Roche

(IN BRIEF) Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HER2-ultralow status in HR-positive, HER2-negative metastatic breast cancer patients. This new approval offers a potential treatment … Read the full press release →

(IN BRIEF) Roche has reported positive results from the second year of the EMBARK Phase III trial of Elevidys (delandistrogene moxeparvovec), the first approved gene therapy for Duchenne muscular dystrophy (DMD). The results showed statistically significant and clinically meaningful improvements … Read the full press release →

(IN BRIEF) Holcim has announced its next steps in preparing for the spin-off of its North American business, including the designation of the new Board of Directors. The 10-member Board will become official following shareholder and regulatory approvals, expected by … Read the full press release →

(IN BRIEF) Roche has announced results from the Phase IIb PADOVA study evaluating prasinezumab in 586 individuals with early-stage Parkinson’s disease. While the primary endpoint of time to confirmed motor progression narrowly missed statistical significance, promising efficacy trends were observed, … Read the full press release →

(IN BRIEF) Roche has received CE certification for its enhanced cobas® 6800/8800 systems 2.0, introducing significant improvements in laboratory diagnostics. The upgrade streamlines operations by reducing downtime, consolidating test menus, and increasing throughput, supported by innovative TAGS technology that detects … Read the full press release →

(IN BRIEF) Roche’s Vabysmo® (faricimab) prefilled syringe has received European Medicines Agency approval for treating three major retinal conditions: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema caused by retinal vein occlusion (RVO). Serving over nine … Read the full press release →

(IN BRIEF) Roche presented new data at the ASH 2024 meeting highlighting the effectiveness of its bispecific antibodies, Columvi and Lunsumio, in treating lymphomas. Long-term studies show durable remissions and immune system recovery with fixed-duration therapies, while real-world data emphasize … Read the full press release →

(IN BRIEF) Roche has announced the acquisition of Poseida Therapeutics, a clinical-stage biopharmaceutical company specializing in off-the-shelf CAR-T cell therapies, for $9.00 per share in cash, totaling approximately $1 billion. Poseida stockholders may also receive up to $4.00 per share … Read the full press release →

(IN BRIEF) Roche provided an update on its Phase III SKYSCRAPER-01 study, evaluating tiragolumab in combination with Tecentriq® for patients with PD-L1-high, advanced, or metastatic non-small cell lung cancer (NSCLC). The study did not meet its primary endpoint of improving … Read the full press release →

(IN BRIEF) ANDRITZ Perfojet celebrates its 40th anniversary as a leader in nonwoven technology, known for its groundbreaking Jetlace™ hydroentanglement systems that bond fibers without binders. With over 300 systems installed globally, the company has revolutionized the production of nonwovens … Read the full press release →

(IN BRIEF) Roche announced the publication of pivotal phase III results for its Itovebi™ (inavolisib)-based regimen at the Clinical Trials in Alzheimer’s Disease congress, demonstrating a 57% reduction in the risk of disease progression or death in patients with HR-positive, … Read the full press release →

(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 →