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HEIDELBERG Holds Strong in FY 2024/25 Amid Market Challenges and Prepares for Growth in FY 2025/26

Submitted by fairsonline´s … on Tue, 05/27/2025 - 21:46

SHERIDAN, WYOMING – May 27, 2025 – Heidelberger Druckmaschinen AG (HEIDELBERG) has successfully navigated a challenging economic landscape, achieving its fiscal year 2024/25 targets while laying the groundwork for further growth in 2025/26. The company maintained a stable adjusted EBITDA margin of 7.1 percent and generated a clearly positive free cash flow of around €50 million, despite rising wage costs, a slightly lower sales volume, and expenses related to the drupa trade fair.

Seaway Printing Accelerates Automation with Landmark HEIDELBERG Investment

Submitted by fairsonline´s … on Tue, 05/27/2025 - 21:39

SHERIDAN, WYOMING – May 27, 2025 – Seaway Printing has taken a bold step toward fully autonomous production, becoming the first U.S. customer to implement HEIDELBERG’s Plate to Unit system, and integrating the world’s first Inline Splicer with the CutStar generation 4 sheeter. The move is part of a sweeping automation strategy aimed at significantly improving productivity and operational efficiency across Seaway’s expanded Wisconsin facility.

Seaway Printing Accelerates Automation with Landmark HEIDELBERG Investment

Submitted by fairsonline´s … on Tue, 05/27/2025 - 21:39

CHMP Recommends EU Approval of Roche’s Itovebi for Advanced Breast Cancer Treatment

Submitted by fairsonline´s … on Tue, 05/27/2025 - 21:14

SHERIDAN, WYOMING – May 27, 2025 – Roche has received a significant endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant. This recommendation positions Roche to offer a first-line treatment solution for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited current treatment options.

Roche and Broad Clinical Labs Join Forces to Advance Next-Gen Sequencing in Neonatal Care

Submitted by fairsonline´s … on Tue, 05/27/2025 - 21:07

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced a new strategic collaboration with Broad Clinical Labs, aiming to accelerate the adoption of its next-generation Sequencing by Expansion (SBX) technology, with an initial focus on trio-based whole genome sequencing for critically ill newborns and their biological parents. The partnership signifies a pivotal move in expanding genomics-enabled healthcare and precision medicine at scale.

Columvi Shows Sustained Survival Gains in Aggressive Lymphoma, Validating Roche’s Strategic Oncology Pipeline

Submitted by fairsonline´s … on Tue, 05/27/2025 - 20:51

SHERIDAN, WYOMING – May 27, 2025 – Roche has unveiled compelling two-year follow-up data from its pivotal phase III STARGLO trial, reinforcing the long-term clinical value of Columvi® (glofitamab) in combination with chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The results underscore the strategic impact of Roche’s bispecific antibody pipeline in addressing aggressive hematologic malignancies with limited treatment options.

FDA Approves Roche’s Susvimo for Diabetic Retinopathy: A Game-Changer in Retinal Treatment

Submitted by fairsonline´s … on Tue, 05/27/2025 - 20:42

SHERIDAN, WYOMING – May 27, 2025 – Roche has received FDA approval for Susvimo® (ranibizumab injection) 100 mg/mL as a new treatment for diabetic retinopathy (DR), marking a pivotal advancement in the battle against this vision-threatening condition that affects nearly 10 million Americans.

Columvi Combination Shows Promising Survival Benefit in Aggressive Lymphoma as FDA Review Progresses

Submitted by fairsonline´s … on Tue, 05/27/2025 - 20:33

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced an encouraging update on its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx), following discussion by the FDA’s Oncologic Drugs Advisory Committee (ODAC). The combination therapy demonstrated a significant 41% reduction in the risk of death in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for autologous stem cell transplant.

FDA Approves Roche’s VENTANA MET (SP44) RxDx Assay as First Companion Diagnostic for Emrelis Treatment in NSCLC

Submitted by fairsonline´s … on Tue, 05/27/2025 - 20:27

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced FDA approval of its VENTANA® MET (SP44) RxDx Assay, marking a major milestone in companion diagnostics for non-small cell lung cancer (NSCLC). This approval paves the way for a more precise identification of patients eligible for AbbVie’s Emrelis™ (telisotuzumab vedotin-tllv), a targeted therapy for non-squamous NSCLC with MET protein overexpression.

Enhancing Treatment Precision in Lung Cancer Care

Roche’s Perjeta-Based Regimen Shows 17% Reduction in Mortality in HER2-Positive Early Breast Cancer After 10 Years

Submitted by fairsonline´s … on Tue, 05/27/2025 - 20:20

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced compelling final results from the decade-long APHINITY Phase III clinical trial, demonstrating a significant 17% reduction in the risk of death for patients with HER2-positive early-stage breast cancer who received a Perjeta® (pertuzumab)-based adjuvant therapy. These findings reinforce the strategic role of the Perjeta-based regimen in long-term disease management and will be presented as a late-breaking abstract at the 2025 ESMO Breast Cancer Congress.

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