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 ...
The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. By Frank Vinluan A primary immunodeficiency whose rarity means it can go undiagnosed or misdiagnosed in a patient for years now has its first drug. The FDA has approved a once-daily therapy that addresses the underlying genetic problem driving the inherited disorder, known as WHIM syndrome. The regulatory decision announced Monday for the X4 Pharmaceuticals drug covers WHIM patients age 12 and older. The daily capsule, known in development as mavorixafor, will be commercialized under the brand name Xolremdi (pronounced “zohl-REM-dee”). The name WHIM is an acronym for warts, hypogammaglobulinemia, infections, and myelokathexis, which are the four common clinical presentations of the disease. But the disease is not limited to those symptoms and it presents differently from one patient to another. There is no standard ...
The US Food and Drug Administration (FDA) has approved X4 Pharmaceuticals‘ XOLREMDI (mavorixafor) capsules for patients aged 12 and above with warts, hypogammaglobulinemia, infections and myelokathexis (WHIM) syndrome. This marks a significant advancement in the treatment of WHIM syndrome, a rare combined primary immunodeficiency and chronic neutropenic disorder. XOLREMDI is a selective CXC chemokine receptor 4 (CXCR4) antagonist. It is the first drug specifically indicated to treat patients with WHIM syndrome. X4 Pharmaceuticals president and CEO Paula Ragan stated: “The approval of XOLREMDI is a transformational milestone both for X4 and, more importantly, for the WHIM syndrome community. “We are incredibly grateful to the people living with WHIM syndrome, their families, and the investigators who took part in our clinical programme, to US regulators for their continued focus on rare-disease treatment development, and to our dedicated employees for making this targeted breakthrough therapy a reality.” ...
Zydus Lifesciences announced that the New Drug Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA). CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS) obtained an exclusive license for the Product from Zydus in 2020. Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis. When kidneys are impaired as in patients suffering from Chronic Kidney Disease, EPO production is impaired, leading to development of anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, reducing hepcidin thereby improves iron availability. Discovered and developed by Zydus, Desidustat is being marketed by the group ...
Dive Brief Medtronic has received Food and Drug Administration approval for its Inceptiv closed-loop spinal cord stimulator (SCS) for the treatment of chronic pain, the company said Friday. The closed-loop system is meant to reduce overstimulation compared to the open-loop technology used by Medtronic’s rivals, such as Abbott, Boston Scientific and Nevro. Evercore ISI analysts think Medtronic has lost share to Abbott over the past two years, and the launch of Inceptiv could help the company regain ground in the coming quarters. Dive Insight Users of open-loop SCS receive a predetermined amount of stimulation, which is set when the physician programs the device, regardless of what the patient is doing. The fixed output can result in moments of overstimulation that are uncomfortable, potentially leading users to choose a lower, less effective level of stimulation. Open-loop efficacy may fall over time, too. Closed-loop systems, such as Medtronic’s Inceptiv device, adjust their ...
CHENGDU, China, April 29, 2024 /PRNewswire/ — Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing patients in its Phase 2a clinical trial (NCT06363461) of topical TDM-180935 ointment. This clinical trial in the Atopic Dermatitis (AD) program includes 8 weeks dosing of two different active formulation strengths and placebo in a study entitled, “A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients”. It is a randomized, vehicle-controlled, parallel group comparison study with an open-label PK sub-study. Objectives are to evaluate the safety and efficacy of topical TDM-180935 as well aspharmacokinetics. Seven U.S. clinical sites are currently participating in this study under an open IND with FDA. Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “We expect the current study to support ...
Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver cancer, and deaths related to viral hepatitis, affecting hundreds of millions. Early detection plays a crucial role in initiating timely treatments that improve long-term health outcomes. The detection of the hepatitis B virus surface antigen (HBsAg) in serum or plasma is an early indicator of infection. HBsAg is the first serological marker to appear in the progression of the disease, emerging in the blood two to three weeks before symptoms become apparent. Traditional testing protocols typically require retesting and subsequent confirmatory tests for reactive samples. Now, two newly introduced hepatitis assays use advanced technology to elevate efficiency and confidence in hepatitis testing. Beckman Coulter Diagnostics (Brea, CA, USA) has extended the menu of DxI 9000 Immunoassay Analyzer assays with ...
Recently, Chiatai Tianqing Pharmaceutical Group’s self-developed Class 1 innovative drug TQA3038 (siRNA) successfully completed Phase I clinical study. The company will start the follow-up clinical study of TQA3038 injection in patients with chronic hepatitis B in the near future. TQA3038 injection is a small interfering RNA (siRNA) drug independently developed by Chiatai Tianqing to target hepatitis B virus (HBV), with the indication of chronic hepatitis B. TQA3038, as an N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, can be enriched in the liver, degrade the targeted RNA, inhibit translation of the relevant proteins, thus blocking the replication of hepatitis B virus. TQA3038 adopts a nucleic acid sequence with independent intellectual property rights and has strong in vitro and in vivo antiviral activity. The “randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic profile of TQA3038 in healthy adult subjects” initiated by the Company has been successfully completed recently. The ...
Researchers from the universities of Oxford, Nottingham and King’s College London (KCL) have shown that a new heart disease calculator can accurately predict an individual’s ten-year risk of cardiovascular diseases and identify high-risk patients. Published in Nature Medicine, the QR4 tool could save over 2,500 chronic obstructive pulmonary disease (COPD) patients a year, promoting earlier recognition of the disease and its associated cardiovascular risk. Currently the leading cause of death globally, CVDs are responsible for an estimated 17.9 million deaths each year, according to the World Health Organization. They are disorders of the heart and blood vessels. Researchers from KCL, along with the QRISK team based at the universities of Oxford and Nottingham, conducted a large-scale epidemiological study involving over 13 million UK citizens, which revealed an increased risk of severe cardiovascular events in female patients with COPD. The team identified seven new unique risk factors common to all genders ...
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