Avance Clinical Expands Global Site Partnership Network with 2,000 North American Sites, Enhancing Biotech Clinical Development

Avance Clinical, the award-winning market-leading CRO for biotechs, announced today that 2,000 clinical sites across North America had joined the Avance ...

September 02, 2024 | Monday | News
Sanofi’s Tolebrutinib Shows First Disability Reduction in Phase 3 nrSPMS Study

Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary...

September 02, 2024 | Monday | News
Johnson & Johnson Submits First Global Application for Nipocalimab, Pioneering Treatment for Generalized Myasthenia Gravis

Johnson & Johnson  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for nipocali...

August 30, 2024 | Friday | News
Merck KGaA Initiates Global Phase III MyClad Trial for Potential First Oral Treatment of Generalized Myasthenia Gravis

MyClad is a global Phase III study evaluating the efficacy and safety of cladribine capsules for the treatment of generalized Myasthenia Gravis (...

August 29, 2024 | Thursday | News
Novartis’ Leqvio® (inclisiran) Outperforms Placebo and Ezetimibe in Phase III V-MONO Study for LDL-C Reduction

Phase III V-MONO study met its primary endpoints, demonstrating superiority of Leqvio (inclisiran) monotherapy vs both placebo and ezetimibe in LDL-C r...

August 29, 2024 | Thursday | News
AC Immune's Partner LMI Receives FDA Fast Track Designation for PI-2620 in Alzheimer's and Other Neurodegenerative Diseases

  PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMI This Fast Track designation applies across Al...

August 28, 2024 | Wednesday | News
LIXTE Biotechnology and Netherlands Cancer Institute Dose First Patient in Roche-Supported Trial for Metastatic Colorectal Cancer

LIXTE Biotechnology Holdings, Inc. announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer In...

August 27, 2024 | Tuesday | News
BeiGene's Investigational BTK Degrader BGB-16673 Receives FDA Fast Track Designation for Relapsed CLL/SLL

BeiGene, a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an ...

August 27, 2024 | Tuesday | News
Fujitsu Launches Global Initiative to Attract Clinical Trials to Japan and Combat 'Drug Loss' with New Medical Data Ecosystem

Fujitsu announced that it will begin initiatives to attract global clinical trials to Japan and tackle the 'drug loss' issue by working with pharmaceutic...

August 27, 2024 | Tuesday | News
FDA Accepts Application for Opdivo Plus Yervoy as First-Line Treatment for Unresectable Hepatocellular Carcinoma

Acceptance based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo (nivolumab) plus Yervoy(ipilimumab) compared to in...

August 22, 2024 | Thursday | News
Pfizer and BioNTech's Ambitious Combo Vaccine Shows Promise but Faces Hurdles in Phase 3 Trial

In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicit...

August 19, 2024 | Monday | News
Phanes Therapeutics Secures FDA Orphan Drug Designation for PT217 in Treating Neuroendocrine Carcinoma

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today th...

August 19, 2024 | Monday | News
Incyte Announces Positive Phase 3 Trial Results for Tafasitamab in Relapsed or Refractory Follicular Lymphoma

Incyte  announces positive topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®), a...

August 16, 2024 | Friday | News
Thermo Fisher’s PPD Clinical Research Business Recognized as Industry Leader in Digital Services by ISG

The PPD clinical research business of Thermo Fisher Scientific, the world leader in serving science, has been honored for industry leadership in digital ...

August 15, 2024 | Thursday | News

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