October 18, 2019 / 11:12 AM / a month ago

BRIEF-EMA Says CHMP Recommends Conditional Marketing Authorisation For Ebola Vaccine Ervebo

Oct 18 (Reuters) - European Medicines Agency:

* CHMP RECOMMENDS GRANTING CONDITIONAL MARKETING AUTHORISATION FOR ERVEBO FOR ACTIVE IMMUNISATION OF PEOPLE ABOVE 18 YEARS AT RISK OF EBOLA VIRUS

* CHMP ADOPTED NEGATIVE OPINION FOR VANFLYTA (QUIZARTINIB); VANFLYTA WAS EXPECTED TO BE USED TO TREAT ADULTS WITH ACUTE MYELOID LEUKAEMIA

* CHMP RECOMMENDED GRANTING A MARKETING AUTHORISATION FOR BAQSIMI (GLUCAGON), TREATMENT FOR SEVERE HYPOGLYCAEMIA

* QUOFENIX (DELAFLOXACIN) RECEIVED A POSITIVE OPINION FROM CHMP FOR TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

* SPRAVATO (ESKETAMINE) GOT POSITIVE OPINION FROM CHMP FOR COMBINATION TREATMENT IN ADULTS WITH TREATMENT-RESISTANT MAJOR DEPRESSIVE DISORDER

* CHMP RECOMMENDED GRANTING A MARKETING AUTHORISATION FOR RINVOQ (UPADACITINIB) FOR TREATMENT OF RHEUMATOID ARTHRITIS

* CHMP ADOPTED A NEGATIVE OPINION RECOMMENDING REFUSAL OF A MARKETING AUTHORISATION FOR HOPVEUS (SODIUM OXYBATE)

* CHMP RE-EXAMINED INITIAL OPINIONS FOR REVOLADE (ELTROMBOPAG) AND TRANSLARNA (ATALUREN) AND CONFIRMED PREVIOUS RECOMMENDATIONS Further company coverage:

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