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EMA’s CHMP recommends approval for AstraZeneca’s Saphnelo to treat SLE
Pharmaceutical-Business-Review
December 22, 2021
A fully human monoclonal antibody, Saphnelo targets subunit 1 of the type one interferon (type 1 IFN) receptor, blocking the type 1 IFN’s activity.
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EMA recommends GSK’s Xevudy for the treatment of COVID-19
EuropeanPharmaceuticalReview
December 22, 2021
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
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Saphnelo Recommended for Approval in the EU by CHMP for the Treatment of Patients with Systemic Lupus Erythematosus
AmericanPharmaceuticalReview
December 21, 2021
AstraZeneca’s Saphnelo (anifrolumab) has been recommended for marketing authorization in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe...
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CHMP recommend Saphnelo for systematic lupus erythematosus
pharmatimes
December 21, 2021
With approval, Saphnelo would be the first available treatment for systematic lupus erythematosus in Europe in over ten years.
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Merck Receives Positive EU CHMP Opinion for KEYTRUDA® as Adjuvant Therapy for Renal Cell Carcinoma
AmericanPharmaceuticalReview
December 20, 2021
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA...
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EMA CHMP advises use of Pfizer’s Covid-19 oral antiviral Paxlovid
Pharmaceutical-Technology
December 20, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the usage of Pfizer’s oral antiviral, Paxlovid (nirmatrelvir plus ritonavir), to treat adult Covid-19 patients.
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EMA CHMP recommends J&J’s Covid-19 booster for adults
Pharmaceutical-Technology
December 17, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion on the usage of Johnson & Johnson’s (J&J) Covid-19 vaccine as a booster shot for adults aged 18 years and above.
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Kineret receives positive CHMP opinion for treatment of COVID-19 pneumonia
pharmatimes
December 17, 2021
The European Medicines Agency has recommended approval for use of Kineret in COVID-19 to the European Commission, which will issue a final decision.
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EMA recommends RoActemra in adults with severe COVID-19
EuropeanPharmaceuticalReview
December 10, 2021
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra’s indication to include COVID-19 patients receiving systemic treatment.
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CHMP recommend approval for Roche’s COVID-19 therapy
PharmaTimes
December 08, 2021
According to clinical data, Roche’s new COVID-19 treatment Actemra/RoActemra lowered mortality risk in critically ill adult patients.