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Norgine Submits Marketing Authorisation Application to EMA for Eflornithine in High-Risk Neuroblastoma

Norgine announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk ne...

January 07, 2025 | News

Chime Biologics and Mabgeek Achieve Major Milestone with PPQ Completion for MG-K10 Antibody

Process Performance Qualification (PPQ) validates robust manufacturing standards and is crucial for regulatory compliance Marks a key step forward for t...

January 06, 2025 | News

European Commission Approves Amivantamab Plus Lazertinib for First-Line Treatment of EGFR-Mutated NSCLC

Janssen-Cilag International NV, a Johnson & Johnson company,announced the European Commission (EC) approval for a Type II variation indication extensio...

January 03, 2025 | News

Sensorion Completes Enrollment for First Cohort in Audiogene Phase 1/2 Gene Therapy Trial

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to re...

January 01, 2025 | News

India’s Akums Secures $200 Million Deal to Supply Oral Liquid Formulations for European Markets

Akums Drugs & Pharmaceuticals, a leading Indian contract development and manufacturing organization (CDMO), announced a landmark $200 million agreement...

December 27, 2024 | News

Achilles Therapeutics Transfers TRACERx and MAP Data to AstraZeneca in $12M Deal

Proprietary data and samples from TRACERx and Achilles’ Material Acquisition Platform (MAP) will be transferred to AstraZeneca under the Transa...

December 25, 2024 | News

Daiichi Sankyo and AstraZeneca Withdraw EU Application for Datopotamab Deruxtecan in NSCLC

Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DX...

December 25, 2024 | News

BioPharma Europe: The Exclusive News Portal for the European Biopharma Industry

The European biopharmaceutical industry now has a dedicated platform for accessing the latest insights, trends, and developments with the launch of BioPhar...

December 24, 2024 | News

Sanofi and SK Bioscience Forge Expanded Alliance to Combat Pneumococcal Disease with Next-Gen Vaccines

Pneumococcal disease remains a major global health challenge despite the availability of current vaccines This 21-valent pneumococcal conjugate vaccine ...

December 23, 2024 | News

Merck Accelerates Next-Generation Drug Discovery with Acquisition of HUB Organoids

HUB internationally recognized pioneer in organoid development Acquisition expands Merck’s 2D and 3D cell culture portfolio Organoids part of fas...

December 19, 2024 | News

Lonza Opens State-of-the-Art R&D Facility in Slough, UK to Drive Biologics Innovation

Lonza, a global leader in biotechnology and pharmaceutical manufacturing, is proud to announce the opening of its new state-of-the-art research and develop...

December 19, 2024 | News

Sanofi and Teva Report Positive Phase 2b Results for Duvakitug in Ulcerative Colitis and Crohn’s Disease

Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpo...

December 18, 2024 | News

Menarini Group Reports Positive Phase 3 Results for Obicetrapib in Reducing LDL-C Levels

– Both pivotal studies achieved primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapie...

December 17, 2024 | News

CHMP Endorses Celltrion’s Biosimilars Eydenzelt Stoboclo Osenvelt and Avtozma for Expanded Access to Biologic Treatments

The Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenz...

December 16, 2024 | News

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