Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 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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MonthJune 2020
Celltrion’s Remsima SC (biosimilar, infliximab) Receives CHMP’s Positive Opinion for an Additional Five Indications Including Inflammatory Bowel Disease and Ankylosing Spondylitis
Shots: CHMP has recommended expanding the existing marketing authorization for Remsima SC for five indications that include AS, CD, UC, PsA and psoriasis.
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Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin) Receives the US FDA’s Approval for Early and Metastatic HER2-Positive Breast Cancer
Shots: The approval is based on P-III FeDeriCa study which involves assessing of Phesgo (SC) + CT vs Perjeta (pertuzumab, IV) & Herceptin
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AstraZeneca and MSD’s Selumetinib Receive MHLW’s Orphan Drug Designation for Neurofibromatosis Type 1 in Japan
Shots: The ODD designation follows P-I/II SPRINT Stratum 1 study assessing Selumetinib (bid) as monothx. in pediatric patients with NF1-related inoperable PNs The
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Bharat Biotech to Initiate Clinical Trials Evaluating Covaxin (India’s First COVID-19 Vaccine) in July 2020
Shots: Bharat Biotech has received DCGI approval to conduct P-I & II clinical studies assessing Covaxin, developed in collaboration with ICMR and NIV.
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Abbott Integrates its CGM Technology with Tandem’s Insulin Delivery System for Improving Diabetes Management
Shots: The companies collaborated to develop & commercialize integrated diabetes solutions that combine Abbott’s FreeStyle Libre CGM technology with Tandem’s t:slim X2 pump
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Gilead Unveils the Price of Remdesivir as $390 per Vial in Developed Countries
Shots: Gilead will price its COVID-19 treatment at $390/ vial in the US and other developed countries, with a 5days treatment course of
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Samsung Bioepis’ Aybintio (biosimilar, bevacizumab) Receives CHMP’s Positive Opinion to Treat Multiple Cancer Indications
Shots: The CHMP has recommended the approval of Aybintio in the EU to treat mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube and
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Kyowa Kirin’s FKB327 (biosimilar, adalimumab) Receives the MMA Approval in Japan
Shots: FKB327 (biosimilar, adalimumab) is an injectable medication that involves inhibition of Tumor Necrosis Factor (TNF) blocks the inhibition of activity, thereby reducing
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Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan
Shots: The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as
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