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FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
- Source: drugdu
- 110
- July 9, 2023
Antidepressant prescriptions continue to steadily grow in England

The number of antidepressant drugs being prescribed on the UK’s National Health Service (NHS) rose again, according to a quarterly report by the NHS Business Services Authority (NHSBSA). The report, which covers the months from October 2022 to December 2022, lists the number of mental health medicines prescribed in England according to the five British National Formulary (BNF) drug groups. This includes drugs that could have been dispensed in England, Scotland, Wales, Isle of Man of the Channel Islands. The British National Formulary classifies mental health medications into different groups based on their use. They are antidepressants, hypnotics and anxiolytics, central nervous system (CNS) stimulants and attention-deficit/hyperactivity disorder (ADHD) drugs, dementia medication, and antipsychotics. In the Q3 2022-2023, period antidepressant drugs were the most prescribed drug class, totalling nearly 22 million items, a 2.67% increase compared to the same period in the previous year. The rise is part of an ...
- Source: drugdu
- 112
- July 9, 2023
GSK’s ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients

GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach tough-to-treat patients who have difficulty controlling the virus with existing daily oral therapies, GSK’s ViiV Healthcare is getting creative. To seek an approval for Cabenuva in patients who aren’t virologically suppressed while on oral drugs, GSK’s ViiV is exploring running a clinical trial using a historical control group. This would replace the standard practice of randomizing some patients in the study to receive standard-of-care oral meds, ViiV’s R&D head Kimberly Smith, M.D., said during a recent interview. The FDA in February unveiled draft guidance laying out the considerations for the use of external control groups in clinical trials to prove a drug’s safety and efficacy. The gist is, ...
- Source: drugdu
- 105
- July 9, 2023
Horizon shares positive results for Uplizna in neuromyelitis optica spectrum disorder

Horizon Therapeutics has shared positive new MRI data from a late-stage study of Uplizna (inebilizumab-cdon) in patients with neuromyelitis optica spectrum disorder (NMOSD). Approximately one to ten per 100,000 people are affected by NMOSD, a rare and debilitating autoimmune disease characterised by inflammatory lesions that primarily damage the optic nerve and spinal cord. Most patients experience unpredictable relapses that reoccur after days, months or even years and may lead to further disability. Uplizna is the first and only CD19+ B-cell-depleting therapy approved by the US Food and Drug Administration and European Commission to treat NMOSD in adults who are AQP4-IgG positive. Around 80% of all patients with NMOSD test positive for anti-AQP4 antibodies. A new analysis of MRI data from the phase 3 N-MOmentum trial, presented by Horizon at this year’s Congress of the European Academy of Neurology in Budapest, shows that Uplizna effectively reduced the formation of subclinical (asymptomatic) ...
- Source: drugdu
- 121
- July 9, 2023
Immunotherapy significantly improves overall survival for advanced NSCLC patients

A global study, led by UCL and UCLH and sponsored by Roche, has shown that the cancer immunotherapy atezolizumab significantly improved the overall survival of advanced stage non-small cell lung cancer patients who were not able to be treated with platinum-containing chemotherapy, when compared to single-agent chemotherapy. The trial results, published today in The Lancet, are good news for non-small cell lung cancer patients who are not eligible for standard of care platinum-based chemotherapy, due to concerns about their ability to withstand the treatment. Lung cancer is the leading cause of cancer death worldwide, with around 2.2 million new cases and 1.8 million deaths a year. The majority of patients present with advanced stage non-small cell lung cancer (NSCLC) . For the fittest patients with advanced stage NSCLC, first-line immunotherapy with or without platinum-based doublet chemotherapy (PDC) is now established as the standard of care treatment. This follows several randomized ...
- Source: drugdu
- 127
- July 9, 2023
New AI system could revolutionize the diagnosis of valvular heart disease

AI (artificial intelligence) may sound like a cold robotic system, but Osaka Metropolitan University scientists have shown that it can deliver heartwarming-;or, more to the point, “heart-warning”-;support. They unveiled an innovative use of AI that classifies cardiac functions and pinpoints valvular heart disease with unprecedented accuracy, demonstrating continued progress in merging the fields of medicine and technology to advance patient care. The results will be published in The Lancet Digital Health. Valvular heart disease, one cause of heart failure, is often diagnosed using echocardiography. This technique, however, requires specialized skills, so there is a corresponding shortage of qualified technicians. Meanwhile, chest radiography is one of the most common tests to identify diseases, primarily of the lungs. Even though the heart is also visible in chest radiographs, little was known heretofore about the ability of chest radiographs to detect cardiac function or disease. Chest radiographs, or chest X-Rays, are performed in ...
- Source: drugdu
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- July 9, 2023
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)

SUZHOU, China, July 7, 2023 /PRNewswire/ — Transcenta Holding Limited (“Transcenta”) (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. In addition, we are in the process of EU and FDA regulatory interaction. Gastric cancer (GC) is the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality. The five year survival rate for gastric cancer is still around 30%. Nivolumab, an anti-PD-1 antibody, has been approved globally for the first line treatment ...
- Source: drugdu
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- July 9, 2023
Safety Concerns About New Weight Loss Drugs Brew as Demand Soars

By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
- Source: drugdu
- 112
- July 9, 2023
FTC intervenes to correct Medtronic’s ‘erroneous assertions’ in antitrust case

Dive Brief The Federal Trade Commission has intervened in a legal case to correct what it called “erroneous assertions and mistaken legal points” made by Medtronic. In an amicus brief filed Monday, the FTC rebuts aspects of Medtronic’s defense against accusations made by Applied Medical Resources in an antitrust case. The FTC has taken no position on the accuracy of the allegations but filed the brief because it said Medtronic made “wrong” arguments with “broad implications for antitrust enforcement” in its filing to dismiss Applied’s claims. Dive Insight Applied Medical filed a lawsuit against Medtronic earlier this year. The manufacturer of bipolar energy devices accused Medtronic of conspiring to bundle devices for cutting tissue and sealing vessels “in a way that is unhealthy for competition, hospitals, and patients in need of medical treatment.” Medtronic called the claims “baseless” and moved to dismiss the case. The argument for dismissing the case ...
- Source: drugdu
- 118
- July 8, 2023
Kidney transplant recipients may benefit from new fluid therapy

A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25 per cent. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood – instead of the usual practice of using normal saline (sodium chloride and water). David Johnson, UQ Professor, said, “Of those study participants who received intravenous Plasma-Lyte 148, 30 per cent needed dialysis after their transplants, compared to 40 per cent for those given normal saline. This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal ...
- Source: drugdu
- 141
- July 8, 2023

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