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shankar besta

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FDA denial could delay launch of Minerva’s schizophrenia treatment roluperidone by at least two years, says GlobalData

Following the news that the FDA denied approval for Minerva Neurosciences for its roluperidone for the treatment of negative symptoms in patients with schizophrenia; Christie Wong, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “The FDA has issued a Complete Response Letter (CRL) for Minerva Neurosciences’ roluperidone. It follows a […]
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Voluntary pause of epetraborole Phase III enrollment setback for NTM late-stage pipeline, says GlobalData

AN2 Therapeutics recently announced a decision to voluntarily pause enrollment of the Phase III portion of the Phase II/III trial, EBO-301, in light of potentially lower than expected efficacy data obtained from the Phase II trial. EBO-301 (NCT05327803) is a pivotal trial evaluating the orally administered antibiotic epetraborole in patients with treatment-refractory Mycobacterium avium complex […]
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US businesses and employees face staggering $425.5 billion in economic costs from obesity and overweight in 2023, reveals GlobalData

Obesity and overweight are estimated to have caused a staggering $425.5 billion in economic costs to US businesses and employees in 2023, according to a report released by GlobalData , a leading data and analytics company. GlobalData’s latest report, ‘Assessing the Economic Impact of Obesity on Employers: Identifying Paths Toward Work Force Health and Well-Being,’ […]
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ViiV Healthcare and GSK’s Cabenuva could reduce poor treatment adherence in HIV, says GlobalData

Following the release of positive results for Phase III trial of ViiV Healthcare and GSK’s long-acting injectable antiretroviral treatment (ART) Cabenuva (cabotegravir + rilpivirine); Barbora Salcman, Infectious Disease Analyst at GlobalData, offers her view: “Cabenuva was approved by the FDA in January 2021, as a once monthly or once every other month complete HIV treatment […]
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SDx transformation redesigning enterprise fabric across sectors, says GlobalData

With the proliferation of software-defined everything (SDx) technologies such as Software-Defined Networking (SDN), Software-Defined Wide Area Networking (SD-WAN), and Software-Defined Storage, organizations across various sectors are experiencing transformative shifts in their digital infrastructure, states GlobalData, a leading data and analytics firm. Kiran Raj, Practice Head of Disruptive Tech at GlobalData, comments: “The surge in the […]
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Iovance’s Amtagvi to gain major share in melanoma treatment with first-to-market advantage, says GlobalData

Iovance Biotherapeutics’ Amtagvi has been introduced as the first FDA-approved T-cell immunotherapy for a solid tumor, employing a polyclonal tumor infiltrating lymphocyte (TIL) cell therapy. The personalized one-time cellular therapy is indicated for the treatment of adult patients with unresectable or metastatic melanoma who have previously received standard of care front-line PD-1 therapy and targeted […]
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Daiichi Sankyo poised to add another ADC blockbuster with datopotamab deruxtecan for non-squamous NSCLC, says GlobalData

Following the news that the FDA has accepted the BLA submission for datopotamab deruxtecan in non-squamous NSCLC patients; Israel Stern, MSc,  Oncology & Hematology Analyst at GlobalData, a leading data and analytics company, offers his view: “As sales for Daiichi Sankyo’s and AstraZeneca’s HER2+-targeting antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) continue to skyrocket, the companies […]
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