Ardena Secures Full GMP Approval for Expanded Nanomedicine Facility in Oss, Netherlands

" Ardena, a leading CDMO, has received full GMP approval for its advanced nanomedicine facility in Oss. This €20 million investment, featuring state...

November 20, 2024 | Wednesday | News
AstraZeneca’s Tagrisso (osimertinib) Recommended for EU Approval in Unresectable EGFR-Mutated Lung Cancer

AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with ...

November 19, 2024 | Tuesday | News
European Commission Approves OPUVIZ™ (SB15), a Biosimilar to Eylea, for Treatment of Retinal Disorders

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution...

November 19, 2024 | Tuesday | News
Tirzepatide Significantly Reduces Heart Failure Risk in Obese Patients with Preserved Ejection Fraction, New Data Show

Eli Lilly and Company (NYSE: LLY) announced detailed results from the SUMMIT Phase 3 trial showing tirzepatide significantly reduced the risk of worsening ...

November 18, 2024 | Monday | News
EMA Committee Recommends Approval of Opdivo® + Yervoy® for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

 Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...

November 18, 2024 | Monday | News
EMA CHMP Issues Positive Opinion for Lecanemab in Early Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

November 15, 2024 | Friday | News
GSK’s Blenrep Combination Demonstrates Significant Survival Benefit in Relapsed/Refractory Multiple Myeloma

GSK plc (LSE/NYSE: GSK) announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Bl...

November 15, 2024 | Friday | News
EMA Committee Recommends Approval of Sarclisa in Combination with VRd for Transplant-Ineligible Multiple Myeloma

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval ...

November 15, 2024 | Friday | News
MSD Acquires Global License for LM-299, a Novel PD-1/VEGF Bispecific Antibody from LaNova Medicines

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and LaNova Medicines Ltd. (LaNova), a privately held clinical-stage biotechnology ...

November 15, 2024 | Friday | News
BioNTech Acquires Biotheus to Strengthen Oncology Pipeline with Bispecific Antibody Asset BNT327/PM8002

BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Biotheus (“Biotheus”) announced the signing of a definitive agreement for...

November 14, 2024 | Thursday | News
Gilead’s Lenacapavir Demonstrates Strong Efficacy and High Adherence in Phase 3 PURPOSE 2 Trial for HIV Prevention

Gilead Sciences, Inc. (Nasdaq: GILD) presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752), which is stu...

November 14, 2024 | Thursday | News
TAE Life Sciences and Stella Pharma Announce Exclusive Collaboration to Expand BNCT Therapy in the U.S. and Europe

TAE Life Sciences (TLS), a leader in boron neutron capture therapy (BNCT) technology, and Stella Pharma, the pioneering developer of the boronophenylalan...

November 14, 2024 | Thursday | News
NurExone Gains EMA Orphan Designation for ExoPTEN, Advancing Spinal Cord Injury Therapy Across Europe

NurExone Biologic Inc.  a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the European Medici...

November 14, 2024 | Thursday | News
GenScript Biotech Global Forum 2024: Paving the Way for Innovation and Investment in Cell and Gene Therapy

- The global cell and gene therapy (CGT) industry is poised for remarkable growth, driven by significant advances in life sciences and robust investments...

November 14, 2024 | Thursday | News

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