Amneal Pharmaceuticals

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Latest News From Roche

The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL Data were featured in the congress Press Briefing and presented today in the... Read More
After 5 years of treatment, 91% of children were alive — without treatment, children with Type 1 SMA would not be expected to live past 2 years of age 96% of Evrysdi-treated children could swallow, 80% could feed without a feeding tube and 59% could sit without support for at least 30 seconds Evrysdi is now approved in more than 100 countries with over 15,000 patients treated globally SOUTH SAN FRANCISCO, Calif. / Jun 07,... Read More
Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting The target action date for the FDA decision is November 27, 2024 SOUTH SAN FRANCISCO, Calif. / May 29, 2024 / Business Wire / Genentech, a member... Read More
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... Read More
The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment This is the 29th Breakthrough Therapy Designation for Genentech’s... Read More
Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (p < 0.001) At week 24, 100% of CT-388 treated participants achieved >5% weight loss, 70% achieved >15% and 45% achieved >20% weight loss In a subgroup with pre-diabetes at baseline, CT-388 treatment normalized glycemia in all patients, indicating its strong... Read More
More than half of all U.S. cervical cancer patients are underscreened 1 , which makes reducing barriers to sample collection and increasing access to screenings crucial to ultimately helping eliminate this deadly disease. Each year in the U.S., more than 13,000 patients are diagnosed with cervical cancer and approximately 4,000 die from this preventable disease, caused by HPV infection. 1 Roche’s human papillomavirus (HPV)... Read More
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC) This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy The National Comprehensive... Read More
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations U.S. FDA and EMA accepted filings based on... Read More
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma Data from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting SOUTH SAN FRANCISCO, Calif. / Apr 15, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),... Read More
The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company Once approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer’s disease Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis Basel, 11 April 2024 - Roche (SIX: RO,... Read More
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2. 1 Patients with HER2-low status may now be eligible for HER2-targeted treatment, which could significantly improve their outcome. 2 The VENTANA HER2 (4B5) test is the only approved companion diagnostic indicated as an aid in the assessment of HER2-low status in metastatic breast cancer patients. TUCSON, Ariz. , April 10, 2024... Read More
The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria Malaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusion Roche is dedicated to saving patients’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseases Basel, 26 March... Read More
Roche introduces its suite of navify operational excellence solutions, including navify Analytics and navify Monitoring, for use in laboratories and point of care services navify Analytics provides operational insights to lab managers and point of care coordinators to manage workflows more efficiently, reduce costs, and improve productivity Insights from navify Analytics, combined with the real-time insights from navify... Read More
Detailed results from the NIH-sponsored Phase III OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as 1 year consumed without an allergic reaction The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies Allergic reactions can be life-threatening and it is estimated that... Read More
Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once... Read More
PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop artificial intelligence (AI) digital pathology algorithms for RTD's companion diagnostics business. The image analysis algorithms will be deployed on Roche's navify Digital Pathology platform, allowing seamless integration into pathology laboratories worldwide. The collaboration between RTD and PathAI helps advance precision medicine by bringing... Read More
Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry vision Up to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apart Detailed results from two global Phase III RVO studies will be presented at Angiogenesis, Exudation, and Degeneration 2024 Vabysmo is approved in the U.S. for RVO, and in more than 90 countries around the world for people... Read More
Remix to leverage REMaster ™ platform to discover novel drugs for a diverse range of target classes Remix will receive $30 million upfront and is eligible to receive up to $12 million in near-term milestone payments and up to $1 billion in milestone payments and royalties WATERTOWN, Mass. , Jan. 3, 2024 /PRNewswire/ -- Remix Therapeutics (Remix), a clinical stage biotechnology company developing small molecule therapies to... Read More
The transformative point of care solution will complement Roche’s centralised diagnostics portfolio across Clinical Chemistry, Immunochemistry, Coagulation and Molecular, and across multiple disease areas LumiraDx’s technology integrates multiple Point of Care tests on a simple to use single instrument and brings more affordable and accessible testing to patients worldwide Under the terms of the agreement, R oche will pay a... Read More
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure Interim analysis results from first-of-its-kind Phase III OUtMATCH study showed Xolair significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction 17 million people in the U.S. have confirmed food allergies and more than 40% of children and more than half... Read More
Healthcare professionals greatly value navify Tumor Board for improving tumour board meeting experiences, offering a holistic view of data, facilitating multidisciplinary team collaboration and optimising care decisions navify POC Operations attains excellent ratings from health professionals for enhancing point-of-care device management to improve patient care navify Lab Operations' ability to consolidate and automate lab... Read More
Longer-term data from pivotal studies of fixed-duration Columvi and Lunsumio continue to show durable responses in people with heavily pre-treated lymphomas New data reinforce the potential of combination regimens in earlier treatment settings and add to the robust body of evidence supporting ongoing Phase III studies SOUTH SAN FRANCISCO, Calif. / Dec 10, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX:... Read More
Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favorable efficacy and safety profile of subcutaneous Hemlibra given soon after birth At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma Safety results were consistent with previous studies of Hemlibra,... Read More
Phase III KATHERINE results reinforce Kadcyla as the standard of care for this population, with more than 82,000 people treated to date Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study These data will be presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium and included in the official press program SOUTH SAN... Read More
Inavolisib in combination with palbociclib and fulvestrant more than doubled progression-free survival compared to palbociclib and fulvestrant alone The inavolisib combination has the potential to address resistance to treatment and poor prognosis associated with PIK3CA mutations These new data are being presented today in an oral presentation at the 2023 San Antonio Breast Cancer Symposium and shared with health authorities... Read More
Phase III (INAVO120) results shows that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the first-line setting PIK3CA mutations, found in approximately 40% of HR-positive breast cancers, are linked to tumor growth, disease progression, and treatment resistance Data will be shared with health authorities and presented at an upcoming medical meeting SOUTH SAN... Read More
Carmot Therapeutics’s R&D portfolio of clinical stage incretins has great potential to treat obesity, diabetes and potentially other diseases both as standalone medicines and in combination with Roche’s in-house assets Lead asset CT-388 is a Phase-2 ready dual GLP-1/GIP agonist with best-in-class potential for the treatment of obesity and its comorbidities Under the terms of the agreement, Roche will pay a purchase price of... Read More
Collaboration leverages expertise in artificial intelligence from Genentech and NVIDIA to unlock scientific innovation and empower R&D at a scale previously unattainable in pursuit of novel therapies Multi-year research effort aims to optimize and accelerate each company’s platforms and create innovations that could be applied in healthcare and beyond SOUTH SAN FRANCISCO, Calif. / Nov 21, 2023 / Business Wire / Genentech, a... Read More
The LightCycler PRO System is designed to be the most advanced qPCR technology for both clinical diagnostics and research. The new system will advance personalised healthcare and support outbreak readiness by delivering agility and flexibility for translational research and diagnostics. The innovative features of the system... Read More
RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration and diabetic macular edema Approval is based on two Phase III studies demonstrating early and sustained vision improvements that were non-inferior to aflibercept Vabysmo also demonstrated rapid and robust drying of retinal fluid Additional U.S. label update across indications includes information on rare... Read More
Roche's navify Digital Pathology software platform now offers Ibex's Artificial Intelligence (AI) algorithms to support clinicians in the diagnosis of breast and prostate cancer. Roche and Ibex cloud-based digital pathology and AI solutions run on Amazon Web Services (AWS), enabling a scalable and sustainable ecosystem for pathology laboratories. This collaboration builds on Roche's Digital Pathology Open Environment on the... Read More
These Phase III data are the first and only to show an improvement in disease-free survival in early-stage resected ALK-positive non-small cell lung cancer (NSCLC) With about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy, more effective treatment options are urgently needed to provide the best chance for cure Data are being presented as a... Read More
New data from Phase II FENopta study in relapsing multiple sclerosis (RMS) show fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS) More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at eight weeks The safety profile of fenebrutinib was consistent with... Read More
10-year efficacy data highlight Ocrevus’ impact on preventing disability progression and maintaining mobility in both relapsing and progressive forms of multiple sclerosis (MS) 10-year safety data from over 6,000 patients continue to reinforce consistent long-term safety profile of Ocrevus More than 3,200 women with MS treated with Ocrevus reported no increased risk in adverse pregnancy and infant outcomes with real-world... Read More
Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on Ocrevus levels in the blood over 12 weeks Ocrevus subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeks The safety profile of Ocrevus subcutaneous injection was consistent with the... Read More
Black and Hispanic / Latinx people with multiple sclerosis (MS) often experience more severe disease and greater disability Results from the Phase IV CHIMES trial demonstrate safety and efficacy consistent with data from the Ocrevus Phase III studies CHIMES sets new standard for inclusive research in MS, providing critical insights for improving clinical trial recruitment and retention among historically underrepresented... Read More
Vabysmo showed robust and sustained retinal drying up to 72 weeks and a safety profile consistent with previous trials If approved by the FDA, RVO would be Vabysmo’s third indication in addition to wet age-related macular degeneration (AMD) and diabetic macular edema (DME) Vabysmo is the first and only treatment that targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions SOUTH... Read More
RAINBOWFISH study met its primary endpoint with 80% of babies sitting without support for at least 5 seconds after 1 year of Evrysdi treatment — without treatment these babies would never be able to sit All babies were able to swallow and feed orally and none required permanent ventilation Evrysdi is the only non-invasive SMA therapy and is approved in over 100 countries with more than 11,000 patients treated globally SOUTH... Read More
Late-breaking results from Phase III trial of Ocrevus (ocrelizumab) subcutaneous injection and Phase II trial of BTK inhibitor fenebrutinib in multiple sclerosis (MS) will be presented 10-year Ocrevus efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MS Additional Ocrevus real-world and clinical data show impact for underrepresented... Read More
Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal hemoglobinuria (PNH) If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare setting Filing applications have also been accepted in the EU, China and Japan, and... Read More
The report shows digital health technologies demonstrate value, yet integrating them into care systems remains challenging. Involving healthcare professionals and patients in technology design and development is also critical for patient-centred care. 1 The report surveyed 10 countries, all of which have some foundations in place to use digital health technologies, such as regulatory frameworks and interoperability... Read More
ALINA data demonstrate Alecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced setting About half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cure These data will be... Read More
SOUTH SAN FRANCISCO, Calif. / Aug 23, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with... Read More
The cobas ® connection modules (CCM) sample conveyors system has been extended with newly developed elevator and overhead conveyor modules enabling more flexibility in lab design. CCM Vertical optimises the use of laboratory space without compromising on sample throughput of CCM up to 2,500 samples per hour. The fully modular system allows connection of different work areas in the laboratory without blocking walkways and... Read More
Ninety-four (94%) percent of global survey respondents working in healthcare agree that using data to drive healthcare creates new opportunities for patients and doctors to benefit from more personalised healthcare approaches. Yet 43% say disconnected or incompatible systems and data remain one of the greatest inhibitors to their organisation's ability to become more data-driven. Insufficient funding, organisational... Read More
Expanded alliance includes an agreement on eco social collaboration to jointly foster more sustainable diagnostic solutions, and the renewal of an agreement on hematology solutions for commercial and hospital laboratories, complementing the Roche Diagnostics portfolio 25-year partnership between Roche and Sysmex brings hematology testing innovations to laboratories and helps patients get access to routine hematology... Read More
Late-breaking post-hoc data indicate Vabysmo leads to less fibrosis, which may negatively impact vision, than aflibercept in people with diabetic macular edema (DME) Real-world data reinforce that first-line Vabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people with wet age-related macular degeneration (AMD) and DME Clinical data reiterate Vabysmo’s positive anatomical... Read More
Roche will unveil the next generation of core lab and molecular systems and cobas ® connection modules. Attendees can experience an integrated lab that goes beyond simply connecting individual technologies, demonstrating true end-to-end operational excellence. The Roche exhibit booth and Roche Idea Lab series featuring industry experts will highlight how our commitments to science, operational simplicity and partnership can... Read More
Phase III OCARINA II trial met primary and secondary endpoints Ocrevus 10-minute injection has the potential to further improve the treatment experience and expand Ocrevus® usage in MS centers with IV capacity limitations or without IV infrastructure Ocrevus remains the first and only therapy approved for both RMS and PPMS, and more than 300,000 people have been treated globally SOUTH SAN FRANCISCO, Calif. / Jul 13, 2023 /... Read More
Data from ongoing FIREFISH study confirm long-term efficacy and safety profile of Evrysdi in children with Type 1 SMA Ninety-one percent of children were alive at month 48 More than 95% maintained the ability to swallow - without treatment they would have required feeding support and majority would have died within 2 years Evrysdi is now approved in 99 countries with more than 8,500 patients treated globally SOUTH SAN... Read More
The Elecsys ® tTau/Abeta42 ratio helps clinicians define Alzheimer's disease (AD) biologically and expands Roche's AD CSF portfolio to include biomarkers for all three main pathological processes of Alzheimer's: amyloid plaques, tau tangles and neurodegeneration. Confirmation of amyloid pathology via CSF FDA-cleared... Read More
Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate, and a median duration of response of 1.5 years (18.4 months) Given over a fixed period of time, Columvi provides patients with a treatment end date and potential time off treatment Columvi is part of Genentech’s industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin’s lymphoma, which... Read More
The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors Monthly self-administration of subcutaneous crovalimab has the potential to address the high burden of a disease that requires lifelong treatment including in settings where access to current C5 inhibitors is limited The COMMODORE 1... Read More
Roche's Cerebrospinal Fluid (CSF) assays address unmet needs in the detection of amyloid pathology by offering greater accessibility and support for Alzheimer's disease (AD) diagnosis. Currently, AD diagnosis is largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan), providing accurate diagnosis in only 70-80% of cases. 1 Available across Canada , Roche's assays can measure... Read More
Roche will unveil the next generation of its serum work area, several molecular systems and the cobas ® connection module. The company will introduce navify ® digital solutions that help laboratories address their needs for digital infrastructure, operational excellence and medical insights. Attendees can experience an integrated lab that goes beyond simply connecting individual technologies to demonstrate true end-to-end... Read More
Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS) trials Phase II study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo... Read More
Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to aflibercept Application was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid If approved, RVO would be the third indication for Vabysmo in addition to wet age-related macular degeneration (AMD) and diabetic macular... Read More
Post-hoc analyses from four Phase III studies indicate Vabysmo dried retinal fluid faster with fewer injections in wet age-related macular degeneration (AMD) and diabetic macular edema (DME) More Vabysmo patients with wet AMD had absence of retinal fluid at 12 weeks in a post-hoc analysis from the Phase III TENAYA and LUCERNE studies DME patients treated with Vabysmo had less blood vessel leakage in the macula at 16 weeks in... Read More
Roche, Genentech and partners embark on global prevalence research, trend-spotting with digital analysis, and telehealth initiatives to assess & address deterrents to brain health to better understand holistic health journeys of patients with neurologic diseases Long-term data to be presented demonstrate delayed MS disability with Ocrevus; reduced disease activity with Enspryng in NMOSD and with Evrysdi in SMA Data from... Read More
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin’s lymphoma in the U.S. POLARIX trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profile First-line treatment... Read More
In the first-ever positive Phase III trial in the adjuvant hepatocellular carcinoma (HCC) setting, Tecentriq plus Avastin reduced the risk of disease recurrence by 28% Up to 80% of people with this type of HCC experience disease recurrence, at which point they are faced with poorer prognosis and shorter survival These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 and... Read More
Vabysmo data suggest rapid and robust drying of retinal fluid in patients with wet age-related macular degeneration and diabetic macular edema Real-world studies of Vabysmo demonstrate ability to extend treatment intervals in the first four months while maintaining visual acuity Clinical data on an investigational anti-interleukin-6 treatment in uveitic macular edema (UME) will be presented for the first time SOUTH SAN... Read More
At the global HIMSS 1 Conference, Roche showcases navify Algorithm Suite, a single platform offering clinicians access to medical algorithms generating insights to help improve care decisions. navify Algorithm Suite is a secure digital ecosystem that links physicians easily to a range of medical algorithms from Roche and its... Read More
SOUTH SAN FRANCISCO, Calif. / Mar 20, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data for Evrysdi ® (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study. Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to... Read More
SOUTH SAN FRANCISCO, Calif. / Mar 09, 2023 / 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) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favor of Polivy ® (polatuzumab vedotin-piiq) in combination with Rituxan ® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people... Read More
The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo monotherapy 1 based on the results of the Phase III EMPOWER-Lung 1 study. This additional approval will allow more patients with locally advanced and metastatic NSCLC broader access... Read More
It is critical to strengthen laboratories to enable more people to access quality testing and build stronger, resilient healthcare systems Public-private partnerships contribute to strengthening laboratory systems by leveraging the respective strengths, experience, and resources of the partners About 2 billion people worldwide are estimated to be infected with tuberculosis and more than 38 million people globally are living... Read More
SOUTH SAN FRANCISCO, Calif. / Feb 10, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive new data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks. The studies showed that treatment with Vabysmo resulted in early and... Read More
New agreement expands activities to include a wide-range of companion diagnostics, including tissue and blood-based biomarkers, sequencing and digital pathology. Collaboration builds on commitment to personalised healthcare through expanding access of companion diagnostics to enable targeted treatment options for patients. TUCSON, Ariz. , Feb. 9, 2023 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it... Read More
SOUTH SAN FRANCISCO, Calif. / Feb 07, 2023 / Business Wire / Genentech , a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints... Read More
Jana Care and Roche Diagnostics aim to develop point-of-care blood testing portfolio to address unmet needs for patients at-home and in remote settings. Jana Care's at-home testing platform to be distributed to global markets through Roche. WATERTOWN, Mass. , Jan. 30, 2023 /PRNewswire/ -- Jana Care , Inc. an early stage at-home In Vitro Diagnostics (IVD) company, and Roche Diagnostics (SIX: RO, ROG) (OTCQX: RHHBY), a global... Read More
Pivotal Phase III IMbrave050 study investigating Tecentriq plus Avastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survival New adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery Data will be discussed with health authorities globally,... Read More
If approved, glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin’s lymphoma Results from the pivotal Phase I/II NP30179 study showed glofitamab induced durable response rates in people with heavily pretreated large B-cell lymphoma, with 40% achieving a complete response Glofitamab is part of Genentech’s industry-leading portfolio... Read More
With Lunsumio, people with heavily pretreated follicular lymphoma (FL) may experience remission with a chemotherapy-free, fixed-duration treatment that can be accessed in an outpatient setting Results from the pivotal Phase II GO29781 study demonstrated that 80% of patients who received at least two prior therapies achieved durable response rates, with 60% experiencing complete remission Discovered and developed by Genentech... Read More
Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide Actemra is approved for this use in more than 30 countries for the treatment of COVID-19 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA)... Read More
The potential for a tripledemic exists, as influenza, COVID-19 and RSV cases rise. Two out of three Americans are confused by the differences between PCR and rapid antigen tests in detecting viruses and when to use them. It's important to know which test to use, as PCR testing is the best option for early detection, when... Read More
Data showcase the potential of glofitamab and Lunsumio to address diverse patient needs Data presented at ASH 2022 and simultaneously published in the New England Journal of Medicine showed that glofitamab , given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma 1,2 27-month follow-up data showed Lunsumio continued to induce high and durable responses in people... Read More
Updated data from the phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffus e large B-cell lymphoma (DLBCL) 1 Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes, during and after fixed-duration treatment, to those receiving the current standard-of-care,... Read More
The HAVEN 7 study was designed to further confirm the benefit of preventative treatment (prophylaxis) with Hemlibra from birth in previously untreated or minimally treated infants with severe haemophilia A without inhibitors In the study, 77.8% of participants had no bleeding episodes that required treatment 1 In addition, real-world efficacy and safety data from the EUHASS database and ATHN 7 study were also presented 2,3... Read More
Compass Therapeutics