Tag: Roche

Roche ventures into Indian market with its muscular atrophy prescription drug

Frank

SWITZERLAND – Pharmaceutical giant, Roche have launched a prescription medicine Evrysdi in India, which is used for treatment of spinal muscular atrophy (SMA) in adults, children aged 2 months and older. Evrysdi was first approved by the United States Food and Drug Administration (US FDA) in August 2020 and is now available in India within 11 months of the US approval. Since its launch, over 4,000 SMA patients across over 50 countries have benefited from the drug, this is according to Roche. Roche has also had its data related to…

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Roche’s blood therapy portfolio expanding following FDA’s approval of Venclexta

Frank

SWITZERLAND – Roche’s Venclexta has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS). This designation was granted based on interim results from the phase 1b M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated, higher-risk MDS. The approval will become the 38th BTD for Roche’s portfolio of medicines, and the 11th designation for its haematology portfolio. In the US, Venclexta has been granted six BTDs…

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Japan approves Roche’s therapy for mild to moderate COVID-19 symptoms

Frank

SWITZERLAND – Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Roche’s Ronapreve (casirivimab and imdevimab), for the treatment of non-hospitalized patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. This approval was an onset of results from the global phase III study in high-risk non-hospitalized patients with COVID-19. Outside Japan, the antibody combination has been authorized for emergency use or temporary pandemic use in additional territories and regions, including…

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Roche presents updated clinical trial data for hemlibra

Frank

SWITZERLAND – Roche has released results for its haemophilia A therapy candidate, Hemlibra which confirm that its has a favorable safety profile. In the analysis, no new safety signals were identified with long-term Hemlibra treatment in adults and adolescents with haemophilia A having inhibitors to factor VIII, the clotting protein that is missing or defective in people with haemophilia A. STASEY study data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, held from 17-21 July 2021. Final analysis of the STASEY study included data…

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Roche’s tuberculosis diagnostic tests included in new WHO expansion guidelines for tuberculosis

Frank

SWITZERLAND – The Swiss based pharma company, Roche, now has its diagnostic tests included in World Health Organization (WHO) newly expanded tuberculosis guidelines. WHOs guidelines on nucleic acid amplification tests (NAATs) to detect tuberculosis (TB) and drug resistant TB post its expansion will now have increased number of molecular tests available to national TB programs in high-burden countries. The WHO included Roche’s diagnostic test, the Cobas MTB and Cobas MTB-RIF/INH tests, to enable multi-partner diagnostic approaches that can benefit patients and communities. Cobas MTB and cobas MTB-RIF/INH molecular tests provide…

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Merck and BioMedX set to partner as they strive to bolster their fight against cancer in a new joint cancer research programme

Frank

GERMANY – German based pharma company, Merck, and BioMed X, an independent research institute located at the University of Heidelberg in Germany have partnered to focus on their oncology related research. This is the eighth collaboration between the two organizations and is set to explore the role of extrachromosomal DNA (ecDNA) in cancer. BioMedX currently has two other ongoing oncology related programmes focused on DNA damage response and RNA splicing that this new research program is set to compliment. Extrachromosomal DNA (ecDNA) is any DNA that is found off the…

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Roche set to participate at International Society on Thrombosis and Haemostasis 2021 congress

Frank

SWITZERLAND – Roche is set to participate in the International Society on Thrombosis and Haemostasis (ISTH) 2021 congress with new data on standard care for Haemophilia A. This virtual event will have Roche provide data that will include final analysis from the phase 3b STASEY study of Hemlibra (emicizumab) and updated data from the phase I/II study of SPK-8011, an AAV-based gene therapy in development by Spark Therapeutics (a member of the Roche Group). Roche’s STASEY study is one of the largest open-label studies primarily assessing the safety and tolerability…

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European Commission approves Roche’s enspryng as the first and only at home treatment for neuromyelitis optica spectrum disorder

Frank

SWITZERLAND – European Commission (EC) has approved Roche’s Enspryng (satralizumab) used to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). ENSPRYNG is the first and only NMOSD treatment that is administered subcutaneously (injection under the skin) every four weeks, allowing home-dosing after appropriate training. The EC approval is supported by results from two Phase III studies, in which ENSPRYNG showed robust and sustained efficacy in reducing the risk…

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Roche launches first cancer treatment center in Ghana for effective cancer care

Frank

GHANA – Roche, a global pioneer in pharmaceuticals and diagnostics and the leading provider of cancer treatments globally, has launched a cancer treatment center at the Cape Coast Teaching Hospital (CCTH) for accessible and effective cancer care in the Region and beyond. It is the first of three cancer centers to be established by Roche, in collaboration with the Ministry of Health to provide and promote effective and efficient cancer care and bring treatment closer to the door steps of people affected with the disease. The launch coincided with the…

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