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BioWorld - Saturday, May 30, 2026
Home » Topics » Regulatory » CHMP

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EU flag and pills
Rolling with remdesivir

EMA begins remdesivir review, as CHMP recommends eight new meds for approval

May 1, 2020
By Michael Fitzhugh
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
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Zolgensma product packaging

CHMP nods through multiple applications during virtual March meeting

March 27, 2020
By Cormac Sheridan
DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually.
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EU flag, pills, syringe

CHMP nixes Lilly bid to broaden Emgality label in migraine

Feb. 28, 2020
By Cormac Sheridan
DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.
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EU panel CHMPions varied batch of prospective new therapies

Jan. 31, 2020
By Randy Osborne
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
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