Tag Archives: Roche

Roche Showcases Advancements in Alzheimer’s Diagnostics at CTAD 2024

(IN BRIEF) At the CTAD 2024 congress in Madrid, Roche presented new data on its Elecsys® Amyloid Plasma Panel and Elecsys ptau181, demonstrating their effectiveness in diagnosing Alzheimer’s disease. The blood-based test showed a negative predictive value of 96.2% in … Read the full press release

University of Liverpool and Roche Diagnostics Unite to Drive Health Innovation and Address Inequalities

(IN BRIEF) The University of Liverpool has signed a Memorandum of Understanding (MoU) with Roche Diagnostics UK and Ireland to enhance research and innovation focused on improving health outcomes and addressing health inequalities. This partnership aims to align with Roche’s … Read the full press release

Roche’s Evrysdi Shows Remarkable Motor and Cognitive Outcomes in Children with SMA After Two Years of Early Treatment

(IN BRIEF) Roche has announced positive two-year data from its RAINBOWFISH study, showcasing the effectiveness of Evrysdi® (risdiplam) in treating children with spinal muscular atrophy (SMA) when administered before symptoms appear. The study revealed that most children achieved key motor … Read the full press release

Roche Secures CE Certification for Groundbreaking Companion Diagnostic Aiding Gastric Cancer Treatment

(IN BRIEF) Roche has announced the CE certification of its VENTANA CLDN18 (43-14A) RxDx Assay, marking a significant advancement in companion diagnostics for patients with gastric and gastroesophageal junction (GEJ) adenocarcinoma. This diagnostic tool enables clinicians to identify patients who … Read the full press release

Roche’s Gazyva Shows Breakthrough Results in Treating Lupus Nephritis, Offering Hope for Kidney Disease Patients

(IN BRIEF) Roche has announced positive results from its phase III REGENCY study, showing that its drug Gazyva®/Gazyvaro® (obinutuzumab) significantly outperformed standard therapy in treating active lupus nephritis. The study found that patients receiving Gazyva/Gazyvaro, in combination with standard therapies, … Read the full press release

Roche’s PiaSky Approved in EU as First Monthly Self-Administered Treatment for PNH

(IN BRIEF) Roche has received approval from the European Commission for PiaSky® (crovalimab), a novel treatment for paroxysmal nocturnal haemoglobinuria (PNH), making it the first monthly subcutaneous (SC) treatment available in the European Union. PiaSky, which can be self-administered by … Read the full press release

Roche Completes Acquisition of LumiraDx’s Point of Care Technology, Enhancing Global Diagnostic Capabilities

(IN BRIEF) Roche has completed the acquisition of LumiraDx’s Point of Care technology after receiving all necessary antitrust and regulatory clearances. This addition enhances Roche’s diagnostics portfolio with an advanced multi-assay platform that consolidates a wide range of tests, including … Read the full press release

Roche Launches Advanced Diagnostic Test for B-Cell Lymphoma Detection

(IN BRIEF) Roche has introduced the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first clinically approved in-situ hybridisation (ISH) test of its kind. Designed to enhance sensitivity in diagnosing B-cell lymphoma, the assay helps differentiate cancerous … Read the full press release

Roche Announces Retirement of Head of Pharma Partnering and Successor Appointment

(IN BRIEF) Roche (SIX: RO, ROG; OTCQX: RHHBY) reveals the retirement of James Sabry, the Head of Roche Pharma Partnering, after fourteen years of service. Effective 1 July 2024, Boris Zaïtra, currently Head of Group Business Development, will take on … Read the full press release

Roche and Amgen Collaborate on Breakthrough Lp(a) Test for Cardiovascular Disease Risk

(IN BRIEF) Roche Diagnostics has announced that its Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Developed in collaboration with Amgen, this innovative test aims to identify individuals at risk … Read the full press release

Roche’s Xolair Nears FDA Approval for Reducing Allergic Reactions to Multiple Foods

(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by … Read the full press release

Roche Achieves Top Sustainability Rankings in Pharmaceuticals Index for 15th Consecutive Year

(IN BRIEF) Roche (SIX: RO, ROG; OTCQX: RHHBY) has once again secured its position as one of the leading sustainable companies in the Pharmaceuticals sector within the Dow Jones Sustainability Indices (DJSI). In the latest rankings, Roche secured the third … Read the full press release

Roche Presents Promising Data on Innovative Lymphoma Treatments at ASH Annual Meeting

(IN BRIEF) Roche, a global pharmaceutical company, has shared compelling data from its CD20xCD3 T-cell engaging bispecific antibody program during the 65th American Society of Hematology (ASH) Annual Meeting & Exposition held in December 2023. The data includes extended follow-up … Read the full press release

Roche’s Kadcyla Demonstrates Long-Term Survival Benefit in HER2-Positive Early Breast Cancer

(IN BRIEF) Roche has released positive long-term follow-up data from the Phase III KATHERINE study, evaluating Kadcyla® (trastuzumab emtansine) as adjuvant therapy for people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant treatment. The study … Read the full press release

Roche Reports Positive Phase III Results for Inavolisib Combination Therapy in PIK3CA-Mutated Breast Cancer

(IN BRIEF) Roche has announced promising results from the Phase III INAVO120 study, which evaluated inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line treatment for individuals with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced, or metastatic … Read the full press release

Roche to Acquire Carmot Therapeutics for USD 2.7 Billion, Expanding Its Portfolio in Obesity Treatment

(IN BRIEF) Roche, a leading pharmaceutical company, has announced its definitive merger agreement to acquire Carmot Therapeutics, a privately owned US-based company specializing in obesity treatment and related metabolic diseases. The acquisition includes Carmot’s portfolio of clinical stage subcutaneous and … Read the full press release

Roche Introduces Elecsys® HBeAg Quant Test for Accurate Hepatitis B Diagnosis and Monitoring

(IN BRIEF) Roche has unveiled Elecsys® HBeAg quant, a new immunoassay designed to detect the presence and quantity of the hepatitis B e antigen (HBeAg) in human serum and plasma. This diagnostic tool simplifies the process for both clinicians and … Read the full press release

Roche Launches HEV Infection Detection Tests to Support Global Disease Management

(IN BRIEF) Roche has introduced the Elecsys®Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections in regions accepting the CE mark. These tests aim to assist clinicians in diagnosing the cause of patients’ symptoms, determining … Read the full press release

Roche’s Elecsys NfL Test for Multiple Sclerosis Earns Breakthrough Device Designation from FDA

(IN BRIEF) Roche, a leading healthcare company, has announced that its Elecsys Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The Elecsys NfL test is designed … Read the full press release

Roche’s OCREVUS Subcutaneous Injection Shows Promise in Phase III Study for Multiple Sclerosis Treatment

(IN BRIEF) Roche has announced positive late-breaking data from the Phase III OCARINA II study, which demonstrates the effectiveness of OCREVUS as a twice-yearly, 10-minute subcutaneous injection for patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS). The … Read the full press release