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.
Sermonix Pharmaceuticals Announces Results of Phase 2 Study of Lasofoxifene vs. Fulvestrant in Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation
Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, announced results of its signal-seeking Evaluation of Lasofoxifene in ESR1...
Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren’s Syndrome Meets Primary Endpoint
Horizon Therapeutics plc (Nasdaq: HZNP) announced that its Phase 2 trial evaluating dazodalibep for the treatment of Sjögren’s syndrome met the primary endpoint in patients with moderate-to-high systemic disease activity as defined by the European Alliance of...
Alnylam Presents Positive Results from the APOLLO-B Phase 3 Study of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive results from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR)...
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...
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