March 5, 2025 Acad, Gov/Utilities

FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit1 The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis1 Lupus nephritis affects 1.7 million people worldwide; up... Read more

February 12, 2025 Acad, Gov/Utilities

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy (SMA)

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration... Read more

February 4, 2025 Acad, Gov/Utilities

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) With as few as two treatments per year, Susvimo may help people with DME maintain their vision Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular... Read more

January 31, 2025 Acad, Gov/Utilities Bio/Pharma/CRO Clinical Research/Diagn. PAI Top-10 PR/Corporate

Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU

As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes. The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since... Read more

January 22, 2025 Acad, Gov/Utilities Liq. Handling & Robotics PR/Corporate

Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic.1 FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues. The tests use highly sensitive, gold-standard... Read more

January 14, 2025 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Life Science Tools

PacBio and Radboud UMC Announce Remarkable Study Results Using HiFi Long Read Sequencing to Help Advance Rare Disease Diagnostics

MENLO PARK, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) — PacBio (NASDAQ: PACB), a leading provider of highly accurate long-read sequencing solutions, announced a significant publication from Radboud University Medical Center (Radboudumc) and its research partners in the American Journal of Human Genetics. The study demonstrates the impact of PacBio’s HiFi long-read sequencing technology in identifying... Read more

December 5, 2024 Acad, Gov/Utilities PAI Top-10

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Application is based on data from the phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival1,2 This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression Improving... Read more

November 5, 2024 Acad, Gov/Utilities PAI Top-10 Product Launch

Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024

Basel, 05 November 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 in San Diego, US. The data underscore Roche’s commitment to advance patient outcomes in... Read more

September 4, 2024 Acad, Gov/Utilities Atomic Spectroscopy Clinical Research/Diagn.

Revio to Power Research in Male Infertility and Rare Disease at Münster University Hospital

MENLO PARK, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) — PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, today announced a collaboration with the University Hospital of Münster, to use long-read whole genome sequencing to significantly advance male infertility and rare disease research. By deploying PacBio’s Revio HiFi sequencing system, researchers at... Read more