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Source: Roche Media News
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Total 20 results found since Jan 2013.
Roche launches COVID-19 PCR test to detect the fast spreading XBB.1.5 Omicron sub-variant
This new test for researchers specifically targets the XBB.1.5 Omicron sub-variant and runs on the real-time PCR platformsLightCycler® 480 II* andcobas® z480.Results from the test will help closely track the virus ’ lineage and provide insights into the epidemiology and impact it has on public health.Concern from the World HealthOrganisationcentres around the XBB.1.5 high transmissibility and growth advantage.1Basel, 26 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and its subsidiary TIB Molbiol have developed a COVID-19 PCR test for researchers that detects and differentiates the latest variant of concern, XBB.1.5...
Source: Roche Media News - January 26, 2023 Category: Pharmaceuticals Source Type: news
Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems
Thecobas SARS-CoV-2 Qualitative test is one of the first COVID-19PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance.This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing beyond the EUA period.Based on continuous analysis performed since the onset of the pandemic, all Roche molecular tests, including thecobas SARS-CoV-2 Qualitative test, detect all SARS-CoV-2 variants.Basel, 24 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) c...
Source: Roche Media News - October 24, 2022 Category: Pharmaceuticals Source Type: news
U.S. FDA grants priority review to Roche ’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
If approved,Actemra/RoActemra would be the first U.S. FDA-approvedimmunomodulator for the treatment of COVID-19 inhospitalised patientsSince the beginning of the pandemic, more than one million peoplehospitalised with COVID-19 have been treated withActemra/RoActemra worldwide1Actemra/RoActemra is approved for the treatment of COVID-19 in many territories including the European UnionRoche has established a comprehensive access approach to improve availability ofActemra/RoActemra around the worldBasel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has acce...
Source: Roche Media News - April 4, 2022 Category: Pharmaceuticals Source Type: news
Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern
Roche and its subsidiary,TibMolbiol, confirm that it has tests for research use that identify the SARS-CoV-2subvariants of concern, Omicron: BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and DeltaThe World Health Organization (WHO) has recently reported that the BA.2subvariant is steadily increasing in prevalence, specifically in Denmark Use of these tests assess the spread of circulating variants and can help monitor the potential impact of therapeutics, vaccines and public health interventionsAll Roche SARS-Cov-2 tests correctly identify the virus including these newsubvariantsBasel, 16 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)...
Source: Roche Media News - March 16, 2022 Category: Pharmaceuticals Source Type: news
Roche Annual General Meeting 2022
All proposals of the Board of Directors approvedChristoph Franz as Chairman of the Roche Board of Directors and all other Board members standing for re-election approved;Jemilah Mahmood elected as a new member of the Board of Directors35th Consecutive dividend increase to CHF 9.30 per shareBasel, 15 March 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). Owing to the ongoing high infection rates, the AGM was held with only representatives of Roche Holding Ltd and those persons req uired by the Arti...
Source: Roche Media News - March 15, 2022 Category: Pharmaceuticals Source Type: news
Roche has rapidly developed additional testing options to differentiate mutations in the Omicron SARS-CoV-2 variant
Basel, 3 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and TIB Molbiol, a newly acquired subsidiary within the Roche Diagnostics division, have added three additional Research Use Only (RUO) test kits for the detection of mutations present in the novel B.1.1.529 Omicron SARS-CoV-2 variant: VirSNip SARS Spike ins214EPE (RUO), VirSNiP SARS-CoV-2 Spike S371L S373P (RUO), VirSNip SARS Spike E484A (RUO). The World Health Organization (WHO) has classified the recently emerged SARS-CoV-2 variant, Omicron (B.1.1.529), as a COVID-19 variant of concern (VOC).The VirSNiP variant kits allow differentiation between unique mutation...
Source: Roche Media News - December 3, 2021 Category: Pharmaceuticals Source Type: news
Ad hoc announcement pursuant to Art. 53 LR Roche reports strong growth in the first nine months – outlook for 2021 raised
CEO Severin Schwan on the results: “The demand for coronavirus tests remained high in the third quarter due to the Delta variant.
Source: Roche Media News - October 20, 2021 Category: Pharmaceuticals Source Type: news
Roche launches SARS-CoV-2 variant test to help monitor emerging coronavirus mutations
Basel, 16 March 2021- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for healthcare systems in making appropriate measures to combat COVID-19. Variants of B.1.1.7, B.1.351 and P.1 lineage gained prominence in late 2020, with each carry...
Source: Roche Media News - March 16, 2021 Category: Pharmaceuticals Source Type: news
Roche Annual General Meeting 2021: Exercising of shareholder rights via the independent proxy
Basel, 18 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that unfortunately it will not be possible for shareholders to attend the Annual General Meeting in person owing to the ongoing pandemic. Our main concern is to protect our shareholders from any potential health risks that may arise because of the ongoing difficult pandemic situation. As a precautionary and prudent measure, the Board of Directors has decided to conduct the Annual General Meeting of Roche Holding Ltd on Tuesday, 16 March 2021, in accordance with Art. 8 of the Federal Act on the Statutory Principles for Federal Council Ordinances on ...
Source: Roche Media News - January 18, 2021 Category: Pharmaceuticals Source Type: news
Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
Basel, 11 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.
Source: Roche Media News - December 11, 2020 Category: Pharmaceuticals Source Type: news
Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person
Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Le...
Source: Roche Media News - November 24, 2020 Category: Pharmaceuticals Source Type: news
Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
Roche announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
Source: Roche Media News - October 13, 2020 Category: Pharmaceuticals Source Type: news
Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys ® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA). The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 Specifically, the test targets antibodies which are directed against the par...
Source: Roche Media News - September 18, 2020 Category: Pharmaceuticals Source Type: news
Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems
Basel, 04 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas ® SARS-CoV-2& Influenza A/B Test for use on the cobas ® 6800/8800 Systems has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE mark.“With the approaching flu season, this new test is p...
Source: Roche Media News - September 4, 2020 Category: Pharmaceuticals Source Type: news
Roche ’s Elecsys IL-6 test receives FDA Emergency Use Authorisation to help in identifying patients at high risk of severe inflammatory response
Basel, 04 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirm ed COVID-19 disease who could be at high risk of intubation with mechanical ventilation. The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation. “The F...
Source: Roche Media News - June 4, 2020 Category: Pharmaceuticals Source Type: news
