Samsung Bioepis Reclaims European Commercial Rights for BYOOVIZ®, Expanding Direct Biosimilar Portfolio

Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ® BYOOVIZ becomes the fourth biosimi...

January 05, 2026 | Monday | News
Valneva Regains Full Rights to Single-Shot Chikungunya Vaccine, Ends Licensing Deal with Serum Institute of India

Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), a Cyrus Poonawalla Grou...

January 02, 2026 | Friday | News
Transcenta Therapeutics Enters Strategic Bioprocessing Collaboration With EirGenix

  Transcenta Holding Limited (HKEX: 06628) (“Transcenta Therapeutics”), a global clinical stage biopharmaceutical company with fully-inte...

December 31, 2025 | Wednesday | News
Zevra Therapeutics Signs Exclusive Expanded Access Distribution Deal With Uniphar for MIPLYFFA

Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare ...

December 31, 2025 | Wednesday | News
Mereo BioPharma’s Phase 3 Setrusumab Studies Miss Primary Fracture Endpoints in Osteogenesis Imperfecta

Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (ORBIT) or bisphosphonates (COSMIC) Bo...

December 31, 2025 | Wednesday | News
Nutriband Sells 90% of Pocono Pharmaceutical to EarthVision Bio for $5M

Earthvision Bio, is currently developing and commercializing its line of sustainable products developed by Dr. Gordon Moore, the founder of Intel, and Dr. ...

December 31, 2025 | Wednesday | News
Diamyd Medical Aligns with FDA to Accelerate Phase 3 DIAGNODE-3 Efficacy Readout in Type 1 Diabetes

Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, ...

December 30, 2025 | Tuesday | News
Hansa Biopharma Submits FDA BLA for Imlifidase in Highly Sensitized Kidney Transplant Patients

The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients Imlifida...

December 29, 2025 | Monday | News
Flagship Pioneering and Pfizer Launch New Repertoire-Led Program to Develop TCR Bispecifics for Metastatic Prostate Cancer

Flagship Pioneering, a scientific innovation engine for transformative platforms and products, announced a research program under its strategic collabora...

December 25, 2025 | Thursday | News
datma and Rhythm Biosciences Launch Exploratory Collaboration to Advance Genomic-Integrated Cancer Risk Prediction

The two companies will explore how datma's federated ecosystem can support Rhythm Biosciences' diagnostic development efforts as they shape a future comm...

December 25, 2025 | Thursday | News
SN Bioscience’s SNB-101 Secures FDA Orphan Drug Designation for Gastric Cancer

SN Bioscience Inc. (CEO Young Hwan PARK) announced that the FDA had granted Orphan Drug Designation (ODD) on December 10 for gastric cancer (including gast...

December 25, 2025 | Thursday | News
Alvotech Launches Europe’s First Biosimilar to Simponi® With Gobivaz® Rollout

Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, a...

December 24, 2025 | Wednesday | News
Symbiosis Manufactures First 10,000-Vial Batch at New Stirling Sterile Fill-Finish Facility

Symbiosis Pharmaceutical Services (Symbiosis), a leading sterile fill finish contract manufacturing organisation (CMO), has manufactured their first 10,0...

December 24, 2025 | Wednesday | News
Mondego Bio Selects Lead PTPN2 Inhibitor ZE00-0388, Enters Clinical Stage

Mondego Bio, a clinical-stage biotechnology company developing next-generation small-molecule immuno-oncology therapies, announced the formal selection o...

December 23, 2025 | Tuesday | News

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