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GlobalData

Pharma

Opdivo to replace Herceptin as the distinguished leader in gastric and gastro-oesophageal cancer following label expansions, says GlobalData

Opdivo is set to become the market leader in gastric in gastro-oesophageal cancer following the latest data from two label expansion trials, which were noted to have met their primary endpoints. GlobalData expects Opdivo’s label expansions to gain approval in mid-2021 and revolutionize this indication as the first targeted therapy available in the adjuvant setting […]
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Russia’s lack of Phase III data for COVID-19 vaccine leaves some unconvinced of safety and efficacy, says GlobalData

Following the news that Russia has approved the first COVID-19 vaccine; Philipp Rosenbaum, PhD, Senior Infectious Diseases Analyst at GlobalData, a leading data and analytics company, offers his view: “The available clinical trial data for Russia’s COVID-19 vaccine, comprising 38 trial participants that have been followed for two months, is simply not enough to convince […]
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Although Lilly’s monoclonal antibody could be efficacious against COVID-19, recruitment could be slow, says GlobalData

Following the news of Eli Lilly and Company initiating a Phase III trial for their monoclonal antibody, LY-CoV555, for the prevention of COVID-19 in nursing home residents; Arafa Salam, PhD, Infectious Diseases Analyst at GlobalData, a leading data and analytics company offers her view: “Although the use of mobile research facilities for clinical trials may […]
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AstraZeneca continues to take strategic steps towards differentiating Forxiga from SGLT-2 inhibitor competitors, says GlobalData

AstraZeneca’s Farxiga (dapagliflozin) is expected to significantly strengthen its presence in the the sodium-glucose co-transporter-2 inhibitor (SGLT-2I) class of the cardiovascular and metabolic arena after recent findings suggested the drug can both reduce cardiovascular (CV) risk and decrease the risk of new-onset diabetes in HF-REF patients. Key opinion leaders (KOLs) interviewed by GlobalData have expressed […]
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Continued collection of longitudinal data suggested to assess immune response that COVID-19 triggers in pregnant women, says GlobalData

Recent study findings from the US Centers for Disease Control and Prevention (CDC) suggest there may be a difference in disease severity when comparing pregnant and nonpregnant women with COVID-19. Understanding the outcomes of pregnancy in COVID-19-positive women could prevent adverse outcomes on a large scale, and more data collection on pregnant women with COVID-19 […]
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Licensing agreement deals decline in rare diseases space, says GlobalData

Licensing agreements are decreasing in the rare disease space in favor of more complex collaborations and partnerships. Indeed, of the strategic alliances formed by the top ten bio/pharma companies (by market cap) in the last year, 17% were in the rare diseases space, according to the GlobalData Pharmaceutical Intelligence Center Deals Database. Madeleine Roche, Associate […]
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Monjuvi approval in relapsed/refractory DLBCL could lead home run for Morphosys/Incyte against big players, says GlobalData

Following the FDA’s recently granted accelerated approval for Morphosys and Incyte’s CD19 targeting antibody Monjuvi (tafasitamab), Morphosys and Incyte partnership now pushes forward to compete with Roche’s well-established diffuse large B-cell lymphoma (DLBCL) franchise as the go-to option in the second line and beyond treatment setting. Monjuvi could represent a safer, more effective, and affordable […]
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ACTIV initiative could help speed up COVID-19 therapeutics and vaccines by making research more efficient

With the rapid proliferation of clinical trials addressing COVID-19, the US National Institutes of Health (NIH) launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, which could help speed up the delivery of therapeutics, says GlobalData, a leading data and analytics company. The ACTIV initiative is a public-private partnership effort to address the COVID-19 […]
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17 of 20 top pharmaceutical companies be revenue reported YoY growth in 2019, says GlobalData

As another great year for the innovation bio/pharma industry, 2019 saw 17 of the top 20 mega cap players reporting YoY revenue growth, according to GlobalData, a leading data and analytics company. Madeleine Roche, Associate Pharma Analyst at GlobalData commented, “One winner was Takeda, which saw more than 50% YoY revenue growth. The company’s significant […]
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SC Remsima will need cost-effective pricing to further erode the shares of Remicade, says GlobalData

Following the news that the first subcutaneous (SC) formulation of Celltrion’s Remsima (infliximab-dyyb/CT-P13) was granted marketing authorization by the European Commission (EC) for all indications in adults for which the intravenous formulation is also approved*, GlobalData notes that, in order for Celltrion to further erode market share of its rival Remicade – and other anti-TNF […]
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IMU-838 could be alternative treatment option for RRMS patients who are ineligible with mAbs, says GlobalData

Following the publication of positive top-line data from the Phase II EMPhASIS trial of IMU-838 (vidofludimus calcium) in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) by Immunic; Alessio Brunello, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers his view: “Patients who are ineligible for treatments with monoclonal antibodies (mAbs) might benefit from […]
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Remdesivir and favipiravir price regulation required to safeguard patients’ interest in India, says GlobalData

Regulatory bodies such as the National Pharmaceutical Pricing Authority (NPPA) and the Drug Controller General of India (DCGI) are keeping a close eye on remdesivir and favipiravir amid the COVID-19 pandemic to safeguard patients’ interest around pricing, says GlobalData, a leading data analytics and research company. The Indian Council of Medical Research (ICMR) has recently […]
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Evidence that COVID-19 in pregnant women could mimic preeclampsia can help with patient management but more data needed to prove link, says GlobalData

Following the news that there is evidence that COVID-19 infection in pregnant women can exhibit signs that mimic a severe form of preeclampsia such as hemolysis, elevated liver enzymes and low platelet count (HELLP), GlobalData notes that while this evidence can be taken into consideration during the evaluation of high-risk patients presenting signs of preeclampsia […]
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Novaliq’s CyclASol could become preferred cyclosporine formulation if pivotal trial succeeds

Novaliq recently announced its agreement with the US Food and Drug Administration (FDA) regarding the second registrational trial ESSENCE-2 for its late-stage therapy, CyclASol, for dry eye syndrome (DES). This is a positive development for the DES market, particularly due to its favorable tolerability profile, according to GlobalData, a leading data and analytics company. ESSENCE-2 […]
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Biocon and Voluntis deal aims to personalize treatment for type 2 diabetic patients on insulin, says GlobalData

Biocon Sdn. Bhd., Malaysia, a subsidiary of Biocon Biologics, and digital therapeutics company Voluntis have recently announced a global collaboration agreement to develop and distribute FDA-cleared and CE-marked digital therapeutic product ‘Insulia’ for type 2 diabetes (T2D) patients across several markets. The deal will make Insulia available to a large number of Biocon’s biosimilar insulin […]
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