Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – May 2020
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19
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MonthMay 2020
Genmab Reports Results of Daratumumab Based Combination Therapy in P-III ANDROMEDA Study for Light-chain Amyloidosis
Shots: The P-III ANDROMEDA (AMY3001) study involves assessing of Daratumumab (SC) + cyclophosphamide + bortezomib + dexamethasone (CyBorD) vs CyBorD as monothx. in
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Roche Reports Updated Data of Alecensa in P-III ALEX Study for Patients with ALK-Positive Non-Small Cell Lung Cancer
Shots: The P-III ALEX study involves assessing of Alecensa vs crizotinib in 303 treatment-naïve patients in a ratio (1:1) with ALK+ NSCLC whose
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European Commission Waives the Takeda’s Commitment to Obtain Clearance on Shire’s Acquisition
Shots: EC has released Takeda from the obligation to divest SHP647 & its associated rights. Takeda will discontinue the clinical study of SHP647
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Eli Lilly’s Tauvid (flortaucipir F 18) Receives the US FDA’s Approval as the First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease
Shots: The safety and effectiveness of Tauvid imaging is evaluated in two clinical studies. In study 1, reader interpretations of premortem TAUVID scans
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Fresenius Kabi Signs an Agreement with Medec to Commercialize IDACIO (adalimumab, biosimilar) in Germany
Shots: Fresenius Kabi and Medec collaborated to offer IDACIO as an additional therapy option for rheumatologists and dermatologists to treat rheumatic illnesses. From
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AbbVie and Neurocrine’s Oriahnn Receive the US FDA’s Approval as the First Oral Therapy for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women
Shots: The approval follows P-III ELARIS UF-I and ELARIS UF-II studies assessing Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) vs PBO
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Zionexa And Petnet Solutions’ Cerianna (Fluoroestradiol F 18) Receive the US FDA’s Approval for Advancing Treatments in Metastatic Breast Cancer Patients
Shots: Cerianna (Fluoroestradiol F 18) is a novel FDA approved molecular imaging agent targeted for PET imaging for detection of estrogen receptor-positive lesions
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Atriva to Initiate P-II Clinical Study Evaluating ATR-002 for Treatment of Patients with COVID-19
Shots: Atriva will commence P-II study assessing ATR-002 vs PBO in hospitalized patients with moderate COVID-19, expected to be initiated in July’2020 ATR-002’s
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Fresenius Kabi Reports the US FDA’s Acceptance of BLA for its MSB11455 (biosimilar, pegfilgrastim)
Shots: The BLA submission is based on analytical, PK/ PD, safety and immunogenicity data from two clinical studies that demonstrated equivalent PK/ PD
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