News and Press Releases

Johnson & Johnson receives CHMP positive opinion for AKEEGA (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations

AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026

Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

ALK receives positive CHMP opinion for EURneffy 1mg (nasal adrenaline spray) for emergency anaphylaxis treatment in children (≥15kg)

30 January 2026 -- Hørsholm – Denmark -- Today ALK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026

Bøge Allé 6-8 DK-2970 Hørsholm Denmark

Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World

30 January 2026 -- Incheon, Korea -- Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of SB15, a biosimilar to...

Category: Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2026

76, Songdogyoyuk-ro, Yeonsu-gu, Incheon

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 15, 2026

76, Songdogyoyuk-ro, Yeonsu-gu, Incheon

Samsung Bioepis Begins Commercialization of BYOOVIZ, Biosimilar to Lucentis (Ranibizumab), in Europe

Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ BYOOVIZ becomes the fourth biosimilar directly commercialized by Samsung Bioepis in Europe, following EPYSQLI...

Category: Logistics, Other, Pharmaceutical
Posted: January 2, 2026

76, Songdogyoyuk-ro, Yeonsu-gu, Incheon

Horus Pharma announces strategic Agreement to commercialize Formycon’s Aflibercept Biosimilar FYB203 under the brand name Baiama across Key European Markets including its Home Market France

23 October 2025 -- Nice, France -- Horus Pharma, the second largest independent ophthalmological laboratory in France and a leading player in Europe, today announced that it has entered into...

Category: Logistics, Other, Pharmaceutical
Posted: October 23, 2025

22 allée Camille MUFFAT - Inedi 5 06200 Nice

SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting

20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025

Baldiri Reixac, 4 (08028) Barcelona, Spain

IAVI, Minapharm, and ProBioGen Announce Memorandum of Understanding to Progress Clinical Development, Manufacturing, Commercialization, and Access to Vaccines and Antibodies in Africa

Partners will advance end-to-end development of biologics for regionally prioritized diseases starting with Mpox and HIV 10 October 2025 -- Cairo, Egypt; Berlin, Germany; and New York, New York -- IAVI,...

Category: Biotechnology, Drug Delivery, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 10, 2025

Herbert-Bayer-Straße 8 13086 Berlin

Hikma and Celltrion strengthen partnership to expand biosimilar access in MENA

6 October 2025 -- London, UK -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, and its long-standing partner Celltrion Inc., a global biopharmaceutical leader, have signed exclusive licensing agreements...

Category: Logistics, Other, Pharmaceutical
Posted: October 6, 2025

1 New Burlington Place, London, W1S 2HR

European Marketing Application for AVT23, a Proposed Biosimilar to Xolair (omalizumab), Accepted by the European Medicines Agency

6 October 2025 -- London, UK and Reykjavik, Iceland -- Advanz Pharma Holdco Limited, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: October 6, 2025

Capital House, 1st Floor, 85 King William Street, London EC4N 7BL

Formycon secures U.S. License Date for proposed Aflibercept Biosimilar FYB203 following settlement and license agreement with Regeneron

Formycon and its partners entered into a settlement and license agreement with Regeneron for FYB203/AHZANTIVE (Aflibercept-mrbb) Pending litigation at the U.S. District Court for the Northern District of West Virginia...

Category: Logistics, Other, Pharmaceutical
Posted: October 2, 2025

Biocon Biologics Secures U.S. Market Entry Date for Bosaya and Aukelso, Denosumab Biosimilars

1 October 2025 -- Bengaluru, India and New Jersey, US -- Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, today announced a settlement and...

Category: Logistics, Other, Pharmaceutical
Posted: October 1, 2025

Biocon House, Semicon Park Electronics City, Phase – II, Hosur Road Bengaluru 560100, Karnataka, India

Novo Nordisk A/S: Ozempic receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities

Pending a decision from the European Commission, Ozempic (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar,...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 23, 2025

Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd Denmark

Celltrion opens new UK headquarters in Uxbridge, UK

New office located in the heart of Uxbridge underscores Celltrion’s long-term business commitment in the UK 17 June 2025 -- London, UK -- Celltrion UK has officially opened its new...

Category: Clinical Trials, Drug Discovery, Manufacturing and Packing, Other, Pharmaceutical
Posted: June 17, 2025

23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea

Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer

Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of...

Category: Drug Discovery, Other, Pharmaceutical
Posted: May 6, 2025

Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG