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European Medicines Agency (EMA)

CHMP initiates rolling review of molnupiravir for COVID-19

26 October 2021 | By Anna Begley (European Pharmaceutical Review)

The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.

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Comirnaty^® booster dose displays high efficacy in Phase III study

22 October 2021 | By Anna Begley (European Pharmaceutical Review)

The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.

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EMA approve Comirnaty^®and Spikevax booster doses

7 October 2021 | By Anna Begley (European Pharmaceutical Review)

The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.

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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021

6 October 2021 | By Anna Begley (European Pharmaceutical Review)

The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.

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EMA evaluate booster dose of COVID-19 vaccine Spikevax

28 September 2021 | By Anna Begley (European Pharmaceutical Review)

The European Medicines Agency (EMA) is evaluating an application for the use of a booster dose of Spikevax in people aged 12 years and older.

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Comirnaty^® effective in children aged five to 11 years

21 September 2021 | By Anna Begley (European Pharmaceutical Review)

Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.

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EMA’s human medicines committee (CHMP) September meeting highlights

20 September 2021 | By Anna Begley (European Pharmaceutical Review)

In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.

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EMA evaluates data on Comirnaty^® COVID-19 vaccine booster dose

8 September 2021 | By Anna Begley (European Pharmaceutical Review)

EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.

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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021

7 September 2021 | By Anna Begley (European Pharmaceutical Review)

The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.

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EC approves Ultomiris for children and adolescents with PNH

3 September 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).

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FDA application to be submitted for Comirnaty^® booster dose

26 August 2021 | By Anna Begley (European Pharmaceutical Review)

Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.

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Comirnaty and Moderna COVID-19 vaccine supply to increase in the EU

25 August 2021 | By Anna Begley (European Pharmaceutical Review)

The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.

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Evrenzo™ approved for CKD-related anaemia treatment in EU

23 August 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) has approved Astellas’ Evrenzo™ for adult patients with symptomatic anaemia of chronic kidney disease (CKD).

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Abecma is the first treatment approved by EC for multiple myeloma

20 August 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) has approved Abecma, the first anti-BCMA CAR T-cell therapy for patients with multiple myeloma.

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MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds

18 August 2021 | By Anna Begley (European Pharmaceutical Review)

The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.

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European Medicines Agency (EMA)