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FDA Approves First Epinephrine Nasal Spray for Type I Allergic Reactions Including Anaphylaxis

By Don Tracy, Associate Editor Approval of neffy marks a significant advancement in epinephrine delivery, offering a less painful alternative to traditional needle injections.The FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray), a first-in-class needle-free, nasal spray treatment for type I allergic reactions, such as anaphylaxis, for adults and children weighing 66 lbs. or more. According to the company, this approval offers a less painful alternative to traditional needle injections, which are often delayed due to anxiety, potentially worsening allergic reactions.1 “Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option—an often painful and anxiety-inducing needle injection of epinephrine. In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment,” said Thomas B. Casale, MD, professor of medicine, pediatrics, and chief of clinical and ...
- Source: drugdu
- 56
- August 13, 2024
An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs

The White House might soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. By Katie AdamsThe White House could soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. Typically, when patients receive copay assistance from pharmaceutical companies, the amount paid by the manufacturer helps reduce the patient’s out-of-pocket costs. But with copay accumulators, the assistance from the drugmaker is not counted toward the patient’s maximum limit on out-of-pocket expenses. In September of last year, Judge John D. Bates of the U.S. District Court for the District ...
- Source: drugdu
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- August 13, 2024
ARS Pharmaceuticals’ anaphylaxis nasal spray gains FDA approval

The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals‘ neffy (epinephrine nasal spray) 2mg for the emergency treatment of allergic reactions (type I). The indications include life-threatening anaphylaxis in adults and children weighing a minimum of 30kg. Previously, only injectable epinephrine was available for such patients. Anaphylaxis is a severe allergic reaction that can quickly become fatal, necessitating immediate medical intervention. Common triggers include certain foods, medications and insect stings, with symptoms such as hives, swelling, and difficulty breathing typically manifesting within minutes of exposure. The approval of neffy is supported by data from four clinical studies involving 175 healthy adults. These studies compared the blood concentration levels of epinephrine after administering neffy or traditional epinephrine injections. The findings indicated that neffy delivers comparable epinephrine levels to those of injectable products. In addition to matching the epinephrine blood concentrations, neffy demonstrated similar increases in blood pressure and heart ...
- Source: drugdu
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- August 13, 2024
Sable Therapeutics and Columbia sign deal on obesity treatments

Sable Therapeutics has entered into an exclusive global licensing agreement with Columbia University to develop new polycation nanomedicines aimed at treating obesity. This partnership will focus on progressing a portfolio of compounds, SBL-001 and SBL-002, targeting both visceral and subcutaneous adiposity. Sable will hold sole rights for the development and commercialisation of the intellectual property created by Columbia University’s Dr Kam Leong, biomedical engineering professor Samuel Sheng, and Sable Therapeutics scientific co-founder Dr Li Qiang. SBL-001 and SBL-002 are designed to significantly diminish fat cell volume and have been uniquely engineered for selective uptake by adipose cells. Key features of the compounds include the ability to reduce fat cell targeted uptake volume by up to 70%. They can also act as a discrete drug delivery system for other agents, such as GLP-1s, which reduce fat. Sable Therapeutics focuses on creating assets for fat reduction, targeting conditions such as visceral obesity ...
- Source: drugdu
- 64
- August 13, 2024
KCL and UCL scientists develop accurate AI brain imaging model for research

Researchers from King’s College London have developed a new artificial intelligence (AI) brain imaging model in collaboration with University College London (UCL) which is realistic and accurate enough to use in medical research. Published in Nature Medicine Intelligence, the three-dimensional, synthetic images of the human brain could help support research to predict, diagnose and treat brain diseases including dementia, stroke and multiple sclerosis. According to Brain Research UK, there are an estimated 11 million people in the UK who are living with a neurological condition. Among the most common are Alzheimer’s disease, epilepsy and stroke. In collaboration with the London Medical Imaging and AI Centre for Value-Based Healthcare and NVIDIA data scientists and engineers, researchers trained the AI model in weeks as opposed to months using the NVIDIA Cambridge-1 supercomputer. The model is able to produce 3D, high-resolution images that have all the characteristics of real human brains, including correct ...
- Source: drugdu
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- August 13, 2024
Study reveals genetic variants are more common in Parkinson’s disease patients

A US study supported by the Parkinson’s Foundation has revealed that genetic variants associated with Parkinson’s disease (PD) are more common than researchers previously thought. The PD GENEration study published in the journal Brain has been testing for clinically relevant PD-related genes while providing genetic counselling at no cost for people living with the condition since 2019, and recently reached a recruitment milestone of more than 15,000 patients. PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. Results from the first 3.5 years of the study showed that 13% of patients have a genetic form of PD and revealed that positivity rates for a genetic variant were significantly higher for individuals at high risk of developing PD. Those with early-onset PD, high risk-ancestry such as Ashkenazi Jewish, Spanish Basque, or North African Berber, or with first-degree relatives affected ...
- Source: drugdu
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- August 13, 2024
【EXPERT Q&A】What are Indonesia SAS certification, SNI certification and LS certification respectively?

Drugdu.com expert’s response: The Indonesian SAS, SNI, and LS certifications are different certification systems in Indonesia that cater to various industries and product types. Below is a detailed introduction to each: Ⅰ. Indonesian SAS Certification 1.Definition and Background: The SAS certification is a “Special Access Scheme” established by the Indonesian government in response to emergencies such as the COVID-19 pandemic. It allows the government to directly import urgently needed medical devices without first obtaining an import distribution license. This policy was announced by the Indonesian Ministry of Health through its official website, aiming to expedite the registration and approval process for critical medical equipment during emergencies such as pandemics. 2.Applicable Products: The SAS certification primarily targets medical devices that are urgently needed in Indonesia, including surgical gowns (including masks, personal protective equipment, medical goggles), liquid chemical disinfectants (including disinfectants, hand sanitizers), surgical gloves, patient examination gloves, clinical electronic thermometers, respirators, etc. 3.Application ...
- Source: drugdu
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- August 12, 2024
First Patient Dosed of Phase 2 Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein in Combination with Serplulimab Plus HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fifth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in 2022. From which, hepatocellular carcinoma (HCC) is the predominant pathological type of PLC, which accounts for between 75% and 85% of liver cancer cases. Due to its insidious onset, lack of symptom in its early stage, and quick progression, PLC usually has ...
- Source: drugdu
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- August 12, 2024
First Patient Enrolled in the US Phase 2 Combination Therapy of Akeso’s Ligufalimab with Azacitidine for Myelodysplastic Syndrome

Akeso has announced the completion of the first patient enrollment in the US for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). Preliminary studies show that combining AK117 with azacitidine for treating MDS is safe and significantly effective. In response to the urgent need for new therapies among global MDS patients and the evolving market landscape, Akeso has launched an international multicenter Phase II clinical trial. This initiative aims to expedite AK117’s global approval and commercialization process. CD47-targeted drug development for treating MDS shows promising potential. AK117, a next-generation humanized IgG4 anti-CD47 antibody, effectively blocks the CD47-SIRPα interaction to enhance phagocytic activity against tumor cells by phagocytes. Recent data presented at the 65th American Society of Hematology (ASH) Annual Meeting demonstrated that AK117 combined with azacitidine significantly reduces anemia and transfusion requirements ...
- Source: drugdu
- 85
- August 12, 2024
Computational protocol provides cheaper route to manage cholesterol levels

Researchers led by Dr Suman Chakrabarty from S N Bose National Centre for Basic Sciences, Kolkata, an autonomous institute under the Department of Science and Technology, in collaboration with Sarfez Pharmaceuticals, have explored a new frontier in computer-aided drug discovery that can help develop medicines that can prevent harmful protein-protein interactions which can lead to conditions like elevated low-density lipoprotein (LDL) or cholesterol level. Traditionally, scientists have tried to develop small molecules as drugs that would preferentially bind to the protein-protein interaction (PPI) sites and act as competitive inhibitors. However, finding drugs that can effectively block these protein interactions has been difficult because the areas where proteins interact are often large and smooth, with no clear spots for a drug to latch onto. A commonly used alternative approach is to use large peptides or antibodies to inhibit PPIs. But these are often undesirable due to the increased cost, difficulty of ...
- Source: drugdu
- 69
- August 12, 2024

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