Latest news with #U.S.FoodandDrugAdministration
The Hindu
a day ago
- Health
- The Hindu
Aurobindo recalling over 4,600 bottles of pain relieving tablets in U.S.
Generic drugmaker Aurobindo Pharma is recalling 4,608 bottles of pain relieving drug Acetaminophen Tablets, 325 mg, in the U.S. They are 100-count bottles and being recalled due to deviations from current Good Manufacturing Practices (cGMP), the U.S. Food and Drug Administration (U.S. FDA) said. Specially it is 'due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets),' the regulator said in its latest enforcement report. It is a voluntary recall and initiated by Aurobindo Pharma USA Inc., a subsidiary of the Hyderabad-based drugmaker, on May 22.
Associated Press
a day ago
- Health
- Associated Press
SeaStar's QUELIMMUNE Can Cut Pediatric Sepsis Deaths In Half
By Meg Flippin Benzinga DETROIT, MICHIGAN - June 27, 2025 ( NEWMEDIAWIRE ) - SeaStar Medical Holding Corp. (NASDAQ: ICU), the commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, has made a lot of inroads on that front with QUELIMMUNE. A humanitarian medical device, QUELIMMUNE treats pediatric patients with acute kidney injury or AKI due to sepsis or a septic condition. The QUELIMMUNE therapy received U.S. Food and Drug Administration approval in 2024 after clinical trials showed it could cut mortality in half from 50% to 25%. 'QUELIMMUNE is designed to target the innate immune response. When patients get very sick, it becomes very dysregulated and cells go haywire and trigger something called the cytokine storm,' said Dr. Kevin Chung, MD, Chief Medical Officer at SeaStar Medical. 'The QUELIMMUNE device is designed specifically to target the cytokine storm at the source of the storm and it is associated with really good outcomes, especially in the pediatric population where mortality was cut in half from 50% to 25%.' From The Golf Course To The ICU That was the case for Kurt, a young student and avid golfer who has won multiple golf awards even though he underwent two open-heart surgeries before his sixth birthday. Knowing at an early age that he couldn't compete in the sports other kids were playing, Kurt picked up golf and never looked back. But over the years, Kurt faced doctor visits and surgeries, culminating in a near-death experience. At the time, Kurt was being treated at Cincinnati Children's Hospital Medical Center, where Dr. Stuart L. Goldstein, MD, the lead researcher for QUELIMMUNE's two trials that led to the device's FDA approval, worked. Kurt went in for a planned surgery to address an artificial replacement from his pulmonary to aortic valve, but had to be opened up again two days later as a result of blood leaking from his heart at the site of surgery. Kurt was put on a ventilator and went into multiple-organ failure, caught hospital pneumonia, and ultimately endured a 12-day coma. He developed AKI and respiratory failure, and doctors prepared to put him on ECMO (Extracorporeal Membrane Oxygenation), a more invasive type of support. But Dr. Goldstein spoke with the on-staff cardiologist and Kurt's family and suggested that the QUELLIMUNE therapy would be helpful for him. 'Kurt just started to turn around within 24 to 48 hours and did not require ECMO. Kurt left the ICU within two to three weeks and resumed going back to school and golfing,' says Dr. Goldstein. 'It was quite dramatic and is emblematic of when we see this work, which is far more often than not, patients turn around really really quickly when you wouldn't expect them to.' A Christmas Miracle For Kurt's father, David, the QUELIMMUNE therapy was a last-ditch effort to save his son, who had been languishing in the ICU for eleven days. Every night, the doctors would offer up different therapies and treatment ideas to stop his son's organs from failing and as luck would have it, one evening David and his nephew, who is also a doctor, ran into Dr. Goldstein outside of his son's room. Dr. Goldstein said he thought the QUELIMMUNE therapy could help with the inflammation and the family decided, given the apparently bleak prognosis, to give it a try, recalls David. From day two on, the inflammatory markers improved and continued to get a lot better. 'The inflammatory markers improved every day,' says David. His son was woken from the coma on day six of treatment, December 24. 'It was a Christmas miracle. He was awake and his numbers were improving,' his father said. Kurt had a tough recovery ahead of him when he woke up. He entered the hospital weighing 150 pounds and left at about 120 pounds. But by the beginning of March, he had regained his strength and energy and was golfing again. That is one of the other aspects of the QUELIMMUNE therapy that astonishes Dr. Goldstein, and makes him so optimistic that the device can treat other children with AKI. Typically 10% to 30% of pediatric patients who survive an AKI episode require chronic dialysis, but Kurt didn't. 'It is nothing I've seen before in clinical medicine in the last quarter century,' said Dr. Goldstein. Featured image fromShutterstock This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originallypublished on further disclosureshere.
Business Wire
a day ago
- Business
- Business Wire
Omeros Submits Narsoplimab Marketing Authorization Application to the European Medicines Agency for the Treatment of TA-TMA
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The MAA includes response-based analyses in narsoplimab-treated TA-TMA patients as well as analyses comparing overall survival between narsoplimab-treated patients and a well-matched external control group. Collectively, the results demonstrate a 61% response rate and, compared to the matched external control, a three-fold improvement in overall survival. The submission also includes outcomes in over 130 TA-TMA patients treated with narsoplimab under Omeros' expanded access program. Narsoplimab has been granted orphan drug designation by the EMA for treatment in hematopoietic stem cell transplant, enabling review of the MAA through the centralized procedure. This allows for a single marketing authorization to cover all EU member states and the European Economic Area countries of Iceland, Liechtenstein and Norway. The review procedure begins in mid-July and will follow a standard review timeline. The Committee for Medicinal Products for Human Use (CHMP) will conduct the scientific assessment and will issue an opinion at the end of the review. This opinion is typically adopted by the European Commission, with a final decision expected in mid-2026. The MAA submission follows the acceptance for review by the U.S. Food and Drug Administration (FDA) of the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of TA-TMA. The resubmission was assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025. About Narsoplimab Narsoplimab, also known as 'OMS721,' is an investigational fully human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 has been demonstrated to leave intact the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. A biologics license application (BLA) for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is under review by the U.S. Food and Drug Administration (FDA) and Omeros has submitted the corresponding European MAA. FDA has granted narsoplimab breakthrough therapy and orphan drug designations for TA-TMA and orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant. About Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of TA-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of TA-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of TA-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common. There is no approved therapy or standard of care for TA-TMA. About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the 'safe harbor' created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'goal,' 'intend,' 'likely,' 'look forward to,' 'may,' 'objective,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'slate,' 'target,' 'will,' 'would' and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated review process and timing of FDA action on the resubmitted BLA for narsoplimab in the United States, the anticipated review process and timing of EMA action on the MAA submission, the prospects for obtaining FDA or EMA approval of narsoplimab in any indication, and expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the potential commercialization of narsoplimab if it is approved by FDA or the EMA, are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable or unexpected regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in the narsoplimab BLA or narsoplimab MAA, inability to respond satisfactorily to information requests during regulatory review of the narsoplimab BLA or MAA, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, and whether FDA and the EMA determine the registry used in our statistical analysis is sufficiently representative of TA-TMA patients, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations on favorable terms or at all, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading 'Risk Factors' in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2025 and in subsequent reports filed with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Time Business News
a day ago
- Business
- Time Business News
Pioneering Technologies in Regenerative Medicine
Regenerative medicine is a branch of medical science that aims to repair, replace, and regenerate damaged tissues or organs to bring them back to normal function. Stem cell research and regenerative technologies are creating new opportunities for treatment and accelerating growth in the regenerative medicine market. The growing prevalence of chronic disease, increasing funding, and technology advances in gene therapy, an increasing aging population, and more favorable regulations are major contributors to the growing share and speed of development of the regenerative medicine. Key Growth Drivers and Opportunities Rising Number of Aging Population: With the global aging phenomenon, there will be increased incidences of chronic and degenerative diseases such as osteoarthritis, cardiovascular ailments, neurodegenerations, and musculo-skeletal problems, very much in demand for advanced treatment options. Regenerative medicine comprising stem cell therapy, gene therapy, and tissue engineering, among others, presents viable and sustainable alternatives in contrast to conventional treatments such as medication and surgery, which provide temporary relief. Given that regenerative medicine addresses the actual cause of tissue and organ damage, it significantly enhances the quality of life and decreases long-term care burdens, serving as the prime growth driver for the regenerative medicine. Challenges The regenerative medicine is limited by high treatment costs, difficult regulatory approvals, not enough long-term clinical data, and problems in big manufacturing and making everything the same which can block easy acceptance and availability. Innovation and Expansion Beam Therapeutics' BEAM-302 has granted RMAT status by the FDA for Alpha-1 Antitrypsin Deficiency In May 2025, The U.S. Food and Drug Administration (FDA) has designated BEAM-302, a liver-targeting lipid-nanoparticle (LNP) formulation of a guide RNA and an mRNA encoding a base editor, as Regenerative Medicine Advanced Therapy (RMAT). This designation is intended to correct the disease-causing mutation in patients with alpha-1 antitrypsin deficiency (AATD). Beam Therapeutics Inc. is a biotechnology company that develops precision genetic medicines through base editing. There is a substantial unmet need for efficient treatments that may address the whole range of symptoms for AATD, an inherited genetic illness that affects the lungs and/or liver and causes early onset emphysema and liver disease. The FDA Gives BrainChild Bio's CAR T Therapy for Pediatric Brain Tumors RMAT Status In May 2025, The U.S. Food and Drug Administration (FDA) has designated the investigational B7-H3 targeting autologous CAR T-cell therapy as a Regenerative Medicine Advanced Therapy (RMAT) for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor. This news was released by BrainChild Bio, Inc., a clinical-stage biotechnology company that is developing CAR T-cell therapies to treat tumors in the central nervous system (CNS). The FDA Designates MeiraGTx's AAV-GAD Gene Therapy as an RMAT for Parkinson's disease In May 2025, AAV-GAD has been designated by the U.S. Food and Drug Administration (FDA) as Regenerative Medicine Advanced Therapy (RMAT) for the treatment of Parkinson's disease that is not sufficiently controlled with anti-Parkinsonian drugs. This announcement was made today by MeiraGTx Holdings plc, a vertically integrated, clinical-stage genetic medicines company. This RMAT was granted after the FDA received favorable results from three clinical trials showing the advantages of AAV-GAD when given as a single stereotactic infusion to the brain's subthalamic nucleus. Inventive Sparks, Expanding Markets Key players in the regenerative medicine market are R&D Systems, Inc., Moderna, Novartis AG and others. These key players are focusing on increasing the research and development of advanced therapies and innovative strategies for 3D bioprinting advancement, and more acquisitions to enhance product offerings through collaborations will be projected to drive the target market. About Author: Prophecy is a specialized market research, analytics, marketing and business strategy, and solutions company that offer strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high value opportunities in the target business area. Also, we help our client to address business challenges and provide best possible solutions to overcome them and transform their business. TIME BUSINESS NEWS
Newsweek
2 days ago
- Health
- Newsweek
Cookie Recall Update For 15 States as FDA Issues Risk Level
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A food recall of nearly 6,000 cases of cookies distributed across 15 states has been given the U.S. Food and Drug Administration's (FDA) second-highest risk level. Carley's Inc. voluntarily recalled 5,826 cases of its Soft Baked Iced Lemon Cookies, which contained a misbranded yellow color additive, which was incorrectly labeled "Artificial Yellow Color" instead of the regulatory "FD&C Yellow #5" (or Tartrazine), the FDA said. The agency on Wednesday classified the recall a Class II, reserved for situations in which a product may cause temporary or medically reversible adverse health issues or there is a remote probability of serious adverse health consequences. The cookies were shipped to wholesalers in the following states: Illinois, Michigan, Iowa, Louisiana, Maryland, Pennsylvania, Virginia, Minnesota, Alabama, Texas, Georgia, South Carolina, New York, North Carolina, and West Virginia. Newsweek contacted Carley's via its information email on Thursday. What To Know The recalled product, Carley's Soft Baked Iced Lemon Cookies (5.34oz plastic tray), bears UPC code 7 40235 50011 0 and various lot codes including 01726-040225, 11245-012825, 031026-051425, 061925-082324, 080525-100924, 081725-102124, 091025-111424, and 112425-012825. Carley's shipped 5,826 cases (nearly 70,000 units) to wholesalers who then distributed them to retail stores in 15 states. The recall was initiated on June 6. Carley's Inc. notified its customers and wholesalers using a combination of email, fax, letter, press release, telephone, and personal visits. No initial press release was formally issued for this recall. Stock photo shows homemade cookies. Stock photo shows homemade cookies. Getty Images The FDA requires specific identification of food color additives due to potential sensitivities. FD&C Yellow #5 (also known as tartrazine) has been associated with rare allergic-type reactions, particularly among individuals with aspirin sensitivity. FD&C Yellow No. 5 is approved by the U.S. Food and Drug Administration (FDA) for use in foods, drugs, and cosmetics. It must be listed on ingredient labels because some people may have allergic reactions or sensitivities. No U.S. state outright bans FD&C Yellow No. 5, but there have been increasing regulatory and labeling efforts around artificial food dyes, particularly in states like California and New York. The FDA's Recall Levels Explained Recalls are classified into a numerical designation (I, II, or III) by the FDA to indicate the relative degree of health hazard presented. The categories are: Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What Happens Next The voluntary recall remains ongoing. The recall will remain active until the FDA and Carley's Inc. have resolved the labeling issue and ensured that all misbranded products are removed from the market. Consumers who have purchased affected cookies should return them for a full refund, and can monitor the FDA recall database for updates.
