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The Korean Ministry of Food and Drug Safety (MFDS) has recently given clearance to Hanmi Pharmaceutical to conduct Phase III trial for its Korean-optimized obesity candidate efpeglenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist. Against this backdrop, efpeglenatide is expected to get an edge in the domestic obesity market due to local trials, says GlobalData, a […]
PDS Biotech’s $500M upside for PDS0101 challenged by limited HPV positivity patient data, says GlobalData
PDS Biotech recently announced the initiation of a Phase III pivotal trial for its immunotherapy asset PDS0101 in recurrent/metastatic HPV-16+ head and neck squamous cell carcinoma (HNSCC). If approved, PDS0101 could reach $500 million in 8MM* sales in metastatic HNSCC, but the current lack of data for HPV-positive patients endangers the outcome of the Phase […]
Positive post hoc analysis of SCORED trial to bolster Inpefa use for heart failure, says GlobalData
At this year’s American Heart Association Scientific Session, positive results were presented from Lexicon Pharmaceuticals’ SCORED analysis of Inpefa (sotagliflozin), providing insight into the drug’s ability to significantly reduce the risk of heart failure (HF) in as little as three months. The post hoc analysis could be of high clinical value to cardiologists looking to […]
Positive phase III data could help position Ubrelvy in crowded migraine market, says GlobalData
AbbVie recently announced its publication in The Lancet showing that administration of Ubrelvy (ubrogepant) during the prodrome stage of a migraine can reduce the likelihood of a migraine attack developing. Ubrelvy is the first and only acute migraine treatment that has demonstrated Phase III data in the prodrome stage. These findings could grant Ubrelvy a […]
Sugemalimab approval in China makes it only second drug approved globally for ENKTL, says GlobalData
CStone Pharmaceuticals’ sugemalimab (Cejemly) has been approved by the China National Medical Products Administration (NMPA) for the treatment of relapsed or refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL) in October 2023. With this approval, sugemalimab becomes the first anti-PD-1/PD-L1 monoclonal antibody approved for r/r ENKTL globally and is expected to boost CStone’s presence in the […]
Oncology KRAS-targeting therapy market to exceed $4 billion by 2029, forecasts GlobalData
Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations are common in solid tumors, including lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. The introduction of KRAS inhibitors has become a significant advancement in the quickly developing area of oncology, providing hope in the battle against difficult solid tumors. The global market for KRAS-targeting drugs in […]
Arrowhead Pharmaceuticals’ plozarsiran and zodasiran hold potential to treat dyslipidemia, says GlobalData
At the American Heart Association (AHA) Scientific Sessions 2023 in Philadelphia, Arrowhead Pharmaceuticals unveiled the Phase II clinical data for plozasiran (ARO-APOC3) and zodasiran (ARO-ANG3). The Phase II SHASTA-2 study showed that plozasiran decreased APOC3 to -79%, triglycerides (TGs) to -74%, remnant cholesterol to -65% and increased high-density lipoprotein (HDL)-cholesterol (HDL-C) to 68% at 24 […]
Vertex Pharmaceuticals poised for dominance in global gene therapy market with first CRISPR approval, says GlobalData
Following the news that the UK Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics‘ Casgevy, marking the world’s first approval of a CRISPR-based gene editing therapy; Joselia Carlos, Medical Device Analyst at GlobalData, offers her view: “The approval of Casgevy for sickle cell anemia (SCA) and […]
FDA’s orphan drug designations increase for myelofibrosis drugs, reveals GlobalData
Concerns have been raised over the suitability of current FDA-approved treatments for myelofibrosis due to the negative associations with anemia. In response, the FDA has significantly increased the number of awarded orphan drug designations (ODDs) for myelofibrosis-indicated drugs in recent years. Since 2014, a total of 11 ODDs have been granted, with eight of them […]
FDA’s Fast Track designation for Altimmune’s pemvidutide reinforces use of GLP-1RAs in NASH, says GlobalData
In October 2023, the FDA granted Fast Track designation for Altimmune’s incretin mimetic, pemvidutide, in non-alcoholic steatohepatitis (NASH). Pemvidutide is a glucagon-like peptide 1 (GLP-1) glucagon receptor (GCGR) dual agonist peptide (GLP-1R/GCGR) currently in Phase IIb development for NASH (IMPACT trial) and for obesity (MOMENTUM trial). The Fast Track designation is supported by the data […]
Valneva single-dose chikungunya vaccine IXCHIQ poised to revolutionize global health, says GlobalData
Valneva recently announced the approval of IXCHIQ by the US Food and Drug Administration (FDA), marking the approval of the world’s first chikungunya vaccine. IXCHIQ is a single-dose, live-attenuated vaccine for use in adults 18 years of age and older, for the prevention of disease caused by the chikungunya virus (CHIKV). IXCHIQ has the potential […]
Diagnosed incident cases of multiple myeloma to grow at 1.87% AGR between 2022-2032 across 8MM, forecasts GlobalData
The diagnosed incident cases of multiple myeloma (MM) in the eight major markets (*8MM) are projected to increase from 80,305 in 2022 to 95,349 in 2032, equating to an annual growth rate (AGR) of 1.87%, forecasts GlobalData, a leading data and analytics company. Multiple myeloma is a hematologic cancer that forms in a type of […]
Tech skills shortage still a major challenge for healthcare industry, finds GlobalData
The shortage of talents that have specific digital skills continues to be a pressing issue for businesses since the lockdowns caused by COVID-19. Despite the growing demand for tech-savvy specialists, there is still a limited supply of individuals possessing digital skills, according to a recent survey by GlobalData, a leading data and analytics company. GlobalData’s […]
Mobile healthcare dominates as most commonly used component in decentralized clinical trials, reveals GlobalData
The COVID-19 pandemic catalyzed the adoption of decentralized clinical trials (DCTs) even though they have been in use for decades. DCTs offer the advantage of enabling patients to take part in clinical studies from the convenience of their homes, eliminating the need for them to travel to clinical sites. This not only reduces the burden on […]
Vast majority of healthcare professionals believed that COVID-19 had greatest impact on digital transformation, reveals GlobalData survey
Globally, 71% of healthcare industry professionals expressed that the COVID-19 pandemic had the greatest impact on digital transformation in the healthcare sector during the last few years, among other macro events, according to a survey* by GlobalData, a leading data and analytics company. GlobalData’s latest Thematic Intelligence report, ‘Digital Transformation and Emerging Technologies in the […]
First-in-class DLL3-targeting BiTE could be the next big player in small-cell lung cancer treatment, says GlobalData
Small cell lung cancer (SCLC), comprising 15% of lung tumors, is a highly aggressive form of malignancy. However, tarlatamab, a bispecific T-cell engager (BiTE) developed by Amgen, recently demonstrated potentially registrational data at the European Society for Medical Oncology (ESMO) 2023 Congress from the Phase II DeLLphi-301 trial. The drug may become a promising lifeline […]
Novartis blockbuster drug Tasigna faces sales decline as US patent expiry looms, observes GlobalData
Novartis’ blockbuster drug Tasigna (nilotinib) is set to lose its exclusive status in the US in January 2024. A pivotal treatment for chronic myeloid leukemia (CML), with forecasted 2023 sales of $1.8 billion, Tasigna faces a significant sales decline. The impending US patent expiry, coupled with a prior EU patent loss, is anticipated to result […]
Eli Lilly’s obesity drug Zepbound FDA approval intensifies competition with Novo Nordisk’s Wegovy, says GlobalData
Following the news that Eli Lilly’s Zepbound (tirzepatide) has received the US Food and Drug Administration (FDA) approval; Sara Reci, MSc, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers her view: “Tirzepatide, which is on the market for type 2 diabetes (T2D) as Mounjaro, has received the brand name Zepbound for […]
Zydus NCE drugs will see improved market penetration with new partnerships in India, says GlobalData
Zydus Lifesciences is one of the leading players to focus on new chemical entity (NCE) research and development in India. The company was able to successfully launch its homegrown NCE drugs Oxemia (desidustat) and Lipaglyn (saroglitazor) in the Indian market. It also partnered with Sun Pharma and Lupin to co-market desidustat and saroglitazar, respectively, in […]
Myasthenia gravis market to generate sales of $6.7 billion across 7MM by 2032, forecasts GlobalData
The market for myasthenia gravis (MG), an autoimmune and neuromuscular disease characterized by muscle weakness and fatigue, is set to experience a compound annual growth rate (CARG) of 8.3% across the seven major markets (7MM*) from $3 billion in 2022 to $6.7 billion in 2032, forecasts GlobalData, a leading data and analytics company. GlobalData’s latest […]