Roche ’s Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy
Basel, 30 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Evrysdi ™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disea se. The condition causes muscle weakness and progressive loss of movement and significant unmet need remains, particularly in adults living with this condition. (Source: Roche Media News)
Source: Roche Media News - March 30, 2021 Category: Pharmaceuticals Source Type: news
Roche receives positive CHMP opinion for Tecentriq as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer
Basel, 26 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Based on this recommendation, a final decision regarding the approval of Tecentriq in this disease setting, along with the full details of the ...
Source: Roche Media News - March 26, 2021 Category: Pharmaceuticals Source Type: news
Roche commences tender offer for all shares of GenMark Diagnostics, Inc. for $24.05 per share in cash
Basel, 25 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ: GNMK) at a price of $24.05 per share. The tender offer is being made pursuant to the previously announced merger ag reement dated as of March 12, 2021 among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Geronimo Acquisition Corp., a wholly owned subsidiary of Roche Holdings, Inc., and GenMark. (Source: Roche Media News)
Source: Roche Media News - March 25, 2021 Category: Pharmaceuticals Source Type: news
Roche launches new high throughput configurations for cobas pro integrated solutions to increase testing efficiency
Basel, 23 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of eight new configurations forcobas pro integrated solutions, in countries accepting the CE mark. As a result, this analyser can deliver up to 4,400 tests per hour, doubling its previous testing capacity.1 This makes it the ideal choice for labs seeking greater flexibility in ramping up their testing capacity, to adapt to evolving clinical chemistry and immunochemistry testing needs. Today, the importance of accurate and timely diagnostic testing can be felt across the globe. Growing testing demands put laboratories under significant pr...
Source: Roche Media News - March 23, 2021 Category: Pharmaceuticals Source Type: news
New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19
Basel, 23 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). The phase III outcomes trial in high-risk non-hospitalised patients with COVID-19 met its primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab reduced the risk of hospitalisation or death by 70% (1,200 mg intravenously [IV]) and 71% (2,400 mg IV) compared to placebo. Casirivimab and imdevimab also met all key secondary endpoints in the p...
Source: Roche Media News - March 23, 2021 Category: Pharmaceuticals Source Type: news
Roche provides update on tominersen programme in manifest Huntington ’s disease
Basel, 22 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington ’s disease (HD). The decision was based on the results of a pre-planned review of the data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). The iDMC made its recommendation based on the investigational therapy’s potential benefit/risk profile for s tudy participants. No new or emerging safety signals were identified for tominersen in the review of the data from this...
Source: Roche Media News - March 22, 2021 Category: Pharmaceuticals Source Type: news
Pivotal Phase III study shows Roche ’s Tecentriq helped people with early lung cancer live longer without their disease returning
Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower010 study evaluating Tecentriq® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant im provement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population. Follow-up will continue with planned analyses of DFS in the ...
Source: Roche Media News - March 22, 2021 Category: Pharmaceuticals Source Type: news
Roche launches cobas pure integrated solutions analyser to help simplify operations in small to medium sized labs
Basel, 17 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch ofcobas pure integrated solutions in countries accepting the CE mark.3 This new compact analyser combines three technologies1 on a single platform helping to simplify daily operations in labs with limited space and resources. (Source: Roche Media News)
Source: Roche Media News - March 17, 2021 Category: Pharmaceuticals Source Type: news
Roche Annual General Meeting 2021
Basel, 16 March 2021 - 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 pandemic restrictions, the AGM was held with only those persons required by the Articles of Incorporation in attendance and with no shareholders physically present. Roche shareholders were able to exercise their rights via written or electronically submitted instructions to the independent proxy, Testaris AG. The independent proxy represented 84.58% of the total of 160,000,000 shares. The Management Report, the Annual Fina...
Source: Roche Media News - March 16, 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
New two-year data show Roche ’s Evrysdi (risdiplam) continues to demonstrate improvement or maintenance of motor function in people aged 2-25 with Type 2 or Type 3 Spinal Muscular Atrophy (SMA)
Basel, 16 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new exploratory 2-year longer-term data from Part 2 of SUNFISH, a global placebo-controlled study evaluating Evrysdi ™ (risdiplam) in people aged 2-25 years with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). The study suggests that gains in motor function observed with Evrysdi treatment at month 12 continued to improve or were maintained at month 24 across primary and secondary endpoint measures. Based on the natural history of the disease, people with Types 2 and 3 SMA who remain untreated decline in motor function over time. These ...
Source: Roche Media News - March 16, 2021 Category: Pharmaceuticals Source Type: news
Roche signs definitive merger agreement with GenMark Diagnostics, Inc., to access novel technology to test for broad range of pathogens with one patient sample
Roche and GenMark Diagnostics (NASDAQ: GNMK) today announced that they have entered into a definitive merger agreement for Roche to fully acquire GenMark at a price of US$ 24.05 per share in an all-cash transaction. (Source: Roche Media News)
Source: Roche Media News - March 15, 2021 Category: Pharmaceuticals Source Type: news
Roche awarded WHO prequalification for the HIV and HCV tests on the cobas 6800/8800 Systems
Basel, 11 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas ® HIV-1 and cobas® HCV Tests for use on the cobas® 6800/8800 Systems have been awarded World Health Organization (WHO) prequalification. WHO prequalification helps regulators and procurers in low and middle-income countries to identify products that meet high quality standards and are safe and su itable for their intended use. This is of benefit to healthcare professionals and patients, for whom quality assured IVDs are essential for effective diagnosis and monitoring of therapeutic efficiency. Increased access to diagnostic testi...
Source: Roche Media News - March 11, 2021 Category: Pharmaceuticals Source Type: news
Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia
Basel, 11 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the global phase III randomised, double-blind, multicentre REMDACTA study of Actemra ®/RoActemra® (tocilizumab) plus Veklury® (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint. This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra/RoActemra in the REMDACTA trial. The study was conducted in collaboration with Gilead Sciences, Inc. (Source: Roche Media News)
Source: Roche Media News - March 11, 2021 Category: Pharmaceuticals Source Type: news
Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer
This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population. Subsequently, the FDA designated the IMvigor130 study as the PMR which will still continue until the final analysis. However, as the treatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergence of new treatment options, Roche is voluntarily withdrawing this indication in recognition of the principles of the Accelerated Approval Program.About Tecentriq Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour c...
Source: Roche Media News - March 8, 2021 Category: Pharmaceuticals Source Type: news
