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GlobalData

Pharma

Intercept opportunity to market first-ever NASH therapy diminishes with negative FDA GDAC vote, says GlobalData

The FDA’s Gastrointestinal Drugs Advisory Committee (GDAC) has recently voted against Intercept Pharmaceutical’s new drug application (NDA) for obeticholic acid (OCA) 25 mg oral tablets as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH) on the basis that the benefits did not outweigh the risks. The move will significantly reduce the potential […]
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Obicetrapib holds potential to become first CETP inhibitor to advance to clinical practice, says GlobalData

NewAmsterdam Pharma presented positive data from its Phase II ROSE2 trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy at the National Lipid Association (NLA) Scientific Sessions 2023. The study demonstrated the efficacy of obicetrapib in combination with ezetimibe resulting in the reduction of low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein […]
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FDA approval of subcutaneous Vyvgart tackles one of the unmet needs in myasthenia gravis indication, says GlobalData

Following the news that the FDA has approved Argenx’s subcutaneous formulation of efgartimod alfa, branded as Vyvgart Hytrulo, for use in myasthenia gravis (MG); Barbora Salcman, Neurology Analyst at GlobalData, offers her view: “The approval comes after a period of uncertainty and extends the availability of Vyvgart to acetylcholine receptor autoantibody positive (AChR+) patients diagnosed […]
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EU nod boosts Bimzelx’s profile as innovative interleukin-17 inhibitor therapy, says GlobalData

UCB recently announced the European Commission approval for Bimzelx (bimekizumab), its humanized monoclonal IgG1 antibody, which exerts simultaneous selective inhibition of interleukin 17A (IL-17A) and IL-17F, for adults with active psoriatic arthritis (PsA), and active non-radiographic axial spondyloarthritis (axSpA) who exhibit intolerance to non-steroidal anti-inflammatory drugs. Representing a distinctive mechanism of action as a dual […]
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Healthcare professionals see biosimilars as solution to tackle rising costs, finds GlobalData survey

The healthcare industry continues to face the challenges such as persistent inflation in a post-COVID-19 world. Healthcare professionals (HCPs) believe that biosimilars could provide costs savings for the patients and healthcare systems and their use should be encouraged, according to a survey by  GlobalData, a leading data and analytics company. GlobalData survey, “The Impact of […]
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Study indicating bacterial infection could cause endometriosis suggests antibiotics as potential treatment, says GlobalData

In a study published in Science Translational Medicine, researchers from Nagoya University documented how Fusobacterium may play a key role in spurring the development of endometriosis after the bacterium was detected in over 60% of women with the condition. The findings of the study are encouraging and could point to a potential role for antibiotics as treatment […]
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VALUE-Dx initiative highlights potential for improved respiratory infection diagnostics to decelerate AMR, says GlobalData

VALUE-Dx, a first-of-its-kind Innovative Medicines Initiative (IMI) project which aims to improve the use of antibiotics in community care settings, has recently released preliminary information from its upcoming consensus statement on rapid diagnostic tests (RDT) for acute respiratory tract infections (ARTIs) at a post- European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) conference. The […]
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Label extension will help Injectafer continue penetrating IV iron therapy market, says GlobalData

Injectafer recently secured approval in the US for improvement in exercise capacity in adults with symptomatic heart failure (HF).  A significant number of chronic HF patients suffer from iron deficiency, and these patients are either not diagnosed or do not receive adequate treatment for iron deficiency. Injectafer’s approval allows potentially iron-deficient patients to better manage […]
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Cannabinoids hold potential to be future of pain medication and address opioid epidemic, says GlobalData

On May 9, National Fentanyl Awareness Day was observed in recognition of the US opioid crisis. Accordingly, the development of non-opioid painkillers is experiencing a surge in activity, and despite numerous novel targets receiving high levels of attention, cannabinoids have emerged as strong favorites to replace opioid-related medications. As a result, they hold the potential […]
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Merck lawsuit against US government raises constitutional concerns over drug pricing regulation, says GlobalData

Pharmaceutical giant Merck has filed a lawsuit in the US District Courts against the federal government, claiming it violates constitutional rights and undermines drug pricing negotiation powers. The lawsuit could have significant implications for the future of drug pricing regulation and may prompt other pharmaceutical companies to challenge the Inflation Reduction Act as well, says […]
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International NASH Day response reveals growing interest in raising disease awareness, says GlobalData

The increased response to International NASH Day (8 June) in 2023 demonstrates growing interest from both industry and public bodies in raising the awareness of non-alcoholic steatohepatitis (NASH). This reflects the rising prevalence of the disease, as well as recent clinical trial developments, says GlobalData, a leading data and analytics company. Jay Patel, Pharma Analyst […]
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