PharmaFocus Today – Page 59 – 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 VinluanA 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 its ...
- Source: drugdu
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- August 10, 2024
Novartis’ kidney disease drug Fabhalta receives US FDA approval

Novartis announced that the US FDA has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g (1). Fabhalta specifically targets the alternative complement pathway of the immune system. When overly activated in the kidneys, the complement system is thought to contribute to the pathogenesis of IgAN (1-4). This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study measuring reduction in proteinuria at 9 months compared to placebo. It has not been established whether Fabhalta slows kidney function decline in patients with IgAN. The continued approval of Fabhalta may be contingent upon verification and description of clinical benefit from the ongoing Phase III APPLAUSE-IgAN study, evaluating whether Fabhalta slows disease ...
- Source: drugdu
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- August 10, 2024
DCGI waives off local trials for drugs approved in well-regulated markets

The CDSCO, with approval from the Central government, has notified a list of countries under rule 101 of the New Drugs and Clinical Trial Rules, 2019 that would, subject to conditions, consider the waiver of local clinical trials for several drugs if already approved in well-regulated markets. The countries on the list include the US, UK, Japan, Australia, Canada and the European Union. The categories of new drugs specified are: • Orphan drugs for rare diseases • Gene and cellular therapy products • New drugs used in pandemic situation • New drugs used for specific defence purpose • New drugs having significant therapeutic advance over the current standard care The move is expected to accelerate access to innovative therapies within the country. Lauding the decision, Anil Matai, Director General, OPPI, says that this move will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating ...
- Source: drugdu
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- August 10, 2024
New Technique Identifies Pathological Abnormalities Associated with Motor Neuron Disease

Motor neuron disease (MND), also referred to as amyotrophic lateral sclerosis (ALS), is a debilitating condition where messages from the brain’s motor neurons fail to reach the muscles, resulting in muscle weakening. At present, there is no cure for MND. Now, researchers have developed a new imaging technique to detect pathological abnormalities linked to MND, which could enhance the understanding of brain changes responsible for the disease and potentially aid in developing new treatments. This advancement was highlighted in a study published in Nature Communications, a collaborative effort between the University of Birmingham (Birmingham, UK) and the University of Sheffield (Sheffield, UK). Researchers at the University of Birmingham developed the new method called native ambient mass spectrometry (NAMS), allowing them to analyze proteins in their natural state directly from brain and spinal cord tissue samples. This technique provides unprecedented detail in studying protein structures in relation to their location within ...
- Source: drugdu
- 59
- August 10, 2024
3D Pathology with AI to Enhance Prognosis Accuracy for Barrett’s Esophagus Patients

Barrett’s esophagus is a condition where the lining of the esophagus changes due to chronic gastroesophageal reflux. Individuals with Barrett’s esophagus are at a slightly increased risk of developing esophageal cancer and require regular surveillance endoscopies. During these procedures, gastroenterologists collect numerous biopsies from the affected tissues. These samples are then cut into thin sections and placed on glass slides for examination under a microscope by pathologists. However, the tissue sections that pathologists view represent only about 1% or less of the actual biopsies and provide just a two-dimensional view, which can be misleading. Researchers are now conducting clinical studies of archived tissues from patients with the condition to develop computational 3D pathology methods for Barrett’s esophagus risk stratification. The research team at UW College of Engineering (Seattle, WA, USA) had previously invented 3D pathology methods to assess prostate cancer risk and shifted their focus on gastrointestinal applications of their ...
- Source: drugdu
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- August 10, 2024
Prostate Cancer Blood Test Found Equally Effective Across Ethnic Groups

Stockholm3, a prostate cancer test that analyzes a combination of protein and genetic markers from a blood sample using an algorithm, has been shown to predict the likelihood of clinically significant cancer with greater accuracy than the conventional prostate-specific antigen (PSA) test. Research involving over 90,000 men indicates that Stockholm3 outperforms PSA, helping to avoid unnecessary MRIs and biopsies, and identifying serious cancers even in men with low or normal PSA levels. Historically, these studies primarily involved a predominantly White Scandinavian population, casting doubt on their applicability globally. Now, a new study has confirmed that Stockholm3 is equally effective across diverse ethnic backgrounds and continues to outperform the PSA standard significantly. The study, conducted by researchers at Karolinska Institutet (Stockholm, Sweden) where the Stockholm3 blood test was developed, involved more than 2,000 men from 17 clinics, with ethnic backgrounds including 16% Asian, 24% African-American, 14% Latin American, and 46% White ...
- Source: drugdu
- 69
- August 9, 2024
New Visual Diagnostic Technique to Advance Early Detection of Neurodegenerative Diseases

Parkinson’s disease is identified by the buildup of misfolded alpha-synuclein proteins, which are crucial to the function of neural cells in the brain. This condition impacts millions globally, creating substantial hurdles in both early detection and treatment. Typically, Parkinson’s is diagnosed in later stages through clinical observation of physical symptoms, which often delays the application of potential treatments. Early diagnosis currently depends on sophisticated, costly equipment that is not widely accessible, particularly in less developed regions. Researchers have now introduced a novel visual diagnostic approach aimed at improving early detection capabilities for neurodegenerative diseases like Parkinson’s. Named Cap-QuIC (Capillary-enhanced Quaking-Induced Conversion), the techniques developed by researchers at the University of Minnesota (Minneapolis, MN, USA), allows clinicians to visually identify infected samples, enhancing both the affordability and accessibility of testing. Building on their earlier diagnostic advancements, Cap-QuIC employs a simple technique to visually detect misfolded alpha-synuclein proteins. In their research published ...
- Source: drugdu
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- August 9, 2024
China moves to advance high-quality development of service consumption

China will work to further develop consumer services to support high-quality economic development and meet people’s demand for personalized, diversified and quality services, according to a guideline made public Saturday. The guideline, issued by the State Council, set out 20 key tasks, including tapping the potential of consumption in sectors such as hospitality, domestic services, elderly care, childcare, entertainment, tourism, sports, education and training. It also pledged to foster new types of consumption like digital, green and health services, create new consumption scenarios, relax market access, strengthen regulation and provide more policy support for service consumption. China will continue to open up sectors such as telecommunications, education, elderly care and medical care, and ensure the implementation of opening-up measures in areas like technology services and tourism, according to the document. The country will also optimize entry policies and consumption environments, speed up the resumption of flights, provide diversified payment services, ...
- Source: drugdu
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- August 9, 2024
Chinese CAR-T Pioneer Legend Biotech in Profile

Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the company has remained uniquely focused on CAR-T cells targeting the BCMA protein. Humble Beginnings and a Breakthrough Approval Back in 2014, a team of Chinese scientists began investigating cell therapies for cancer under the banner of the “Legend Project,” operating in what the company calls “a room the size of a freight elevator.” After making the decision to focus its research solely on chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein in 2015, Legend began conducting its first clinical trials in 2016. The pioneering biotech landed its first major vote of confidence from the global life sciences community in 2017, ...
- Source: drugdu
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- August 9, 2024
Janssen’s psoriasis drug shows promise for childhood diabetes

A new study led by researchers from Cardiff University, King’s College London (KCL), Swansea University and the University of Calgary has revealed that Janssen’s psoriasis drug, Stelara (ustekinumab), shows promise in treating childhood diabetes. Published in Nature Medicine and funded by a Medical Research Council and National Institute for Health and Care Research partnership, the study found that Stelara was more effective in treating the early stages of type 1 diabetes (T1D) in children and adolescents. Accounting for approximately 10% of diabetes cases in the UK, T1D occurs when the pancreas does not produce insulin or makes very little insulin. Since 2009, the immunotherapy Stelara has been used to treat psoriasis, a skin condition characterised by flaky patches of skin that affects around 60 million people globally, as well as other immune conditions, including psoriatic arthritis, severe Crohn’s disease and severe ulcerative colitis. In the study, researchers tested Stelara in ...
- Source: drugdu
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- August 9, 2024

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