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Pfizer touts positive topline data for RSV vaccine Abrysvo

Pfizer has announced positive topline results from a pivotal late-stage study of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults who are immunocompromised and at risk of developing severe RSV-associated lower respiratory tract disease (LRTD). As per the 12 August press release, Abrysvo was found to be well tolerated in the substudy B portion of the pivotal Phase III MONeT study (NCT05842967). While substudy B evaluated two 120 µg dose doses of Abrysvo, Pfizer reported that a single 120 µg dose of the vaccine led to “strong neutralizing” responses against RSV-A and RSV-B. The safety profile of Abrysvo was consistent with that of previous studies. “Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said senior vice president and CSO, Vaccine ...
- Source: drugdu
- 74
- August 14, 2024
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
- Source: drugdu
- 92
- August 14, 2024
【EXPERT Q&A】How to apply for the management record of Class II medical devices?

Drugdu.com expert’s response: The application process for the Class II medical device operation registration mainly involves the following steps: Ⅰ. Prepare Registration Materials 1.Enterprise Qualification Documents: Copy of the enterprise’s business license, certifying its legal business qualifications. 2.Organization code certificate (if applicable), verifying the enterprise’s organization code. 3.dentity cards, educational background, or professional title certificates of the enterprise’s legal representative or person in charge, and quality managers, to verify the identity and qualifications of relevant personnel. 4.Quality Management Personnel and Professional Technical Personnel Information: Work resumes of quality management personnel. 5.A list of professional technical personnel, along with their identity cards, educational certificates, and professional title certificates, to demonstrate the enterprise’s quality management capabilities and professional technical proficiency. 6.Business Premises and Warehouse Information: Geographical location maps and floor plans of the enterprise’s business premises and warehouse addresses, as well as commercial property ownership certificates, red lease contracts, or site usage certificates, to prove ...
- Source: drugdu
- 107
- August 14, 2024
Blood Test Predicts Chronic Lung Disease in Preterm Babies

Bronchopulmonary dysplasia (BPD) is a condition that impacts 65% of preterm infants, leading to chronic lung disease and neurodevelopmental impairments that persist throughout life. BPD typically arises when premature infants require respiratory support and prolonged oxygen therapy, which can damage their developing lungs. Currently, options for predicting, preventing, and treating BPD are inadequate. Diagnoses are often not confirmed until 36 weeks post-menstrual age, delaying interventions that could reduce lung damage and enhance respiratory health. Existing early prediction tools do not effectively address the underlying pathology of the disease. However, timely lung protective measures can modify BPD incidence. More precise care could be administered if the likelihood of lung damage and other complications in these infants were known sooner. Researchers have now developed a blood test that can predict which preterm infants will go on to develop chronic lung disease, facilitating earlier intervention and more focused treatment strategies. The research, led ...
- Source: drugdu
- 74
- August 13, 2024
Saliva Test More Accurately Indicates Severity of Recurrent Respiratory Infections in Children

Approximately 10-15% of children experience recurrent respiratory infections, prompting hospital visits where blood tests are commonly performed to check for antibody deficiencies. Yet, these tests often fail to provide helpful insights. There is a pressing need for alternative methods that better assess the severity of the condition, which would aid in determining when increased care or antibiotic treatment is necessary. Now, new research reveals that saliva testing might offer a more accurate reflection of the severity of recurrent respiratory infections in children compared to traditional blood tests. If saliva contains too few broadly protective antibodies, there is a higher likelihood of pneumonia episodes for the children. The collaborative study by researchers at Radboudumc Amalia Children’s Hospital (Nijmegen, Netherlands) and UMC Utrecht Wilhelmina Children’s Hospital (Utrecht, Netherlands) involving 100 children with recurrent respiratory infections found that saliva tests are better indicators of disease severity than blood tests. The study demonstrated no ...
- Source: drugdu
- 79
- August 13, 2024
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
- 58
- 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
- 90
- 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
- 81
- 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
- 82
- August 13, 2024

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