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Following the news that the National Institute for Health and Care Excellence (NICE) has recommended the first new treatment for incurable cervical cancer in 14 years; James Donagher, Oncology & Hematology Analyst at GlobalData, offers his view: “NICE has recommended Merck’s Keytruda (pembrolizumab) in combination with chemotherapy for use in patients with persistent, recurrent, or […]
NMPA approval for Likang Life personalized neoantigen-targeted vaccine LK101 injection sets stage for exciting developments in cancer treatment, says GlobalData
Likang Life Sciences has recently been granted implied approval by the National Medical Products Administration (NMPA) for the clinical trial of its innovative personalized neoantigen-targeted vaccine LK101 Injection for advanced solid tumors. This breakthrough marks the first of its kind in China and represents a significant milestone in innovative drug discovery pathways for cancer treatment. […]
World Tuberculosis Day reminds us of major global burden, says GlobalData
World Tuberculosis (TB) Day is observed annually on 24 March to raise awareness about TB and efforts to end the global epidemic. TB is reportedly the second leading cause of death worldwide by an infectious disease – only recently moving from first to second place, behind COVID-19. Over the past 10 years, 668 clinical trials […]
Dr. Reddy’s focuses on differentiated portfolio in key therapy areas as part of India growth strategy, says GlobalData
Dr. Reddy’s Laboratories (DRL) has been strategizing to become a top company in the Indian pharmaceutical market. The company’s focus is on building strong brands and excelling in selected therapy areas. In line with this goal, the company has been divesting non-core brands that do not align with its growth objectives and acquiring product rights […]
Prometheus’ PRA023 holds significant advantage over all therapies for Crohn’s Disease, says GlobalData
At the European Crohn´s and Colitis Organisation (ECCO), Prometheus Bioscience presented results from its Phase 2a APOLLO-CD clinical trial of PRA023 in Crohn’s Disease (CD). The presentation highlighted the efficacy and safety of PRA023, an anti-TL1A asset, in the small sample size (N=50) of CD patients. The area of particular interest from this presentation was […]
Pfizer acquisiton of ADC trailblazer Seagen a worthy investment, says GlobalData
Pfizer recently announced the acquisition of Seagen, a US-based biotech with four marketed oncology medicines and a rich pipeline, for $43 billion. If completed, the deal will be the largest in the sector since AbbVie scooped up Allergan for $63 billion in 2019. Seagen specializes in developing antibody-drug conjugates (ADCs) that will complement Pfizer’s large […]
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 […]
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 […]
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 […]
Tumor agnostic label may be on the horizon for blockbuster Enhertu, says GlobalData
Daiichi Sankyo and AstraZeneca recently announced positive results from the ongoing DESTINY-Pan Tumor02 Phase II study, which included 268 patients with biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and other rare cancers, for all of whom no curative therapy was available. The study revealed that Enhertu met the prespecified target for the primary endpoint of […]
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 […]
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 […]
Diagnosed prevalent cases of systemic lupus erythematosus in 7MM to reach 0.58 million by 2031, estimates GlobalData
The diagnosed prevalent cases of systemic lupus erythematosus (SLE) in the seven major markets (7MM*) are projected to increase from 0.55 million in 2021 to 0.58 million in 2031, registering an annual growth rate (AGR) of 0.51%, estimates GlobalData, a leading data and analytics company. SLE is a complex multi-system autoimmune disease in which the immune […]
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 […]
Price cap move will help Eli Lilly remain dominant player in insulin market, says GlobalData
Eli Lilly recently announced that it will reduce the price of its insulin Humalog by 70% in the US and cap the out-of-pocket cost for those on commercial insurance at $35 per month. This is the second time Lilly has significantly reduced the cost of its insulin after lowering the list price of Humalog by […]
New RSV therapies may accelerate the emergence of drug-resistant strains, says GlobalData
Given the large market potential and high unmet need for new respiratory syncytial virus (RSV) therapies, drug developers have been focused on new vaccine and monoclonal antibody (mAb) development. A vaccine for RSV has yet to be approved anywhere around the globe. However, recent advances in the field have led to the priority review of […]
Diagnosed prevalent cases of ulcerative colitis to surpass two million in 2031 across 8MM, forecasts GlobalData
The diagnosed prevalent cases of ulcerative colitis (UC) in the eight major markets (*8MM) are projected to increase from 1.9 million cases in 2021 to 2.1 million in 2031, equating to an annual growth rate (AGR) of 0.63%, forecasts GlobalData, a leading data and analytics company. Ulcerative colitis is an inflammatory bowel disease (IBD) characterized […]
Clene’s CNM-Au8 could target vision problems in multiple sclerosis, says GlobalData
Clene has recently presented updated trial results for its Visionary MS Phase II trial, in which its lead pipeline candidate, CNM-Au8, is being investigated as a treatment for relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy*. The agent has a first-in-class mechanism of action within the MS portfolio, as it is the first […]
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 […]
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 […]