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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
- 95
- February 22, 2024
ASTRUM-004 Featured on the Cover of Cancer Cell

On February 12, 2024, the Volume. 42 Issue. 2 of Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3, was published online. ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was highlighted on the front cover of the issue. This marks the first time a clinical study of an innovative Chinese drug has been featured on the journal’s cover in its 22-year history. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. “Zhou et al. report the results of a phase 3 trial that demonstrates the efficacy and safety of serplulimab plus chemotherapy as first-line treatment for patients with advanced squamous non-small-cell lung cancer (sqNSCLC).” The editors highly commended ASTRUM-004 and the cover design. “The cover features a collage of pathology slices ...
- Source: drugdu
- 160
- February 22, 2024
Hengrui Medical made a new breakthrough in the field of medical nuclide preparation and successfully prepared 64Cu in batch.

Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs. In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for ...
- Source: drugdu
- 140
- 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
- 116
- 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
- 164
- 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
- 197
- 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
- 199
- 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
- 168
- 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
- 142
- 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
- 174
- February 21, 2024

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