News and Press Releases
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
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
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
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Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2025
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Exclusive UniSafe® distribution agreement between Owen Mumford and NIPRO exceeds expectations in Japan with new biosimilar launch
6 December 2024 - Oxford, UK – Owen Mumford, a global leader in medical devices, is pleased to announce that its exclusive agreement with Osaka-based NIPRO CORPORATION (NIPRO) to distribute...
Category: Drug Delivery, Manufacturing and Packing
Posted: December 6, 2024
Duke Street Bio Granted Approval by European Medicines Agency to Launch Next-Generation PARP1-Selective Inhibitor Trial
24 September 2024 -- London, UK -- Duke Street Bio Ltd, a precision medicine biotech developing next generation small molecule cancer therapies, is pleased to announce that the European Medicines...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 24, 2024
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
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DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
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Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis
22 July 2024 -- Melbourne, Australia -- Certa Therapeutics, a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the European Medicines Agency...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: July 22, 2024
Just – Evotec Biologics expands tech partnership for biosimilars with Sandoz
Just – Evotec Biologics expands partnership with Sandoz for development and commercial manufacturing of biosimilars Additional biosimilars potentially to be added to Sandoz development pipeline Further guarantees for Sandoz long-term...
Category: BioManufacturing, Biotechnology
Posted: July 10, 2024
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Formycon receives FDA approval for FYB203/ AHZANTIVE) (aflibercept-mrbb), a biosimilar to Eylea
1 July 2024, Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, “Formycon”) and its licencing partnerKlinge Biopharma GmbH ("Klinge") jointly announce that the U.S. Food and Drug Administration ("FDA")approved FYB203/AHZANTIVE (aflibercept-mrbb),...
Category: Pharmaceutical
Posted: July 1, 2024
CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers The CHMP’s recommendation is based on results...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 28, 2024
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Formycon reports on the results of the annual general meeting
Management provides detailed report on financial year 2023 and current company performance. Shareholders approve all agenda items and formally approve the acts of the members of the management board and...
Category: BioManufacturing
Posted: June 13, 2024
Kite Receives European Medicines Agency Approval of Safety Monitoring Variation for CAR T-Cell Therapy Portfolio
In-hospital patient monitoring for adverse events reduced from ten to seven days following CAR T-cell therapy infusion 6 June 2024 -- Stockley Park, UK -- Kite, a Gilead Company, today...
Category: Biotechnology, Other, Pharmaceutical
Posted: June 6, 2024
