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Pharma

Total prevalent cases of female infertility to decrease at 0.4% AGR in 7MM during 2023-33, forecasts GlobalData

The total prevalent cases of female infertility in the seven major markets (*7MM) are projected to decrease from 16,732,165 cases in 2023 to 16,053,363 cases in 2033, registering a negative annual growth rate (AGR) of 0.41%, forecasts GlobalData, a leading data and analytics company. GlobalData’s latest report, “Female Infertility – Epidemiology Analysis and Forecast to […]
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Eli Lilly’s Kisunla approval to heat up competition in the Alzheimer’s market, says GlobalData

Following the news that the FDA has approved Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Kisunla (donanemab) for the treatment of patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD); Philippa Salter, Managing Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “After facing several delays, Lilly’s Kisunla […]
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EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD, says GlobalData

Following the European Medicines Agency (EMA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on 03 July 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 EMA as the first biologic for uncontrolled chronic […]
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Amylyx looks to cover financial gap left by Relyvrio with avexitide deal, says GlobalData

In June, Amylyx Pharmaceuticals acquired the rights to Eiger Biopharmaceuticals’ experimental glucagon-like peptide-1 (GLP-1) receptor antagonist, avexitide, for $35.1 million. Avexitide was previously developed for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). The acquisition is a notable strategic action by Amylyx following the failure of its lead amyotrophic lateral sclerosis (ALS) therapy, Relyvrio (sodium phenylbutyrate […]
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Asthma inhaler price cap in US may help pharma companies to secure more loyal customer base, says GlobalData

In the US, a recent initiative by major pharmaceutical companies to cap the cost of asthma inhalers at $35 per month marks a significant development in healthcare affordability and accessibility. Overall, the price cap on asthma inhalers represents a multifaceted victory. For patients, it means improved access to life-saving medications and a reduction in financial […]
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FDA approval of Verona’s Ohtuvayre to transform US COPD market for severe exacerbators, says GlobalData

Following the Food and Drug Administration’s (FDA) approval of Verona Pharma’s Ohtuvayre (ensifentrine) yesterday evening in the US: Asiyah Nawab, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view: “Ohtuvayre, a first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor, has great potential to dominate the market for moderate to severe exacerbators with chronic […]
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Everest Medicines Nefecon to transform IgAN treatment in China and Asia, says GlobalData

China-based Everest Medicines has recently launched Nefecon (budesonide DR) to treat primary immunoglobulin A nephropathy (IgAN) in China. It is the first approved medicine for IgAN by China’s National Medical Products Administration (NMPA). It represents an innovative treatment option for IgAN patients with more rapid disease progression compared to the American and European populations, says […]
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CAR T-cell assets for SLE and LN diseases hold potential for growth with China emerging as key player, says GlobalData

At the recent European Alliance of Associations for Rheumatology (EULAR) 2024 conference, industry sponsors presented preliminary data from ongoing, early-stage clinical trials evaluating CAR T-cell assets in autoimmune diseases, including systemic lupus erythematosus (SLE) and lupus nephritis (LN). While the overall results gave early indications of the potential ability of CAR T-cell assets in achieving […]
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FDA approval of CAPVAXIVE will enhance protection against pneumococcal disease in older adults, says GlobalData

The FDA has approved Merck’s CAPVAXIVE (pneumococcal 21-valent conjugate vaccine, originally known as V116), for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older. This is the first pneumococcal vaccine that is specifically designed to protect against serotypes which particularly infect older adults. The vaccine will likely become […]
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Niemann Pick Type C market sales across 3MM to reach $220 million in 2031, forecasts GlobalData

Niemann Pick Type C (NPC) is a rare progressive genetic disorder, characterized by the accumulation of dysfunctional proteins causing lysosomal function impairment. Patients can experience diverse symptoms, from hepatosplenomegaly, to neurological disorders, to respiratory failure. New medicines for NPC are expected to launch in the three major markets (3MM: US, Germany and UK) in the […]
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Bayer’s BAY2927088 to face intense competition in EGFR-mutant but limited competition in HER2-exon 20 mutant NSCLC market in China, says GlobalData

Bayer AG’s BAY2927088 recently received the Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Following approval, BAY2927088 is expected to face intense competition in the epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) but limited competition in the human epidermal growth factor […]
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Vertex could solidify dominance in cystic fibrosis market with vanza triple approval, says GlobalData

With the submission of regulatory marketing applications for its once-daily vanzacaftor triple, also known as the vanza triple program (vanzacaftor/tezacaftor/deutivacaftor) with the European Medicines Agency (EMA) and the US FDA, Vertex Pharmaceuticals is expected to hold its lead in the development of therapies for the treatment of cystic fibrosis (CF). Approval and success of vanza […]
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Beacon Therapeutics’ AGTC-501 holds potential to become first gene therapy in XLRP space, says GlobalData

Beacon Therapeutics initiated the final leg of the race for its lead asset, AGTC-501 (laruparetigene zovaparvovec), announcing recently that the company has treated its first patient in the pivotal trial, VISTA. Currently, the only retinitis pigmentosa therapy on the market is Spark Therapeutics’ Luxturna (voretigene neparvovec), a retinoid isomerohydrolase activator, indicated for patients with confirmed […]
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Tapinarof may mark Dermavant’s first atopic dermatitis approval, says GlobalData

Dermavant’s VTAMA (tapinarof), a nonsteroidal, topical AhR-modulating agent, achieved positive Phase III trial results in atopic dermatitis patients aged two and above, leading to FDA acceptance of its supplemental new drug application (sNDA). The promising results may bring Dermavant’s VTAMA closer to market authorization and will be its first atopic dermatitis marketed drug, subject to […]
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China’s Innovent holds potential to change pancreatic cancer treatment landscape with bispecific antibody IBI389, says GlobalData

China-based Innovent Biologics recently presented Phase I study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results from the Phase I study (NCT05164458) of IBI389 demonstrated promising efficacy in pancreatic ductal adenocarcinoma (PDAC) and the bispecific […]
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