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WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19
WorldPharmaNews
February 15, 2022
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Actemra®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification.
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Roche gets FDA priority review for Evrysdi to treat SMA in new-borns
pharmaceutical-business-review
January 27, 2022
Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) priority review for its Evrysdi...
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European Commission approves Actemra/RoActemra by Roche to treat severe COVID-19
expresspharma
December 13, 2021
Approval based on results from four phase-III studies in more than 5,500 patients
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EMA Expands Authorization for Roche’s Actemra/RoActemra in COVID
contractpharma
December 08, 2021
An accelerated assessment by the EMA’s CHMP reviewed results from four studies of Actemra/RoActemra in over 5,500 patients with severe or critical COVID-19.
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EMA CHMP recommends granting approval for Roche’s therapy to treat Covid-19
Pharmaceutical-Technology
December 08, 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EU marketing authorisation for Roche’s Actemra/RoActemra (tocilizumab) to treat adult Covid-19 patients.
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Roche completed the repurchase of Roche shares from Novartis
WorldPharmaNews
December 07, 2021
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it completed the repurchase of Roche shares that had been held by Novartis. On 4 November 2021, Roche and Novartis had announced this repurchase. The Extraordinary General Meeting of Roche Holding...
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EC approves Roche’s Ronapreve for Covid-19 treatment
Pharmaceutical-Business-Review
November 16, 2021
The European Commission (EC) has granted marketing authorisation for Roche’s Ronapreve to treat non-hospitalised Covid-19 patients aged 12 years and above.
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CHMP recommends EU approval of Ronapreve to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease
WorldPharmaNews
November 12, 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 the antibody...
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US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for non-small cell lung cancer
expresspharma
August 04, 2021
Tecentriq is the first and only cancer immunotherapy to demonstrate positive phase-III results in the adjuvant lung cancer setting.
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Roche’s Evrysdi significantly improves lives of babies with SMA
europeanpharmaceuticalreview
August 02, 2021
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).