerase chain reaction (PCR) test can reduce the time from specimen collection to STI result to just 47 minutes per patient, compared to the ...
California-based biotech Quince Therapeutics has won fast track designation from the US Food and Drug Administration (FDA) for its ataxia-telangiectasia (A-T) drug EryDex. According to the 3 June announcement, fast track designation was awarded to address a high unmet medical need for patients with A-T. The status allows for earlier interactions with the FDA as Quince seeks accelerated approval, and also the possibility to undergo rolling reviews. A-T is a rare disease of the nervous and immune systems, affecting motor movement and speech. EryDex utilises autologous intracellular drug encapsulation (AIDE) technology to administer dexamethasone sodium phosphate (DSP) into a patient’s red blood cells. Red blood cells filled with DSP are then reinfused into the patient, allowing for the slow release of steroids over several weeks, without the long-term toxicity commonly associated with chronic administration. The FDA lifted a partial clinical hold that was on the drug in October 2023, advancing ...
On May 21st, Weiguang Biological officially obtained the Certificate of Drug Registration of Human Plasminogen Complex approved by the State Drug Administration, adding one new product to its product pipeline! Up to now, Weiguang Bio has 11 products in three categories of blood products, and the comprehensive plasma utilization rate ranks the leading level in the industry. Prothrombin Complex Concentrate (PCC) approved by Weiguang is a concentrated preparation rich in coagulation factors II, VII, IX and X made from healthy human plasma, separated and purified by gel adsorption, ultrafiltration and other advanced technologies, and lyophilized by S/D and dry heat viral inactivation process. The ratio of Factor II, Factor VII, Factor IX and Factor X in the finished product is 1:1:1:1, all of them are 300IU, which is one of the rare four-factor PCC in the industry, and the quality of the product is at the leading level in the ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.