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Eiger to halt Phase 3 LIMT-2 trial of Peginterferon Lambda in CHD patients
The decision to discontinue the trial was based on the recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly safety review
Sempre Health Secures $20 Million in Funding From Cencora Ventures, Echo Health Ventures, and Others
Investment will support rapid growth of Sempre’s life sciences and payer networks and expansion into adjacent product areas
AbbVie’s SKYRIZI Met All Primary and Secondary Endpoints Versus Stelara in Head-to-Head Study in Crohn’s Disease
SEQUENCE, a Phase 3 head-to-head study (study drug open-label and efficacy assessment blinded) compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease who have failed one or more anti-TNFs
US FDA clears BioLineRx’s Aphexda for HSC mobilisation in multiple myeloma patients
The FDA approval was supported by findings from the two-part, Phase 3 GENESIS trial in which the combination met the primary endpoint with a high degree of statistical significance
Sumitomo Pharma Announces Positive Topline Results from Phase 3 Clinical Studies Evaluating Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia
Vibegron Met Both Co-Primary Endpoints Demonstrating Statistically Significant Reductions in Daily Micturition and Urgency Episodes, Compared to Placebo at Week 12
Janssen submits MAA to EMA for Erdafitinib approval in urothelial cancer treatment
The MAA is backed by findings from Cohort 1 of the randomised, controlled, open-label, multicentre Phase 3 THOR trial, which compares the effectiveness and safety of erdafitinib and chemotherapy
Policlinico Gemelli, Palantir to leverage AI to advance data science for healthcare
The collaboration aims to introduce digital medicine research solutions that harness the power of artificial intelligence (AI) to enhance patient care and health outcomes
US FDA Grants Emergency Use Authorisation For ViraDx™
Lumos Diagnostics (ASX: LDX), (“Lumos” or the “Company”) a leader in rapid, point-of-care (POC) diagnostic technologies, is pleased to announce that the US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) and a CLIA Waiver (Clinical Laboratory Improvement Amendments) for the ViraDx test which is a combined COVID-19/Flu A/Flu B rapid POC test.
Citius Pharmaceuticals Receives Regulatory Guidance from the US FDA regarding the Planned Resubmission of the BLA for LYMPHIR
Resubmission to FDA planned for early 2024
BioGX Expands Xfree Respiratory PCR With COVID-19/Flu A/Flu B Multiplex, Group A Streptococcus, Mycoplasma Pneumoniae
BioGX, a global provider of molecular diagnostic solutions, announces the availability of three new Xfree™ Direct-Sample-to-Answer PCR multiplexes for the detection of Group A Streptococcus, Mycoplasma pneumoniae and Flu A, Flu B, COVID-19 N1/RdRp. Xfree Flu A, Flu B, COVID-19 and Group A Streptococcus were previously CE-IVD marked while Mycoplasma pneumoniae is available as research use only. Laboratories can request custom manufactured formats for high-throughput use that may be validated for their intended use on a variety of real-time PCR platforms including, the BioGX pixl™, Applied Biosystems 7500, ThermoFisher QuantStudio and Bio-Rad CFX Touch.