Tag: Roche

NICE Rejected Roche’s Tecentriq for Untreated SCLC in Adults

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The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance against routine NHS coverage for Roche's Tecentriq (atezolizumab) in combination with carboplatin and etoposid...

Roche and Sarepta Signed Licensing Agreement on SRP-9001

Roche and Sarepta Therapeutics, Inc., announced the signing of a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sarepta’s investigational...

European Commission Approved Roche Kadcyla®

Roche announced that the European Commission has approved Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who...

Rheos Signed Exclusive Collaboration, Option and License Agreement with Roche

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Rheos Medicines (Rheos), a biopharmaceutical company harnessing insights in immunometabolism to create a new class of therapeutics for patients with severe autoimmune disorders, inflammatory diseases ...

Roche Completed Acquisition of Spark Therapeutics

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Roche and Spark Therapeutics, Inc. announced the completion of the acquisition following the receipt of regulatory approval from all government authorities required by the merger agreement. Comment...

UK Cleared Roche’s Proposed Purchase of Spark Therapeutics

The UK Competition and Markets Authority announced the clearance of Roche's proposed purchase of Spark Therapeutics after concluding that the deal would not negatively affect competition for haemophil...

Roche Updated Data from Phase III Venclexta®/Venclyxto® Studies

clinical-trial
Roche announced updated data from two pivotal phase III Venclexta®/Venclyxto® (venetoclax) studies (MURANO and CLL14) that highlight Venclexta/Venclyxto combination treatments as chemotherapy-free, fi...

FDA Approved New Diagnostic Test Based on Bacterial Viability

The U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacte...

Roche Secured FDA Approval for Tecentriq for NSCLC Treatment

Roche has secured approval from the US Food and Drug Administration (FDA) for its Tecentriq (atezolizumab) plus chemotherapy for the initial treatment of metastatic non-squamous non-small cell lung ca...

Positive Results from Satralizumab Study Support Hypothesis that IL-6 Plays Key Role in NMOSD

Roche announced that data from SAkuraSky, a pivotal phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), were published in ...

Roche Acquired Clinical-Stage Biotechnology Company Promedior for $1,4bn

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Roche has agreed to acquire US-based clinical-stage biotechnology company Promedior in a deal valued at around $1.39bn. As per terms of the merger deal, Promedior will secure an upfront cash pa...

Roche Announced Positive Data from Study Evaluating Risdiplam

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Roche announced positive data from the pivotal Part 2 of SUNFISH, a study evaluating risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA). The study met its primary en...

Roche’s Gazyva® Proved its Safety and Effectiveness

preclinical-research
Roche announced data from the phase II NOBILITY study, investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. The study met the primary endpo...

EMA and FDA Accepted for Review Roche’s Marketing Applications for Satralizumab

Roche announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application for satralizumab for the treatment of adult and adolescent patients with neurom...

FTC Recommended to Approve Roche’s Proposed Purchase of Spark Therapeutics

According to a report in The Capitol Forum, the staff at the US Federal Trade Commission (FTC) recommended that Roche's proposed $4.3-billion purchase of Spark Therapeutics be approved without requiri...

Roche Subbmitted Application for Xofluza to Russian Ministry of Health

Roche announced the filing with the Ministry of Health of the Russian Federation of an application for registration of the drug baloxavir marboxil (Xofluza®). The registration dossier is based on d...