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GlobalData

Pharma

FDA approval for Madrigal’s Rezdiffra in metabolic dysfunction-associated steatohepatitis will set precedence for approval of future pipeline agents, says GlobalData

Following the news on 14 March 2024 that FDA has granted accelerated approval for Madrigal Pharmaceuticals’ thyroid hormone receptor (THR)-β agonist Rezdiffra (resmetirom) for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis; Sravani Meka MPH, Senior Pharma Analyst at GlobalData, a leading […]
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Pharmaceutical companies pursuit of patient empowerment calls for enhanced effort, says GlobalData

Pharmaceutical companies are increasingly recognizing the importance of empowering patients to take charge of their health. However, there is still room for improvement in supporting patients. This underscores the need for greater efforts to meet patient needs and enhance engagement, says GlobalData, a leading data and analytics company. GlobalData’s latest survey-based* Thematic Intelligence report, “Patient […]
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Cell therapies show promise for addressing Parkinson’s disease non-motor symptoms, says GlobalData

Within the current treatments of Parkinson’s disease (PD) there is an unmet need for addressing the loss of dopaminergic neurons and non-motor symptoms. At the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases, BlueRock Therapeutics (a subsidiary of Bayer) presented positive results from their Phase I clinical trial of the gene-modified cell therapy Bemdaneprocel […]
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Biomarkers becoming important for approval of amyotrophic lateral sclerosis therapies, says GlobalData

The recently concluded AD/PD 2024 International Conference on Alzheimer’s Disease (AD) and Parkinson’s Disease (PD) focused on innovative approaches poised to revolutionize the treatment of amyotrophic lateral sclerosis (ALS) and the use of neurochemical biomarkers in ALS drug development. As biomarkers are used for early diagnostics in clinics and as outcome parameters for novel treatment […]
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Biotech funding set for recovery in 2024, reveals GlobalData

The biopharmaceutical industry is witnessing a shift in investor sentiment. Despite facing challenges such as declining venture financing and macroeconomic pressures, there exists optimism about a recovery in biotech funding. Healthcare professionals globally express cautious optimism, emphasizing the importance of alternative funding avenues and industry partnerships. This dynamic landscape sets the stage for potential growth […]
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Diagnosed incident cases of non-small cell lung cancer across 8MM to reach 1.46 million in 2032, forecasts GlobalData

The diagnosed incident cases of non-small cell lung cancer (NSCLC) in the eight major markets (8MM*) are projected to increase at an annual growth rate (AGR) of 3.33% from 1.01 million in 2022 to 1.46 million in 2032, forecasts GlobalData, a leading data and analytics company. GlobalData’s latest report, “Non-Small Cell Lung Cancer (NSCLC): Epidemiology […]
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Opdivo to face direct competition with Keytruda and Padcev combination in bladder cancer space, says GlobalData

Bristol Myers Squibb’s Opdivo was recently granted FDA approval in combination with cisplatin and gemcitabine as a first-line treatment for metastatic urothelial carcinoma (mUC). With this approval, Opdivo positions itself to compete with Merck & Co’s immune checkpoint inhibitor (ICI) Keytruda in combination with Astellas and Pfizer’s Padcev, a nectin-4-directed antibody-drug conjugate (ADC). The Keytruda/Padcev […]
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TauRx’s HMTM could become first oral DMT targeting Tau for Alzheimer’s disease, says GlobalData

Following the Phase III LUCIDITY trial (NCT03446001) results announced by TauRx at the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases, for hydromethylthionine mesylate (HMTM); Philippa Salter, Senior Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “At AD/PD 2024, TauRx announced that it has initiated regulatory discussions with both […]
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Oncology dominates CRISPR landscape, reveals GlobalData

The Medicines and Healthcare products Regulatory Agency (MHRA) approved Vertex’s exagamglogene autotemcel (Casgevy) in late 2023. Subsequently, it became the inaugural CRISPR-based drug for the hematological indications beta thalassemia and sickle cell disease (SCD). Despite this approval, the CRISPR landscape is dominated by oncology, which accounts for 30% of all active CRISPR drugs. The precision […]
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Patient and healthcare professional relationship crucial for effective care, says GlobalData

In healthcare, the foundation of effective care lies in the trust between patients and healthcare professionals (HCPs). Central to this trust is the quality of information conveyed by HCPs, which directly impacts patient satisfaction and empowerment. A robust patient-physician relationship hinges on patients’ confidence in the knowledge and expertise of their healthcare providers, underscoring the […]
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Beacon Therapeutics AGTC-501 poses formidable challenge to Spark Therapeutics Luxturna in retinitis market, says GlobalData

Beacon Therapeutics’ gene therapy AGTC-501 (laruparetigene zovaparvovec) is in the spotlight with encouraging interim results from SKYLINE trial in the retinitis pigmentosa (retinitis) market. Offering a new mechanism of action, it presents a formidable challenge to Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), the current frontrunner in gene therapy for retinitis. With promising safety profiles and ongoing […]
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Opportunities for cell and gene therapy landscape remain high but so does challenges, says GlobalData

Cell and gene therapies (CGTs) have been gaining traction within the medical community as treatment options that are expected to replace lifelong management of chronic diseases with fewer number of doses, which could offer significant benefits for both patients and strained healthcare systems. However, alongside these opportunities, regulatory barriers and cost concerns pose challenges to […]
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High ADHD comorbidity rates offer opportunity for pipeline products to capture market, says GlobalData

Attention-deficit/hyperactivity disorder (ADHD) is a clinically heterogenous neurodevelopmental disorder with high rates of comorbidity with other childhood-onset psychiatric disorders as well as learning disorders. As a result, pipeline products capable of targeting both ADHD and comorbid symptoms will have a competitive edge to capture a highly saturated ADHD market, says GlobalData, a leading data and […]
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Biogen needs Leqembi to be successful following discontinuation of Aduhelm, says GlobalData

Biogen’s stance at the upcoming AD/PD 2024 International Conference on Alzheimer’s disease (AD) and Parkinson’s disease (PD) that will be held on March 5-9 will demonstrate its future plans for AD following the discontinuation of Aduhelm (aducanumab), its anti-amyloid beta (Aβ) monoclonal antibody (mAb). Against this backdrop, the success of Leqembi (lecanemab) remains important for […]
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Novel approaches for amyotrophic lateral sclerosis will transform treatment landscape, says GlobalData

Innovative approaches are poised to revolutionize the treatment of amyotrophic lateral sclerosis (ALS), a challenging and rare disease. The current therapies have limitations in efficacy, prompting a surge in exploration of novel disease-modifying drugs (DMD). With 109 pipeline candidates in various stages of development, the ALS treatment landscape is primed for transformation, offering hope for […]
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