Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Roche (RHHBY) gets exclusive, target-specific rights to Ascidian's RNA exon editing technology for undisclosed neurological targets for an initial payment of $42 million.

Roche (RHHBY), Ascidian Team Up for RNA Exon Editing Therapeutics

Biogen

Eli Lilly

The Alzheimer's treatment landscape presents a compelling opportunity for investors in healthcare and biotech. Alzheimer's disease is a progressive and debilitating neurodegenerative disorder that poses a significant and growing threat to global health and economic well-being.

Alzheimer's Drug Stocks: Investing in Eli Lilly, Biogen, Roche

Roche continues to face challenges tied to lackluster revenue and profit outlook, questionable pipeline, and an underperforming diagnostics business. Roche spends aggressively on its pipeline (R&D and M&A) and is more successful than peers in converting R&D to revenue by some metrics, but trailing growth rates are quite lackluster. If key pipeline candidates like tiragolumab, prasinezumab, and RG6631 come through, Roche could see revenue and earnings reacceleration.

More Of The Same Isn't Good Enough For Roche

Swiss drugmaker Roche will team up with privately held biotech Ascidian Therapeutics to develop gene therapies targeting difficult to treat neurological diseases, the Boston-based startup said on Tuesday.

Roche partners with Ascidian Therapeutics to develop gene therapies

The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. 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.

Roche receives FDA clearance on its digital pathology solution for diagnostic use

Roche's (RHHBY) Columvi significantly extends survival in patients with relapsed or refractory diffuse large B-cell lymphoma in the phase III STARGLO study.

Roche (RHHBY) Reports Upbeat Data on Columvi From STARGLO Study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today statistically significant and clinically meaningful results from its Phase III STARGLO study of Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) versus Rituxan® (rituximab) in combination with GemOx (R-GemOx) for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line.

Genentech's Phase III STARGLO Study Demonstrates Columvi Significantly Extends Survival in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Roche's (RHHBY) Alecensa gets the European Commission's approval as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer.

Roche (RHHBY) NSCLC Drug Alecensa Gets EC Nod for Label Expansion

Roche in a lawsuit accused manufacturers and sellers based in India of selling counterfeit versions of its Accu-Chek devices on Amazon. Roche said the test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche's registered U.S. trademarks and fake expiration dates.

Roche alleges counterfeit diabetes medical devices were sold on Amazon

Dublin, June 10, 2024 (GLOBE NEWSWIRE) -- The "Roche Diagnostics International Ltd - Product Pipeline Analysis, 2024 Update" company profile has been added to ResearchAndMarkets.com's offering. This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. Report Scope:

Roche Diagnostics Company Profile 2024, Featuring a Detailed Product Pipeline Analysis and Ongoing Clinical Trials Insights

Basel, 10 June 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas® liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV).

Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization

European Commission approves Roche's Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer

Basel, 07 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new five-year data confirming the sustained efficacy and safety profile of Evrysdi® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA) from the open-label extension of the pivotal FIREFISH study. By the end of Year 5, 91% of children treated with Evrysdi were alive, 81% were alive without permanent ventilation and the majority were able to sit without support for at least 30 seconds (59%). At the end of year 5, seven children were able to stand, three with support, four unaided and six could walk with support. Without disease modifying treatment, natural history studies indicate that children with Type 1 SMA would not only never be able to reach such milestones, but also not typically live past the age of two. The data were presented at the Cure SMA Research & Clinical Care Meeting, June 5 - 7, 2024.

Five-year data for Roche's Evrysdi show the majority of treated children with a severe form of spinal muscular atrophy (SMA) achieved or maintained the ability to sit, stand or walk

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new 5-year data confirming the sustained efficacy and safety profile of Evrysdi® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA) from the open-label extension of the pivotal FIREFISH study. By the end of year 5, 91% of children treated with Evrysdi were alive, 81% were alive without permanent ventilation and the majority were able to sit without su.

Five-year Data for Genentech's Evrysdi Show the Majority of Treated Children With a Severe Form of Spinal Muscular Atrophy (SMA) Achieved or Maintained the Ability to Sit, Stand or Walk

The FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag

Basel, 29 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

FDA grants Priority Review to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growt.

FDA Grants Priority Review to Genentech's Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

Renewed partnership combines best in class engineering capabilities with cutting edge science to accelerate the availability of new solutions for customers and patients worldwide Upcoming launches of the new cobas® c703 & ISE neo units and cobas® Mass Spec solution are testament to the partnership's dedication to continued innovation The new 10-year contract will focus on strengthening the partnership for continued transformative innovation for patients BASEL, Switzerland , May 27, 2024 /PRNewswire/ -- Roche announced today that Hitachi High-Tech and Roche have extended their partnership, committing to at least 10 years of additional collaboration. Bringing together the companies' expertise and track record in diagnostics innovation, engineering and manufacturing, the renewed contract further strengthens the two companies' long lasting partnership.

Roche and Hitachi High-Tech extend their 46-year partnership, paving the way for further breakthroughs in diagnostic testing

Basel, 27 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that James Sabry (1958), Head of Roche Pharma Partnering, will be retiring after fourteen years with the company.

Changes to the Roche Enlarged Corporate Executive Committee

Basel, 22 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue.

Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

Roche's (RHHBY) inavolisib gets Breakthrough Therapy Designation in the United States for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

Roche (RHHBY) Cancer Drug Gets Breakthrough Therapy Designation

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic.

FDA Grants Breakthrough Therapy Designation to Genentech's Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

Basel, 21 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

FDA grants Breakthrough Therapy Designation to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

The mean weight loss in a Phase 1b trial of the GLP/GIP against CT-388 (once-a-week injection for 24 weeks) has just read out at 18.8%, with (apparently) no safety signals. Amgen sort-of-announced positive results on its candidate, MariTide.

GLP-1 Drug Development Market Pile-Up Continues

Roche's obesity candidate CT-388 showed positive results in a phase 1b trial, with an 18.8% placebo-adjusted weight loss at week 24. The full data presentation is needed to assess safety and tolerability and how CT-388 stacks up against key competitors. Roche's emerging cardiometabolic pipeline could become one of the fastest growing segments in the next 10+ years.

News for Roche Holding AG Stock (RHHBY)