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.

Basel, 18 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo® (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.4

Roche's Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline one-year results from the open-label, single-arm Phase IV ELEVATUM study evaluating Vabysmo® (faricimab-svoa) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials. Initial data from 124 participants in the United States showed that after one year of treatment wit.

Genentech's Vabysmo Improved Vision in Underrepresented Populations With Diabetic Macular Edema (DME) in a First-Of-Its-Kind Study

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy.

Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

RHHBY obtains FDA approval for Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

Roche Wins FDA Nod for Breast Cancer Drug in First-Line Setting

Basel, 14 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented positive two-year data from the ongoing RAINBOWFISH study at the 29th World Muscle Society (WMS) Congress, 8-12 October, 2024, assessing the efficacy and safety of Evrysdi® (risdiplam) in children with SMA who were treated pre-symptomatically as infants before six weeks of age (n=23). The study found the majority of children achieved key motor milestones, were able to swallow and feed orally, and demonstrated cognitive skills typical of children without SMA, with none requiring permanent ventilation.

Majority of children with spinal muscular atrophy (SMA) treated with Roche's Evrysdi are able to sit, stand and walk independently, two-year data demonstrate

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented positive 2-year data from the ongoing RAINBOWFISH study at the 29th World Muscle Society (WMS) Congress, October 8-12, 2024, assessing the efficacy and safety of Evrysdi® (risdiplam) in children with SMA who were treated pre-symptomatically as infants before 6 weeks of age (n=23). The study found the majority of children achieved key motor milestones, were able to swallow.

Majority of Children With Spinal Muscular Atrophy (SMA) Treated With Genentech's Evrysdi Are Able to Sit, Stand and Walk Independently, Two-Year Data Demonstrate

Basel, 11 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.2

FDA approves Roche's Itovebi, a targeted treatment 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) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA.

FDA Approves Genentech's Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

Basel, 10 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANA Ⓡ CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas' targeted therapy VYLOY TM (zolbetuximab).

Roche obtains CE certification for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

Roche's CEO said on Wednesday that the Swiss drugmaker's oral drug candidate for breast cancer giredestrant could enter a market worth at least 10 billion Swiss francs ($11.66 billion) annually if it succeeds in two key trials on early treatment of the disease.

Roche CEO: breast cancer pill could be in 10 bln CHF market if trials succeed

Survey findings from over 8,700 people in 12 countries show that half of those polled have inadequate understanding of HPV, with nearly one-third being unsure or unaware of it altogether.1 Findings also show that significant barriers continue to exist that are preventing women from seeking screening.1 However, more than 70% of the respondents indicated they would be interested in the option of collecting their own sample for screening if available. TUCSON, Ariz.

Survey commissioned by Roche shows that HPV infection, which causes 99% of all cervical cancer cases, remains largely misunderstood by the general public

RHHBY has strengthened its pipeline with an agreement to acquire Regor's portfolio of next-generation CDK inhibitors for the treatment of breast cancer.

Roche Ramps Up Breast Cancer Pipeline With Regor's CDK Inhibitors

Roche said on Monday that three early-stage obesity and diabetes drug candidates from its acquisition of Carmot Therapeutics have the combined potential of more than 3 billion Swiss francs ($3.6 billion) in annual sales.

Roche targets more than $3 billion in annual obesity sales

RHHBY announces meeting primary and key secondary goals in the late-stage study of its lymphoma drug, Gazyva/Gazyvaro, for treating active lupus nephritis.

Roche's Lupus Study for Gazyva Meets Primary & Key Secondary Goals

Positive phase III results for Roche's Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline results from the Phase III REGENCY study of Gazyva® (obinutuzumab) in people with active lupus nephritis. In the study, a higher proportion of people treated with Gazyva plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) at 76 weeks compared to those treated with standard therapy alone. Safety.

Positive Phase III Results for Genentech's Gazyva Show Superiority to Standard Therapy Alone in People With Lupus Nephritis

Shares of Roche Holding AG pulled back this month after disappointing tolerability data was presented for CT-388 and CT-996 at the EASD conference. Roche sought the ceiling of safety and tolerability by aggressively increasing the doses of both candidates in these phase 1 trials. Future trials will have “start low and go slow” titration schemes which should improve tolerability of CT-388 and CT-996.

Roche: The Devil Is In The Details - Obesity Data Presentation Disappoints

Basel, 24 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the cobas® Respiratory flex test, the first to use Roche's novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology, developed by Roche scientists, uses multiplex polymerase chain reaction (PCR) testing, combined with colour, temperature and data processing, to identify as many as 15 pathogens in a single PCR test. Typically, PCR tests on a high throughput analyser are able to identify four results in a single test - TAGS technology makes it possible to increase this number to fifteen. This will enable syndromic panel testing on the high throughput molecular diagnostic analysers cobas® 5800, 6800 and 8800, which is especially important when a common group of symptoms can be related to more than one pathogen.

Roche launches the first test to use its breakthrough TAGS technology for high throughput, simultaneous detection of 12 respiratory viruses

Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.

WHO endorses dual-stain cytology (CINtec PLUS) testing in its cervical cancer prevention guidelines, advancing patient care and underlining Roche's role in pioneering cervical cancer solutions

Results from a late-stage study on RHHBY's Xofluza show that the drug reduces the transmission of influenza from an infected person to household members.

Roche Antiviral Drug Reduces Transmission in Late-stage Study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline results of the Phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contra.

Positive Phase III Results Show Xofluza Significantly Reduces the Transmission of Influenza Viruses

Basel, 19 September - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results of the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. Xofluza was well tolerated with no new safety signals identified.

Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses

Roche presented early-stage data on its obesity injection and pill at EASD. Meanwhile, Oura enters into metabolic health market with acquisition of Veri.

Healthy Returns: How competitive can Roche be in the weight loss drug market?

HAMBURG, Germany--(BUSINESS WIRE)--Mindpeak announces its collaboration with Roche that will integrate Mindpeak's innovative AI algorithm with Roche's Digital Pathology Open Environment, playing a crucial role in helping clinicans improve patient care and expanding personalized medicine. In a healthcare landscape where millions of diagnostic tests are performed daily, laboratories have become some of the largest data providers. The rising data volume, combined with the need to perform more test.

Mindpeak Announces Collaboration With Roche to Enhance Cancer Diagnostics Through AI

Basel, 16 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS ZUNOVO is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.

FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis

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