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FDA Approves Roche’s HPV Self-Collection Solution, Allowing Patients to Gather Their Own Samples in a Healthcare Setting

Don Tracy, Associate Editor Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States. Roche announced that the FDA has approved its human papillomavirus(HPV) self-collection solution, one of the first of its kind approved in the United States. According to the company, the new tool allows individuals to collect their own samples in a healthcare setting for HPV testing, supporting early detection and prevention of cervical cancer. Analyzed through Roche’s Cobas molecule instrument, positive results require follow-up care with a healthcare provider. Roche’s fully automated Cobas 5800/6800/8800 Systems can provide up to 96 results in approximately three hours, 384 results for the Cobas 6800 System, and 1,056 results for the Cobas 8800 System in eight hours.1 “With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, ...
- Source: drugdu
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- May 17, 2024
US study reveals interferon combinations cause lupus symptoms and affect treatment

The autoimmune disease, which affects 1.5 million people in the US, causes the body’s immune system to attack its own tissues Researchers from Johns Hopkins Medicine have revealed that certain combinations of antiviral proteins are responsible for symptoms and affect treatment outcomes for patients with lupus. Published in Cell Reports Medicine, researchers suggest that the findings could lead to changes in how clinicians treat patients with the condition. Affecting up to 1.5 million people in the US, lupus is a chronic autoimmune disease that causes the body’s immune system to attack its own tissues. In clinical trials for lupus treatments designed to suppress interferon I, researchers observed that patients’ conditions failed to improve, despite genetic testing showing high interferon I levels prior to treatment. The team predicted that two other interferon groups, interferon II and interferon III, could be the reason for poor treatment responses in lupus patients. Looking at ...
- Source: drugdu
- 119
- May 17, 2024
NIHR and TJBCM announce new funding initiative for novel brain tumour research

The condition is the ninth most common cancer in the UK and affects 12,300 people annually The National Institute for Health and Care Research (NIHR) and the Tessa Jowell Brain Cancer Mission (TJBCM) have announced a new innovative package of research funding to stimulate brain tumour research in adults, children and young people. The announcement emerges from a collaboration between charities, research funders and the government, which pledged £40m to develop new lifesaving and life-improving research. Currently the ninth most common cancer in the UK, affecting around 12,300 people every year, according to the Brain Tumour Charity, brain tumours occur when a growth of cells in the brain multiplies in an abnormal, uncontrollable way. In 2018, members of the brain tumour community united to design a national strategy and the government committed funding for new research, following the late Dame Tessa Jowell’s call to action on behalf of brain tumour ...
- Source: drugdu
- 91
- May 17, 2024
First Patient Dosed for MRCT Phase 3 Study on First-Line mCRC of Henlius Anti-PD-1 mAb Serplulimab

Shanghai, China, May 15, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in the phase 3 stage of the international multi-centre clinical trial (ASTRUM-015) of the company’s self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC). The leading principal investigator is Professor Rui-Hua Xu from Sun Yat-sen University Cancer Center and State Key Laboratory of Oncology in South China. Currently, for mCRC patients, immunotherapies have been proven to bring hope to patients with mismatch repair deficiency (dMMR)/microsatellite instability-high (MSI-H) but have not yet shown meaningful positive outcomes in those with proficient mismatch repair (pMMR)/ microsatellite stable (MSS), and there is no immunotherapy approved globally for the first-line treatment of mCRC. HANSIZHUANG is expected to become the world’s first anti-PD-1 mAb for the first-line treatment of mCRC. Colorectal cancer (CRC) is one of the most ...
- Source: drugdu
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- May 17, 2024
Companies prepare for ADC trial readouts at ASCO 2024

As the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting approaches at the end of this month, Merck & Co joined a host of other companies that have announced upcoming data presentations for their oncology clinical studies at the event. The ASCO annual meeting, taking place from 31 May to 4 June, gathers pharmaceutical companies, healthcare providers and experts, to discuss the latest trends in oncology and share new data from ongoing and completed clinical studies. In the last few days, several companies such as Merck & Co, Astellas, and Pfizer have announced upcoming data presentations to look for at the premier cancer conference. In a 15 May press release, Merck & Co announced that it would present data from its Phase III study (NCT06312176), investigating the antibody-drug conjugate therapy (ADC), Sac-TMT (sacituzumab tirumotecan), in previously treated locally recurrent or metastatic triple-negative breast cancer. Pfizer will also be presenting ...
- Source: drugdu
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- May 17, 2024
Medical Fair China 2024

Organiser:Messe Düsseldorf Time:21- 23 August 2024 address：No. 688 East Suzhou Avenue, Suzhou Industrial Park, Suzhou City Exhibition hall: Suzhou International Expo Centre, China Product range: Hospital facilities and equipment: Medical electronic instruments, ultrasound instruments, X-ray equipment, medical optical instruments, clinical examination and analysis instruments, dental equipment and materials, hemodialysis equipment, anesthesia and respiratory equipment, disposable medical supplies, dressings and hygiene materials, all kinds of surgical instruments Hospital wards, operating rooms, emergency room equipment, hospital office equipment, laboratory equipment, beds, operating tables, operating table spotlights, inspection Check the bed, gums and all kinds of hospital furniture Medical care equipment: all kinds of medical and home rehabilitation physiotherapy products About CDMEE： Jiangsu Suzhou Medical Device Innovation Exhibition (Medical Fair China) with the theme of “smart health”, directly and comprehensively serving the medical device industry from the source to the terminal of the entire medical industry chain. Gather advanced medical technology products at ...
- Source: drugdu
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- May 17, 2024
New Synthetic Biomarker Technology Differentiates Between Prior Zika and Dengue Infections

Until now, researchers and clinicians have lacked diagnostic tools to easily differentiate between past infections with different flaviviruses—a family of mostly mosquito- and tick-borne viruses that include Zika and dengue. This challenge has hindered clinical-epidemiologic studies, viral diagnostics, and vaccine development. Antibodies for Zika virus, a mosquito-borne virus that spread to the Americas in 2015 and continues to cause sporadic outbreaks, can often be mistaken for dengue virus antibodies in many diagnostic tests. This confusion makes it difficult to determine if a person who tests positive had dengue, Zika, or both. For reproductive-age women, it is particularly crucial to know if they have had Zika and likely have immunity since infection during pregnancy can lead to birth defects. Knowing their immunity status can guide their efforts to avoid mosquito bites in endemic areas during pregnancy. Now, a newly discovered Zika virus-specific synthetic molecule can distinguish Zika-immune patient samples from those ...
- Source: drugdu
- 92
- May 16, 2024
New Respiratory Syndromic Testing Panel Provides Fast and Accurate Results

Respiratory tract infections are a major reason for emergency department visits and hospitalizations. According to the CDC, the U.S. sees up to 41 million influenza cases annually, resulting in several hundred thousand hospitalizations and as many as 51,000 deaths. Syndromic testing systems have improved the detection of co-infections, thus reducing the need for further testing. These systems provide rapid results, enabling healthcare providers to make timely decisions and stop unnecessary antibiotic treatments when viral pathogens are identified, which helps reduce antibiotic use and supports responsible antimicrobial stewardship. A new respiratory syndromic testing panel now allows for the accurate diagnosis of respiratory infections and the detection of co-infections. This panel delivers results in about one hour and requires less than one minute of hands-on time, while providing easy access to cycle threshold (Ct) values and amplification curves. QIAGEN N.V. (Venlo, the Netherlands) has received clearance from the U.S. Food and Drug ...
- Source: drugdu
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- May 16, 2024
Results from FRONTIER 2 Trial Show Promise of Mim8 as a Potential Treatment for Hemophilia A

Don Tracy, Associate Editor In the Phase IIIa FRONTIER 2 trial, participants aged 12 years and older administered Mim8 showed significant and superior reduction of treated bleeding episodes. Novo Nordisk announced successful results from the Phase IIIa FRONTIER 2 trial, which evaluated the efficacy and safety of Mim8, a promising new treatment for hemophilia A. According to the company, this trial enrolled 254 participants over the age of 12 years to analyze the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment. The trial met its two primary endpoints, which were to demonstrate significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly administration of Mim8.1 “We are very pleased with the positive results from the FRONTIER 2 clinical trial. These data demonstrate the ability of Mim8 to prevent bleeding episodes effectively and safely in people with ...
- Source: drugdu
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- May 16, 2024
AbbVie, Gilgamesh Pharmaceuticals Agree to Terms on a Collaboration to Develop Advanced Therapies for Psychiatric Disorders

The joint venture aims to address unmet needs in the treatment of mood and anxiety disorders through novel neuroplastogens.AbbVie and Gilgamesh Pharmaceuticals have announced a partnership focused on the development of therapies for psychiatric disorders. The collaboration seeks to leverage AbbVie’s experience in psychiatry and Gilgamesh’s research platform that focuses on neuroplastogens, which works to treat psychiatric conditions while minimizing adverse effects attributed to psychedelic compounds. According to the companies, the overall goal is to provide new opportunities in areas that haven’t provided manysolutions for patients with mood and anxiety disorders through the use of neuroplastogens. Under terms of the deal, AbbVie is expected to focus on future development and commercialization activities, while Gilgamesh will receive $65 million as an upfront payment. Upon the completion of specific milestones, including option fees and tiered royalties on net sales, Gilgamesh could potentially receive up to $1.95 billion.1 “Significant unmet need remains for ...
- Source: drugdu
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- May 16, 2024

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