Abzena Expands Analytical Capabilities with GMP Cell-Based Potency Assays at Cambridge and San Diego Facilities

" Abzena, a leading CDMO/CRO, now offers GMP cell-based potency assays at its UK and US sites, enhancing its support for complex biologics and ADC programs...

November 20, 2024 | Wednesday | News
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
Eli Lilly Announces Positive Phase 2 Results for Muvalaplin, Oral Treatment for Elevated Lp(a) Levels and Heart Disease Risk

Eli Lilly and Company (NYSE: LLY) announced positive Phase 2 results for muvalaplin, an investigational once-daily, orally administered selective inhi...

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
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
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
TrakCel's OCELLOS Platform Chosen to Support Five Key Cell Therapy Products in 2024, Streamlining CGT Supply Chain Management

TrakCel, a provider of integrated cell and gene therapy (CGT) orchestration solutions for the precise management, control and tracking of CGTs has announce...

November 13, 2024 | Wednesday | News
Alexion and Merck Report Positive Phase 3 KOMET Trial Results for KOSELUGO in Treating Adult Patients with Neurofibromatosis Type 1

Alexion, AstraZeneca Rare Disease and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced positive topline results from the ...

November 13, 2024 | Wednesday | News

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