Tag: Roche

FDA Cleared Roche Cobas Pro® Integrated Solutions to Optimize Lab Operations

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Roche Diagnostics announced that the US Food and Drug Administration (FDA) has cleared its cobas pro® integrated solutions, a new generation of Serum Work Area (clinical chemistry and immunochemistry)...

Roche OCREVUS Study Show Reduction of Disability Progression in Multiple Sclerosis

Roche announced longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with OCREVUS® (ocrelizumab) continuously for si...

Roche Presented Pivotal Phase III Study Results for Satralizumab

Roche presented full pivotal phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease. Resul...

EU Approved Roche’s Tecentric plus Chemotherapy for Treatment of ES-SCLC

Roche announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial...

Roche Extended Offering Period for Spark

On Sept. 3, 2019, Roche and Spark Therapeutics announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of Spark common ...

Roche’s Xofluza Reduce Risk of Flu after Contact with Infected Person

influenza vaccine
Roche announced that the phase III BLOCKSTONE study showed preventive treatment with XofluzaTM (baloxavir marboxil) after exposure to an infected household member significantly reduced the risk of peo...

Roche Announced Expanded Use of VENTANA PD-L1 Assay in Triple-Negative Breast Cancer

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Roche announced the expanded use of the VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européenne) markets where the Roche cancer immunothera...

EC Approved Roche’s Tecentriq®

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Roche announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® ) for the treatment of adult patients with unresectable locally advanced or metastatic ...

Study of Roche’s Tecentriq plus Platinum-Based Chemotherapy Met its Endpoint

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Roche announced that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival. The combination of Tecentriq® (atezolizumab) plus platinum-based ...

Sanofi Acquired from Roche Exclusive OTC Rights to Tamiflu® in the U.S.

Sanofi signed an agreement with Roche for the exclusive over-the-counter (OTC) rights to Tamiflu® for the prevention and treatment of influenza or flu in the US. Under the terms of the agreement, San...

Expanded Roche’s Global Access Program Now Includes MTB, HPV, Hepatitis B and C

Roche announced the Global Access Program is expanding beyond HIV, to include Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), and Human Papillomavirus (HPV) for low and middle incom...

Immuno-Oncology Imaging Company in Collaboration with Roche

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ImaginAb Inc., a clinical stage immuno-oncology imaging company, announced today that it has entered into a non-exclusive license and collaboration agreement with Roche. Under the terms of the agreeme...

Roche Extends Deadline for Acquisition of Spark Therapeutics by Three Months

Roche disclosed Monday in a filing with the US Securities and Exchange Commission that it will extend the deadline for closing its $4.3-billion acquisition of Spark Therapeutics by three months. Roche...

Primary Endpoint in Phase III Children Study Achived by Roche’s Flu Drug

Roche’s flu drug Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III Ministone-2 children study. The study has showed that Xofluza was well tolerated in children with flu. It al...

CHMP Recommended Roche’s Tecentriq for Treatment of Metastatic Triple-Negative Breast Cancer

Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®;...

Roche’s Personalised Medicine Rozlytrek Approved in Japan

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Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor ...