Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
Clinical Trial Corner: The Russia-Ukraine War’s Impact on Global Industry Clinical Trials
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT's VP of Global Clinical Strategy. As I wrote in my introduction to this blog series, my aim here is to introduce and dissect one of the pertinent topics in the area of...
BIDMC and Deerfield Management Announce Research Collaboration to Accelerate the Creation and Development of Therapeutics
Beth Israel Deaconess Medical Center (BIDMC) and Deerfield Management, a healthcare investment firm, announce a research collaboration to accelerate discovery of novel therapeutics. Deerfield will provide up to $130 million along with additional scientific and...
Ionis presents positive results from Phase 3 NEURO-TTRansform study at International Symposium on Amyloidosis
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) presented positive results from a planned 35-week interim analysis of the Phase 3 NEURO-TTRansform study of Ionis and AstraZeneca's eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy...
Bertis Announces Proteomic Based Research Results of New Biomarker for Ovarian Cancer Diagnosis
Bertis, a proteomics-based precision medicine technology development company (CEOs Dong-young Noh, Seung-man Han), announced that the research results of their search for protein biomarkers for early diagnosis of high-grade serous ovarian cancer (HGSOC) were published...
New Liquid Embolic Multi-Center Trial Successfully Enrolls Final Patient
Fluidx Medical announces completion of trial enrollment for its novel embolic device, GPX. In this multi-center trial, GPX was used to treat a variety of primary and metastatic tumors, renal adenoma tumors, and a range of other arterial and venous applications. GPX...
Clinical Trial Corner: Dr. Vladimir Misik Introduces CSOFT’s Newest Series
After participating in CSOFT’s Coffee and Conversations podcast in 2021, I felt honored being asked by Shunee Yee, the President and CEO of CSOFT and CSOFT Health Sciences, to write a blog series on pertinent topics in global clinical trials by showcasing my expertise...
Sanofi Wins FDA Approval for First ASMD Drug
Sanofi announced that Xenpozyme (olipudase alfa-rpcp) won FDA approval for adult and pediatric patients with the rare genetic disease acid sphingomyelinase deficiency (ASMD), often referred to as Niemann-Pick disease. In its announcement, the FDA noted that...
ImmunoGen Provides Update on Pivotal CADENZA Study of Pivekimab Sunirine in Frontline Blastic Plasmacytoid Dendritic Cell Neoplasm
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, provided an update on the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in blastic plasmacytoid dendritic cell neoplasm...
FDA Allows Patient Enrollment to Resume in Monotherapy Dose Escalation of Emavusertib in TakeAim Leukemia Study
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, announced that the U.S. Food and Drug Administration (FDA) has notified Curis that it may resume enrollment of additional patients in...
iCAD Customers in the U.S. and Europe Increasingly Adopting Company’s Full Suite of Breast AI Technologies via Subscription Model
iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, announced that a growing number of hospitals and imaging centers in the U.S. and Europe are increasingly choosing to adopt iCAD’s Breast AI...
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