MSD and EyeBio Announce Initiation of Phase 2b/3 BRUNELLO Trial for Restoret™ (MK-3000) in the Treatment of Diabetic Macular Edema

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., US...

September 05, 2024 | Thursday | News
European Medicines Agency Grants Orphan Drug Designation to SeaBeLife's SBL01 for Acute Liver Failure

Orphan designation shows recognition of therapeutic potential of drug candidate SBL01 targeting two regulated cell death pathways European Medicines A...

September 04, 2024 | Wednesday | News
Valneva and Pfizer Report Positive Phase 2 Results for Lyme Disease Vaccine Candidate, VLA15, Following Second Booster Dose

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) today announced positive results from the VLA15-221 Phase 2 study of t...

September 03, 2024 | Tuesday | News
Nxera Pharma to Receive $35 Million Milestone Payment from Neurocrine Following Successful Phase 2 Schizophrenia Trial

Nxera Pharma Co – formerly known as Sosei Group or Sosei Heptares – announces that it will receive a US$35 million payment from Neurocrine Bi...

September 03, 2024 | Tuesday | News
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

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