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...
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...
Journal of Pharmaceutical Analysis Articles Highlight the Potential of Nanotechnology to Detect Clinically Useful Biomolecules
The advent of nanotechnology has led to exciting innovations across all fields of healthcare. While drug delivery and disease treatment are the most discussed medical applications of nanotechnology, recent studies published in Volume 12 Issue 3 of Journal of...
Medical Patent Application Translations: Meeting International Language Requirements for Patent Applications
How can medical device patent application translations help companies maintain a competitive edge in global markets? While medical device patents help prevent other companies from importing, replicating, or using your device domestically, they need to be validated in...
Baxter Broadens Efforts to Increase Awareness, Education and Support of Kidney Health in Black Communities
Baxter International, Inc. (NYSE:BAX), a global medtech leader, announces the national expansion of its partnership with international not-for-profit organization The Links, Incorporated (The Links) to continue bringing awareness and resources for the disproportionate...
SELLAS Life Sciences’ Highly Selective CDK9 Inhibitor, GFH009, Demonstrates Cancer Cell Growth Inhibition in Preclinical In Vitro Model of Neuroendocrine Prostate Cancer Cell Line
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, announced results from a new preclinical in vitro study...
Todos Medical Initiates MonkeyPox Diagnostic Case Studies After Being Approached by 4 Patients, Including 3 Women
Todos Medical Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, announced that its Atlanta-area CLIA/CAP-certified clinical laboratory Provista Diagnostics, Inc. has initiated a MonkeyPox diagnostic case study series evaluating...
Teleflex to Expand Its Surgical Portfolio with Differentiated Stapling Technology for Bariatric Surgery Signs Definitive Agreement to Acquire Standard Bariatrics
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, announced it has entered into a definitive agreement to acquire Standard Bariatrics, Inc. which has commercialized an innovative powered stapling technology for bariatric surgery....
Sorrento Therapeutics Announces China National Medical Products Administration (NMPA) IND Clearance of STI-1558, An Oral Mpro Inhibitor for Phase I Trial In COVID-19 Patients
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced the NMPA clearance of a Phase I study of its oral main viral protease (Mpro) inhibitor, STI-1558, in subjects with COVID-19 in a MAD study in China. In a previously announced Australia Phase I study in...