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News and Press Releases

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

Just – Evotec Biologics
info@evotec.com
Just – Evotec Biologics, Inc. 401 Terry Avenue North Seattle, WA 98109, US

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

Formycon
inof@formycon.com
Formycon AG, Fraunhoferstraße 15, 82152 Martinsried/Planegg, Germany

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

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

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

Formycon
inof@formycon.com
Formycon AG, Fraunhoferstraße 15, 82152 Martinsried/Planegg, Germany

Johnson & Johnson receives positive CHMP opinion for RYBREVANT▼ (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations

This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is...

Category: Clinical Trials, Pharmaceutical
Posted: April 29, 2024

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

Janssen Receives Positive CHMP Opinion for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma

Results from the phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment Most...

Category: Clinical Trials
Posted: February 23, 2024

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

Biocon Biologics Successfully Completes Integration of Viatris’ Biosimilar Business in 31 Countries in Europe

30 November 2023 -- Bengaluru, India -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, today announced that the integration of the Viatris’ biosimilars business in 31 European countries has been successfully...

Category: Pharmaceutical
Posted: November 30, 2023

Biocon Biologics
contact@bioconbiologics.com
Biocon House, Semicon Park Electronics City, Phase – II, Hosur Road Bengaluru 560100, Karnataka, India

European Commission Approves ADCETRIS (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD  

· Approval Based on Updated Positive Overall Survival Results from the phase 3 ECHELON-1 Study for Stage III & IV Hodgkin Lymphoma  · First Significant Improvement in Overall Survival in Two Decades...

Category: Pharmaceutical
Posted: October 23, 2023

Takeda Pharmaceutical Company
61 Aldwych, London, WC2B 4AE, UK

Mundipharma and Cidara Therapeutics receive positive CHMP opinion forrezafungin for the treatment of Invasive Candidiasis in adults

The opinion was based on positive results from the pivotal ReSTORE phase 3 clinicaltrial and supported by the STRIVE phase 2 clinical trials and extensive nonclinicaldevelopment programme If approved by...

Category: Biotechnology
Posted: October 17, 2023

Cidara Therapeutics
info@cidara.com
6310 Nancy Ridge Drive Suite 101 San Diego, CA 92121

pharmaand GmbH Receives Positive CHMP Opinion for Rubraca (rucaparib) as a First-Line Maintenance Treatment in Advanced Ovarian Cancer

CHMP positive opinion based on the results from Phase 3 ATHENA-MONO trial European Commission (EC) approval decision expected in the coming months This is the first rucaparibregulatory milestone since being...

Category: Pharmaceutical
Posted: October 17, 2023

pharmaand (pharma&)
contact@pharmaand.com
pharmaand GmbH Taborstraße 1 1020 Wien, Austria