PharmaFocus Today – Page 101 – media

Ionis and Biogen discontinue experimental ALS drug after Phase I/II flop

Ionis and Biogen are halting the development of their experimental treatment for amyotrophic lateral sclerosis (ALS) after it failed to show improvement in patients in a Phase I/II study. Data from the 99-patient ALSpire study (NCT04494256) demonstrated that BIIB105 failed to significantly reduce neurodegeneration or improve functional measures such as breathing. BIIB105, an investigational antisense oligonucleotide was designed to reduce the expression of ataxin-2 (ATXN2) protein. Despite demonstrating statistically significant ATXN2 reductions in the study, the drug showed no evidence of clinical benefit in any subgroup evaluated in the study. This marks another setback in the search for new treatments for ALS, a progressive neurodegenerative disease that causes muscle weakness and paralysis. Last month, Amylyx Pharmaceuticals axed its ALS drug Relyvrio (AMX0035) from the market after its Phase III Phoenix trial failed to meet any of its endpoints. However, this trial failure does not mark the end of Ionis and ...
- Source: drugdu
- 105
- May 20, 2024
Roche targets obesity market with early positive trial data

Roche is looking to share in the windfall from the sales in obesity therapies as it announces positive results from the Phase Ib trial of its investigational obesity and type 2 diabetes (T2D) therapy. CT-388 is a once-weekly subcutaneous dual glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist. It selectively targets two incretin receptors that control food intake, energy absorption and assimilation. The therapy has a similar mechanism of action as Eli Lilly’s Mounjaro (tirzepatide), which generated $1.81bn in sales in Q1 this year, according to Lilly’s financials. Following today’s news, the Swiss company’s share was up by over 3.5% in trading today on the Swiss stock market. Roche’s market cap is SFr190.6bn ($210.8bn). The placebo-controlled Phase Ib trial (NCT04838405) enrolled approximately 96 overweight or obese participants with or without T2D. The participants in the CT-388 group achieved a mean placebo-adjusted weight loss of 18.8% at 24 ...
- Source: drugdu
- 108
- May 20, 2024
Ultrasound-Aided Blood Testing Detects Cancer Biomarkers from Cells

Ultrasound imaging serves as a noninvasive method to locate and monitor cancerous tumors effectively. However, crucial details about the cancer, such as the specific types of cells and genetic mutations involved, typically require invasive biopsies, which can cause harm. Now, a research team has developed a new method to utilize ultrasound for gently extracting this genetic information. Researchers at the University of Alberta (Edmonton, AB, Canada) have been investigating the use of intense ultrasound in releasing biological indicators of disease, or biomarkers, from cells. These biomarkers include elements like miRNA, mRNA, DNA, and various genetic mutations, all of which are critical for identifying the cancer type and guiding treatment decisions. The ultrasound technique releases these biomarkers from the cells into the bloodstream, where they reach concentrations high enough to be detected. This enables oncologists to identify and track the cancer’s status or response to treatment through blood samples instead of ...
- Source: drugdu
- 91
- May 17, 2024
New DNA Origami Technique to Advance Disease Diagnosis

DNA origami is a method used to create nanostructures with exceptional precision, utilizing DNA strands as the foundational building blocks. These structures, however, are inherently fragile and prone to disintegration under biological conditions, such as fluctuations in temperature or the presence of certain enzymes in living organisms. To address this vulnerability, researchers have now devised an innovative method to both customize and strengthen DNA origami, offering the potential to advance drug delivery and disease diagnostics. A team of scientists from the universities of Portsmouth (Portsmouth, UK) and Leicester (Leicester, UK) has pioneered a novel approach to reinforce these origami structures, making them both stronger and more adaptable through a process they call triplex-directed photo-cross-linking. This technique involves the strategic addition of new nucleotide sequences to the DNA during the design phase. These sequences are the basic building blocks of DNA and act as attachment points for functional molecules, enhancing the ...
- Source: drugdu
- 89
- May 17, 2024
Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
- Source: drugdu
- 77
- May 17, 2024
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
- 80
- 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
- 75
- 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
- 114
- May 17, 2024

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