Moderna's Updated COVID-19 Vaccine Receives Positive Opinion from EMA, Targeting Omicron Variant JN.1

Moderna, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion r...

September 06, 2024 | Friday | 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
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
Biocon Biologics Secures Global Market Access for Bmab 1200 with Janssen Settlement Agreement

  Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd , announced that the Company has sign...

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
Moderna Secures European Commission Approval for First mRNA RSV Vaccine, mRESVIA®

Moderna, Inc. announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial...

August 26, 2024 | Monday | News
Pharma Nordic AS Expands Bentrio® Distribution to Sweden and Denmark Following Successful Norway Launch

Successful launch of Bentrio by Pharma Nordic AS in Norway in 2024 Exclusive distribution agreement extended to also include Sweden and Denmark Alt...

August 23, 2024 | Friday | News
Brains Bioceutical on Track to Achieve One of the World’s First CEP Certifications for Cannabidiol with EDQM Approval

Brains Bioceutical Set to Achieve One of the World’s First CEP for Cannabidiol Certification with the European Directorate for the Quality of Medic...

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
Alcura Receives MIA License for Cell and Gene Therapies, Expanding CGT Support Across Europe

Alcura, a provider of specialized clinical trial services and a part of Cencora, has been granted a Manufacturing and Importation Authorization (MIA) lic...

August 15, 2024 | Thursday | News
Renexxion and Dr. Falk Pharma Begin U.S. Patient Dosing in Global Phase 2b Study for Promising Gastroparesis Treatment

Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high u...

August 14, 2024 | Wednesday | News
BioSenic Secures Key Japanese Patent for Enhanced Arsenic-Based Therapeutics in Autoimmune and Cancer Treatments

Composition-of-matter patent covers the therapeutic use of arsenic salts and metal ions through various routes of administration. Enriched IP portfoli...

August 14, 2024 | Wednesday | News
Stereotaxis Announces CE Mark Approval and FDA Submission for Revolutionary GenesisX Robotic System

Stereotaxis, a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE mark in Eu...

August 13, 2024 | Tuesday | News

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