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GlobalData
GlobalData

Pharma

NICE rejects second Alzheimer’s drug but opportunity remains for decision change, says GlobalData

Following the news that the National Institute for Health and Care Excellence (NICE) is not recommending Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Kisunla (donanemab) on the NHS following its approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease […]
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Johnson & Johnson’s subcutaneous Tremfya holds potential to set new standard in Crohn’s disease treatment, says GlobalData

Johnson & Johnson‘s subcutaneous (SC) Tremfya (guselkumab) demonstrated strong results in the Phase III GRAVITI trial, marking a major breakthrough in the treatment of Crohn’s disease (CD). This patient-friendly regimen could enhance patient autonomy, improve adherence, and lead to better outcomes. The GRAVITI results position guselkumab as a significant new option in CD, says GlobalData, […]
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UNI-494 trial results highlight Unicycive’s potential to differentiate in AKI space, says GlobalData

Unicycive Therapeutics recently announced positive results from its Phase I trial of UNI-494, showing that the drug’s use was observed to be safe and well-tolerated in both single ascending and multiple ascending doses. The trial results also showed that UNI-494 absorption was fast, rapidly metabolized, and plasma concentration increases when dose increases. The drug potentially […]
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S1P receptor modulators face uncertain future in Crohn’s disease amid efficacy and trial setbacks, says GlobalData

Pfizer’s upcoming presentation at United European Gastroenterology Week (UEGW) 2024 will reveal the initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD), showing modest efficacy in endoscopic response and remission rates. With its in-class competitor ozanimod also underperforming in trials, the outlook for S1P receptor modulators […]
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Global leaders unite to combat AMR: targets set at UNGA are urgently needed, says GlobalData

In a crucial step forward, world leaders at the United Nations General Assembly (UNGA) have pledged to reduce antimicrobial resistance (AMR) associated fatalities by 10% by 2030. This declaration, which emphasizes a multi-sector approach, reflects a necessary shift toward a comprehensive “One Health” approach, integrating human, animal, and environmental health. By prioritizing collaboration and innovative […]
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A schizophrenia win for BMS’s Cobenfy, but challenges lie ahead, says GlobalData

Bristol Myers Squibb (BMS) has recently secured approval from the US FDA for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia. Cobenfy has a mechanism of action (MOA) distinct from traditional antipsychotics. However, as the drugs most widely used to treat schizophrenia are inexpensive, genericized atypical antipsychotics, the schizophrenia market is […]
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Ebglyss FDA approval intensifies competition in atopic dermatitis market, says GlobalData

Eli Lilly‘s Ebglyss (lebrikizumab) has recently received approval in the US, adding a new competitor to the atopic dermatitis (AD) market alongside therapies like tralokinumab and dupilumab. Although there are current treatment options ranging from topical therapies to systemic treatments  there is a significant unmet need remains for safer and more effective long-term AD therapies, […]
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Non-opioid medications for addiction treatment remain key unmet need in OUD market in 8MM, reveals GlobalData

Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. In August 2024, 110 high-prescribing psychiatrists, addiction specialists, neurologists, and primary care physicians from eight major markets (8MM*) were surveyed by GlobalData on the key unmet […]
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ARS Pharmaceuticals’ Neffy poised to disrupt epinephrine market as first needle-free nasal spray, says GlobalData

ARS Pharmaceuticals’ Neffy, the first needle-free epinephrine nasal spray, is poised to significantly impact the treatment of life-threatening allergic reactions like anaphylaxis following FDA approval in August 2024. With ease of use paired with a strong patient-assistance program, Neffy is set to disrupt the epinephrine market, according to GlobalData, a leading data and analytics company. […]
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Sanofi/Regeneron’s Dupixent set to dominate COPD biologics market share following FDA approval, says GlobalData

Following the Food and Drug Administration (FDA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on 27 September 2024: Asiyah Nawab, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view: “Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the FDA as the first biologic for uncontrolled […]
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China’s surge in antibody-drug conjugates positions it as key oncology market, says GlobalData

Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China’s burgeoning oncology sector. With a little over 100 ADC candidates in various stages of development, Chinese companies lead the Asia-Pacific (APAC) region. As cancer remains a significant health challenge, strategic collaborations with major pharmaceutical companies are essential for advancing research and enhancing […]
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GlobalData poll reveals microbiome’s essential role in health

Healthcare professionals widely recognize the microbiome’s vital contributions to digestion, immune function, and overall well-being. The majority of surveyed respondents view a balanced microbiome as essential to sustain health and prevent various diseases, underscoring its crucial role of in maintaining human health, according to a recent poll conducted by GlobalData, a leading data and analytics […]
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AstraZeneca’s FluMist approval for self-administration could increase flu vaccine uptake, says GlobalData

The US Food and Drug Administration (FDA) has approved the first self-administered seasonal influenza vaccine – AstraZeneca’s FluMist. FluMist has been available in the US since 2003, but beginning next year, the nasal spray vaccine will also be available for self-administration. This approval increases the accessibility of seasonal influenza vaccines, and has the potential to […]
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mRNA vaccines lead next-generation efforts to combat H5N1 amid global outbreaks, says GlobalData

The H5N1 virus, known for its 50% human case fatality rate, has persisted globally for over two decades, causing thousands of infections. The recent outbreaks, including those affecting US dairy cows, have accelerated the development of next-generation vaccines, with mRNA vaccines stepping into the spotlight, aiming to replicate the success achieved during the COVID-19 pandemic, […]
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