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GlobalData

Pharma

AbbVie Parkinson’s drug ABBV-951 faces few hurdles before FDA approval, says GlobalData

Following the news that AbbVie received a complete response letter (CRL) from the FDA, concerning its new drug application for ABBV-951 (foscarbidopa/foslevodopa) to treat motor fluctuations in patients with advanced Parkinson’s disease; Christie Wong, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “Although levodopa is a highly effective drug for […]
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Serum Institute of India likely front-runner to win supply of HPV vaccines for Universal Immunization Program, says GlobalData

India is preparing to include human papillomavirus (HPV) vaccines as part of the government driven public immunization program popularly known as the “Universal Immunization Program (UIP)”. The Indian government will float a global tender in April 2023 to procure HPV vaccines. Against this backdrop, domestic player the Serum Institute of India (SII) is expected to […]
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Race for first-to-market NASH therapy heats up, says GlobalData

Following the FDA’s announcement to review Intercept Pharmaceuticals’ resubmission of its new drug application (NDA) for obeticholic acid (OCA) in patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH); Sravani Meka, Senior Immunology Analyst at GlobalData, a leading data and analytics company, offers her view: “The race for a first-to-market therapy in NASH has […]
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Rivaroxaban holds potential to become new standard of care for atrial fibrillation patients with advanced CKD, says GlobalData

At the 72nd annual American College of Cardiology (ACC) meeting, new real-world data was presented from the XARENO study demonstrating that the new oral anticoagulant (NOAC) Xarelto (rivaroxaban) was associated with a reduced risk of adverse kidney outcomes in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD), compared to vitamin K […]
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Long road ahead for non-statin therapies in Australia dyslipidemia treatment space, says GlobalData

Esperion Therapeutics’ non-statin therapy “bempedoic acid” has shown modest results in reducing the risk of major cardiovascular events in statin-intolerant patients in the cholesterol lowering via bempedoic acid, an ACL-inhibiting regimen (CLEAR Outcomes) trial. As a result, there is substantial room for improvement in this space as a potential approval is expected in Australia in […]
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Reduced pulmonary vascular resistance demonstrated in A DUE Study, says GlobalData

At this year’s American College of Cardiology (ACC) Scientific Session, Johnson & Johnson has presented positive results from “A DUE” analyses of Opsynvi (macitentan and tadalafil), providing insight into the drug’s ability to reduce pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH). Against this backdrop, the PAH market across the seven major […]
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Merck’s MK-0616 holds potential to become first oral PCSK9 inhibitor in dyslipidemia market, says GlobalData

Merck recently unveiled the Phase II clinical data for MK-0616, an investigational oral cholesterol-lowering drug, revealing that it significantly reduced low-density lipoprotein (LDL) cholesterol in adults by 41.2% at the lowest dose of 6mg and 60.9% at the highest dose of 30mg at week 8 in patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD), with […]
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Novel pipeline agents to bring innovation to ulcerative colitis market, says GlobalData

Inflammatory bowel disease (IBD) refers to two autoimmune diseases that cause intestinal inflammation: Crohn’s disease (CD) and ulcerative colitis (UC). The market for the UC is filled with several different treatment options, and the pipeline is relatively strong. Novel agents such as toll-like receptor 9 (TLR9) cobitolimod and microRNA 124 (MIR124) inhibitor obefazimod are expected […]
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Terran Biosciences novel PCT patent application shows growing interest in psilocin therapies, says GlobalData

Terran Biosciences has recently published a PCT patent application for unnamed orally administered novel psilocin prodrugs. The biotech platform company joins a growing number of companies developing psilocybin-based drugs, including MindMed and Compass Pathways, two leading companies in the psychedelic therapy space. Terran’s patent filing shows that interest in psilocin therapies is growing, says GlobalData, […]
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Significant unmet need remains for disease-modifying therapies in Alzheimer’s market despite two recent approvals, says GlobalData

The current treatments for Alzheimer’s disease (AD) consist mostly of medications that are aimed at treating the symptoms of the disease. A novel disease-modifying therapy (DMT) that can demonstrate significant efficacy in clinical trials could revolutionize the AD market in a way that the anti-amyloid-beta (Aβ) monoclonal antibodies (mAbs) have been unable to do thus […]
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Nubeqa approval to boost Bayer’s presence in prostate cancer market in Japan, says GlobalData

Following the news that Bayer’s androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) and docetaxel has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for use in patients with metastatic prostate cancer; James Donagher, Oncology & Hematology Analyst at GlobalData, offers his view: “Due to Japan’s ageing population, […]
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Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData

The Central Drugs Standard Control Organisation (CDSCO) approval of AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin heralds a new era of treatment for biliary tract cancer (BTC) in India, where chemotherapy has been the only choice for over a decade. With no potential competition in near future, the British-Swedish pharma major certainly has […]
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