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Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy
Basel, 18 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company ' s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. The VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (MMR), who may be eligible for JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GSK. The test evaluates a panel of MMR pro...
Source: Roche Media News - August 18, 2021 Category: Pharmaceuticals Source Type: news

US FDA grants Priority Review to Roche ’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
Basel, 3 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-appro ved test. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective ...
Source: Roche Media News - August 3, 2021 Category: Pharmaceuticals Source Type: news

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine ap...
Source: Roche Media News - April 27, 2021 Category: Pharmaceuticals Source Type: news

NIDCR's Spring 2021 E-Newsletter
Having trouble viewing this email? View it as a Web page. NIDCR's Spring 2021 E-Newsletter In this issue: NIDCR News Funding Opportunities & Related Notices NIH/HHS News Subscribe to NICDR News Science Advances   Grantee News   NIDCR News NIDCR & NIH Stand Against Structural Racism NIDCR Director Rena D’Souza, DDS, MS, PhD, said in a statement that there is no place for structural racism in biomedical research, echoing remarks from NIH Director Francis Collins, MD, PhD, in his announcement of a new NIH initiative—called UNIT...
Source: NIDCR Science News - April 7, 2021 Category: Dentistry 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 Investor Update - March 22, 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

European Commission approves Roche ’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
Basel, 2 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Tecentriq in combination with Avastin is the first treatment to be approved in over a decade that has improved overall survival for people with previously untreated advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of...
Source: Roche Media News - November 2, 2020 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
             Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changing the treatment landscape for this aggressive disease”, said Levi Ga...
Source: Roche Investor Update - October 29, 2020 Category: Pharmaceuticals Source Type: news

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