PharmaFocus Today – Page 56 – media

Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank Vinluan A Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize ...
- Source: drugdu
- 72
- August 8, 2024
Luye Pharma’s Dual TAAR1/5-HT2CR Agonist LY03020 Approved for Clinical Trials in China

Luye Pharma Group today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for LY03020 filed under the Class 1 pathway for investigational drugs. LY03020, a dual TAAR1/5-HT2CR agonist, is intended to treat schizophrenia and Alzheimer’s disease psychosis (ADP). Developed on Luye Pharma’s New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, LY03020 is a next-generation antipsychotic and the first agonist against both the trace amine-associated receptor 1 (TAAR1) and the 5-HT2C receptor (5-HT2CR) in the world. “Unlike the existing antipsychotics that typically antagonize D2 and 5-HT2A receptors on the postsynaptic membrane, the next-generation antipsychotics agonize those receptors on the presynaptic membrane. Compared with the existing antipsychotics, LY03020 targets both TAAR1 and 5-HT2CR, and thus is able to reduce adverse reactions such as extrapyramidal symptoms (EPS) and metabolic syndromes while significantly improving the negative symptoms and cognitive impairments ...
- Source: drugdu
- 75
- August 8, 2024
Buyout of China’s drug companies by global pharma giants sparks national security fears

Chinese pharmaceutical industry insiders have warned that foreign takeovers may damage the sector and even threaten national security. Since December, five Chinese biotech drug makers have been sold to global pharmaceutical giants. Industry insiders have warned that this could have a negative impact, especially given the risk that the United States could extend its technology sanctions to essential medicines. John Cai, chairman of China Healthcare Innovation Platform Academy, a healthcare think tank in Shanghai, said: “When national conflicts occur and drugs are sanctioned as strategic products, it will affect the health of a country’s population. “Considering that China’s biopharmaceutical and broader healthcare industry are now facing international competition and restrictions, Beijing should act with a sense of urgency.” He also said that research and development was a long process and if innovative products were sold as soon as they were developed, it would be difficult for China to cultivate world-class ...
- Source: drugdu
- 62
- August 8, 2024
BHF’s HIF funds five heart research projects over £800,000

The British Heart Foundation (BHF) has awarded five research projects more than £800,000 as part of its Healthcare Innovation Awards to improve the delivery of vital healthcare for patients. Comprising artificial intelligence (AI) and stethoscopes to offer digital access to mental health services to those living in remote areas, the projects will receive between £100,000 and £300,000 via the Healthcare Innovation Fund (HIF). Cardiovascular diseases (CVD) affect around seven million people in the UK, including coronary heart disease, the most common form of heart and circulatory disease, which affects around 2.3 million people in the UK. The HIF supports research that aims to explore and improve existing services and care for people living with heart conditions across the UK. Researchers from Imperial College London, Hull York Medical School, Leicester University Hospital, Jubilee University National Hospital and the University Hospital of Wales have been selected to receive the funding. The research ...
- Source: drugdu
- 58
- August 8, 2024
Researchers reveal brain parasites could be used to treat cognitive disorders

Researchers from the University of Glasgow, in collaboration with Tel Aviv University, along with international researchers, have revealed that brain parasites could be used to deliver drugs to the brain to treat cognitive disorders. In the study published in Nature Microbiology, researchers explored whether the common brain parasite Toxoplasma gondii could be used to deliver treatment across the blood-brain barrier, a major complication for the treatment of many neurological conditions. According to a study published in the Lancet Neurology in March and funded by the Bill & Melinda Gates Foundation, neurological conditions are considered the leading cause of ill health worldwide, with stroke, neonatal encephalopathy, migraine, Alzheimer’s disease (AD) and other dementias, and diabetic neuropathy being the biggest global contributors. Researchers engineered Toxoplasma gondii parasites to deliver the MeCP2 protein, a therapeutic protein that has been dubbed a promising target for Rett syndrome, a debilitating neurological disorder caused by mutations in ...
- Source: drugdu
- 61
- August 8, 2024
New AI Protocol Instantaneously Detects Cancer Genomic Biomarkers Directly from Tumor Biopsy Slides

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 ...
- Source: drugdu
- 85
- August 7, 2024
Highly Accurate Blood Test Detects Pancreatic Cancer Early in At-Risk Patients

Pancreatic ductal adenocarcinoma (PDAC), the most prevalent type of pancreatic cancer, is highly lethal but can potentially be cured with surgery and modern treatments. There is a pressing need for a simple, quick, and accessible blood test to diagnose pancreatic cancer early in at-risk individuals. Now, a new pancreatic cancer detection test offers significantly improved accuracy, fulfilling this need and potentially boosting survival rates for these patients. Immunovia AB (Lund, Sweden) has reported enhanced outcomes for its next-generation test aimed at detecting early-stage PDAC in high-risk individuals. In April 2024, the company shared positive outcomes from the preliminary model-development study of its innovative pancreatic cancer detection test. This study incorporated 624 patient samples collected from 13 distinct clinical sites, including 129 samples from patients diagnosed with stage 1 or 2 PDAC and 495 control samples, primarily from individuals at elevated risk for hereditary and/or familial pancreatic cancer. The control group ...
- Source: drugdu
- 79
- August 7, 2024
FDA Approves Expanded Indication for Octapharma’s Fibryga for Patients Experiencing Bleeding Due to Acquired Fibrinogen Deficiency

By Don Tracy, Associate Editor Expanded indication makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.The FDA has approved an expanded indication for Octapharma’s Fibryga, a lyophilized human fibrinogen concentrate now indicated for patients experiencing bleeding due to acquired fibrinogen deficiency (AFD). According to the company, this approval marks a significant advancement over cryoprecipitate, the current standard of care, by providing a faster and more precise treatment option for severe bleeding episodes. Additionally, the regulatory action makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.1 “In the surgical theater, time matters. And confidence matters. This expanded FDA approval of fibryga represents a major step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option for providers who must act urgently,” said Flemming Nielsen, president, Octapharma USA, ...
- Source: drugdu
- 87
- August 7, 2024
Bayer Looks to Expand Kerendia’s Label to Heart Failure After Phase 3 Win

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 ...
- Source: drugdu
- 68
- August 7, 2024
University of Hong Kong creates app to detect heart valve diseases by checking chest sounds

The University of Hong Kong has developed a mobile app for members of the public to detect heart valve diseases, with researchers hoping the innovation can help prevent delays in diagnosing and treating such conditions. A clinical study involving more than 350 patients found accuracy levels for the artificial intelligence-based software were as high as 81 per cent, close to those achieved by cardiologists using stethoscopes. Such diseases can occur when heart valves fail to open and close properly, resulting in abnormal blood flow. Symptoms include shortness of breath, dizziness and swollen feet. Professor Joshua Ho Wing-kei of the university’s biomedical sciences school noted on Wednesday that life-threatening heart valve diseases currently affected about 10 per cent of the world’s population above the age of 70. “Valvular heart disease is often hidden and many only seek medical help when their condition has become serious,” he said. “We hope patients can ...
- Source: drugdu
- 74
- August 7, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.