Don Tracy, Associate Editor Dupixent has previously been approved for adults with chronic rhinosinusitis with nasal polyposis whose condition is inadequately controlled. Regeneron and Sanofi announced that the FDA has granted Priority Review to their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years who have chronic rhinosinusitis with nasal polyposis (CRSwNP) and whose condition is inadequately controlled. With the treatment already approved for adults with CRSwNP, the FDA is expected to make a final decision on the sBLA for the expanded indication by September 15, 2024.1 According to the companies, the application is supported by efficacy data from SINUS-24 and SINUS-52, two trials that showed major improvements in nasal congestion/obstruction severity, nasal polyp size, sense of smell, and a reduction in the need for systemic corticosteroids or surgery. In 2019, Regeneron first released the results of both trials, ...
Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
Dive Brief Outset Medical received 510(k) clearance for TabloCart with prefiltration, an accessory that filters sediment and minerals out of water before it enters the company’s dialysis machines. Outset stopped distributing the accessory last year after receiving a warning letter in July 2023 from the Food and Drug Administration stating that it needed 510(k) clearance. BTIG analyst Marie Thibault wrote in a research note that the clearance is a “big win” for Outset, adding that she expects the company to now be able to work through a customer backlog. Dive Insight San Jose, California-based Outset is competing in the market for dialysis equipment. Its Tablo hemodialysis system can be used in acute or chronic care facilities and was cleared for home use in 2020. The company also makes an accessory for the system, called TabloCart, which includes wheels, storage drawers, and water prefiltration to remove sediment and minerals from supply ...
Don Tracy, Associate Editor The catheters approved by the FDA include the Plato 17, a DMSO-compatible microcatheter, and the Socrates 38, an aspiration catheter specifically designed for treating ischemic strokes. Scientia Vascular announced that the FDA has approved two of its neurovascular catheters. According to the company, the Plato 17 microcatheter offers physicians the ability to control and stabilize neurovascular applications and is also DMSO compatible. The Socrates 38, which is currently in a limited market release, is an aspiration catheter for treating ischemic strokes. Scientia stated that the approvals mark a significant advancement in its medical technology portfolio.1 “Our FDA clearance is a significant milestone for Scientia Vascular. By applying proven microfabrication technology to catheters and designing our access and treatment devices for efficiency when used together, we’re providing physicians the next generation of neurovascular access tools.” said John Lippert, CEO, Scientia Vascular, in a press release. “I am ...
Don Tracy, Associate Editor Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients. Axurity Pharmaceuticals announced that the FDA has officially approved Myhibbin as a ready-to-use mycophenolate mofetil oral suspension for organ transplant patients. Myhibbin is the first FDA-approved liquid formulation of mycophenolate, which is used to avoid organ rejection in transplant recipients, according to Azurity. The company stated that this approval provides a significant new option for both pediatric patients above the age of three months and adults who have undergone kidney, heart, or liver transplants.1 “We are very pleased that adult and pediatric organ transplant recipients will soon have access to the only FDA-approved ready-to-use oral liquid formulation of mycophenolate,” said Richard Blackburn, CEO, Azurity Pharmaceuticals, in a press release. “Patients are our priority, and our purpose is to bring them new formulations that help them ...
Shanghai, China, May 6, 2024-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved by the United States Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally. Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6%. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease ...
Drugdu.com expert’s response: OTC stands for “Over-the-Counter,” referring to medications that can be purchased without a prescription from a healthcare professional. These medications are typically used to treat common health issues such as headaches, colds, fevers, and mild pains. In the United States, the Food and Drug Administration (FDA) regulates OTC drugs, and certain products require an application for OTC status before they can be sold on the market. Products that need to apply for OTC status according to the FDA include: 1.New Drugs: Drugs that have not been previously marketed require FDA approval before being sold as OTC products, regardless of their composition or effects. 2.Prescription Drugs: Some prescription drugs can apply for OTC status after undergoing clinical studies and safety assessments to demonstrate their safety and effectiveness. 3.Previously OTC Products with Safety Concerns: Certain OTC products may be required by the FDA to halt sales or undergo further ...
Abbott earned a groundbreaking FDA approval on Monday for its dissolving stent designed to unclog arteries below the knee. The device, called the Esprit BTK System, is meant to treat patients who have chronic limb-threatening ischemia below the knee. This condition is characterized by insufficient blood flow to the lower extremities, which leads to persistent pain, ulcers and tissue necrosis — with a significant risk of limb amputation if left untreated Chronic limb-threatening ischemia below the knee may be the most severe form of peripheral artery disease, said Jennifer Jones-McMeans, divisional vice president of global clinical affairs at Abbott’s vascular business. “This is really a landmark moment,” she said in an interview. “We’re looking at the first dissolving stent to treat below-the-knee arterial disease. And really, when you look at this severe form of upper artery disease, it’s considered kind of the terminal end of this disease — meaning that these patients have ...
Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg). The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018.The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1. All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower ...
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