Roche (RHHBY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended a label expansion of ophthalmology drug Vabysmo (faricimab). The CHMP gave a positive opinion for the label extension of Vabysmo for a third indication — treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). Data from these studies showed Vabysmo demonstrated early and sustained vision improvements non-inferior to Regeneron's (REGN) Eylea ...

"People living with PNH face lifelong treatment, often requiring frequent intravenous infusions and timeconsuming clinic visits," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "With the option to self-administer once a month, today's recommendation may therefore offer patients and caregivers in Europe more freedom in their day-to-day lives." PiaSky is being investigated in a broad clinical development programme, including five ongoing Phase III studie ...

The WHO is focused on the elimination of cervical cancer globally with a strategy of three key goals.2 It seeks to ensure that by 2030, 70% of women are screened using a high-performance test by age 35, and again by age 45. Screening for HPV can help identify women who are at risk of developing cervical cancer, so that the disease can be treated early, before cancer has a chance to develop. In poorer countries, women are often diagnosed with cervical cancer at a more advanced stage, where the chance for a c ...

Provides an additional treatment option without the need for IV facilities, expanding accessibility for patients SAN DIEGO, June 25, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received European Commission (EC) marketing authorization of OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multipl ...

"OCREVUS transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved in this disease. Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "This makes it easier for more people with multiple sclerosis to access their treatment, while also saving time for providers." OCREVUS SC was ...

dpa/picture alliance via Getty Images Notably, RHHBY stock has underperformed the broader market in each of the last three years. Returns for the stock were 18% in 2021, -24% in 2022, and -7% in 2023. In comparison, returns for the S&P 500 have been 27% in 2021, -19% in 2022, and 24% in 2023 — indicating that RHHBY underperformed the S&P in 2021, 2022, and 2023. In fact, consistently beating the S&P 500 — in good times and bad — has been difficult over recent years for individual stocks; for heavyweights in ...

The cobas® c 703 and cobas® ISE neo analytical units, deliver higher testing capacity and increased automation helping to improve laboratory workflows and advance patient care. The new cobas c 703 analytical unit offers industry-leading high throughput clinical chemistry testing1 with up to 2,000 tests per hour and 70 reagent positions, doubling the existing clinical chemistry throughput on cobas pro integrated solutions. The new cobas ISE neo analytical unit delivers more efficient ISE testing, reducing ha ...

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, providing diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is the tenth most common cancer worldwide. ...

Ascidian's exon editing technology is designed to provide the durability of gene therapy by rewriting RNA, while sharply reducing the risks associated with direct DNA editing and gene replacement. This approach has the potential to treat patients with one dose of an RNA exon editor. Roche's shares have lost 3.4% year to date against the industry's growth of 20.4%. The acquisition gave Roche access to Carmot's differentiated portfolio of incretins, including CT-388, the lead asset, phase-II ready, dual GLP-1 ...

Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited. TUCSON, Ariz., June 18, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its whole-slide imaging system, the Roche Digital Pathology Dx (VENTANA DP 200), has received 510(k) clearance from the United States Food and Drug Administration (FDA). The system is intended to aid the pathologist in reviewin ...