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Recombinant Herpes Zoster Vaccine Independently Developed by Shanghai Institutes for Biological Products of China Receives Clinical Trial Approval Notice

On February 20, the recombinant herpes zoster vaccine, a Class I new drug independently developed by Shanghai Institutes for Biological Products of China, received a notice of approval for clinical trial from the State Drug Administration. Herpes zoster is a common viral infectious disease caused by the reactivation of varicella-zoster virus latent in the human sensory ganglia, with severe nerve pain and skin herpes as the main symptoms. According to relevant data, there are about 1.56 million new cases of herpes zoster in people aged 50 years and above every year in China. Herpes zoster and its complications seriously affect the work and life of patients. Vaccination against herpes zoster is an important measure for the prevention of herpes zoster and postherpetic neuralgia, but at present there are limited varieties of herpes zoster vaccine available in China. Shanghai Institutes for Biological Products (SIBI) has independently developed a recombinant herpes zoster ...
- Source: drugdu
- 87
- February 22, 2024
Spit Test Detects Breast Cancer in Five Seconds

Breast cancer is the most commonly diagnosed cancer worldwide, with over 2.3 million new cases and approximately 685,000 deaths reported in 2020. Currently, mammography, ultrasound, MRI, and biopsies are the primary methods for diagnosing breast cancer. Despite their effectiveness, these techniques have several drawbacks, such as high costs, limited accessibility, potential inaccuracies in early detection in young women with dense breast tissue, invasiveness, and radiation exposure risks, especially for radiation-sensitive patients. Given the increasing prevalence of breast cancer in women, there is an urgent need for more innovative and efficient detection methods. Now, a saliva test that screens for breast cancer is showing promising results in experimental testing. Developed collaboratively by researchers from the University of Florida (Gainesville, FL, USA) and National Yang Ming Chiao Tung University (Hsinchu City, Taiwan), this innovative hand-held device can detect breast cancer biomarkers using just a small saliva sample. The device operates by applying ...
- Source: drugdu
- 103
- February 21, 2024
Accurate Blood Test for Detecting Malignant Brain Tumors Could Help Patients Avoid Risky Surgery

Globally, brain tumors comprise 85%-90% of all primary central nervous system (CNS) tumors, representing approximately 300,000 cases (1.6%) out of the total 19,300,000 annual cancer incidences. They also account for around 250,000 (2.5%) of the total 10,000,000 annual cancer-related deaths. Presently, the standard of care (SoC) for diagnosing intracranial space-occupying lesions (ICSOL) involves histopathological evaluation (HPE) of tumor tissue specimens, which are typically obtained through surgical excision or biopsy. However, surgical resection or biopsy can be particularly challenging for patients with poor performance status, comorbidities, or reluctance to undergo invasive procedures. These procedures carry well-documented risks, including pain, discomfort, intracranial hemorrhage, cerebral edema, infections, and even morbidity and mortality. Now, a simple blood test could help diagnose patients with brain tumors, saving them from undergoing invasive, highly risky surgery. In a world-first, researchers at Imperial College London (London, UK) have proved a new technique for glial tumors including glioblastoma (GBM), ...
- Source: drugdu
- 158
- February 21, 2024
FDA Grants Accelerated Approval to Iovance’s Amtagvi for Unresectable or Metastatic Melanoma

Davy James Amtagvi (lifileucel) becomes the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer. Image credit: Christoph Burgstedt | stock.adobe.com The FDA has granted accelerated approval to Iovance’s Amtagvi (lifileucel) for adults with unresectable or metastatic melanoma who received prior treatment with a PD-1 antibody, and in patients who are BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor. The regulatory action makes Amtagvi the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer. “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited ...
- Source: drugdu
- 182
- February 21, 2024
How Digitizing Data Collection and Analysis in Biopharma Can Drive Better, Faster Insights

Moving from spreadsheets to automated data collection and processing is far from easy, but it could revolutionize drug development. It’s time for the biopharma industry to embrace end-to-end digitalization. By UNJULIE BHANOT When it comes to collecting and analyzing data, many biopharma companies are still in the digital dark ages. They process data using tools such as Microsoft Excel, which has a lot of capabilities but isn’t tailored to biopharma. Those that do undergo a digital transformation often install fragmented software tools that generate data in silos, requiring a lot of manpower to consolidate, format and chart the data. This is a laborious process that involves manually collating and assimilating data from disparate systems. As the volume of data generated by the biopharma industry explodes, this fragmented approach simply won’t cut it. Imagine a room full of bioreactors generating process-monitoring data every minute, with cell culture sampling performed a number ...
- Source: drugdu
- 160
- February 21, 2024
FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight ...
- Source: drugdu
- 148
- February 21, 2024
MABWELL’s bio-iron homeostasis macromolecule regulatory drug 9MW3011 received FDA orphan drug designation

MABWELL (SHANGHAI) BIOSCIENCE CO. LTD. (688062.SH), an innovative biopharmaceutical company with a full industrial chain layout, announced that the U.S. FDA has granted orphan drug to the iron homeostasis macromolecule regulatory drug 9MW3011 (R&D code in the U.S.: MWTX-003/DISC-3405) (Orphan Drug Designation, ODD). 9MW3011 is indicated for the treatment of polycythemia vera (PV). Orphan drug designation from the FDA applies to drugs for rare diseases that affect fewer than 200,000 patients in the United States. Orphan drug designation can bring policy benefits to drug developers, including assistance during the drug development, clinical fee reductions, and seven years of market exclusivity after approval. 9MW3011 has been undergoing clinical trial in China and the United States and received FDA fast track designation in September last year. About 9MW3011 9MW3011 is an anti-TMPRSS6 monoclonal antibody independently developed by MABWELL’s San Diego Innovation R&D Center in the United States. It can upregulate the level ...
- Source: drugdu
- 122
- February 21, 2024
GSK’s Omjjara recommended by NICE to treat myelofibrosis patients with anaemia

GSK’s Omjjara (momelotinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for myelofibrosis-related splenomegaly or symptoms in adults with moderate-to-severe anaemia. The agency’s final draft guidance applies to both newly diagnosed and previously treated patients, although those eligible will need to have either not been treated with JAK inhibitors before or been treated with Novartis’ Jakavi (ruxolitinib). Estimated to affect more than 1,900 people in England, Wales and Northern Ireland, myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells. About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis and nearly all patients develop anaemia at some point over the course of their disease. Omjjara is a once-a-day oral JAK1/JAK2 and ACVR1 inhibitor that aims to address the key manifestations of the disease. NICE’s recommendation comes shortly after the Medicines and Healthcare ...
- Source: drugdu
- 153
- February 21, 2024
Daiichi Sankyo and AstraZeneca’s lung cancer antibody set for FDA review

It is shaping up to be a big year for AstraZeneca in lung cancer treatments. Following another approval win for its blockbuster immunotherapy drug Tagrisso (Osimertinib) in non-small cell lung cancer (NSCLC), another drug could be on the way later this year. The US Food and Drug Administration (FDA) has accepted for review Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy, as per a 19 February press release. The outcome of the FDA’s decision will only be known later this year, with a Prescription Drug User Free Act (PDUFA) date set for 20 December 2024. AstraZeneca and Daiichi Sankyo’s Dato-DXd is a TROP2-directed antibody-drug conjugate (ADC). TROP2 is a protein highly expressed in many types of lung cancers. The drug has demonstrated positive results in the Phase III TROPION-Lung01 ...
- Source: drugdu
- 135
- February 21, 2024
Health Executives Are Implementing Digital Health, But Aren’t Seeing ROI Yet

Following the Covid-19 pandemic, there has been a boom in the digital health space. But health executives aren’t seeing the financial benefits just yet, according to a recent survey from EY, a consulting firm. The online survey received responses from 101 healthcare executives in the U.S. It found that while 86% of health executives say that digital health solutions have the potential to reduce costs, 70% said they haven’t seen a return on investment so far. In addition, 50% of healthcare organizations say that “siloed tracking metrics” make it hard to follow tech’s initial cost value. “I think we’re still in the early innings of this digital transformation. The Covid episode introduced to the world of U.S. healthcare that, yes, I can interact with my physician remotely and so forth. … We got this first initial wave of incredible excitement and value, but there’s so much work to be done ...
- Source: drugdu
- 135
- February 20, 2024

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