Category: Europe

March 29, 2022 Off

FDA Approves Moderna’s Second Booster

By Author

Moderna, Inc. (NASDAQ:MRNA) has received approval from the U.S. Food and Drug Administration (FDA) for its amendment to the emergency use authorization (EUA) to allow for a second booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level in adults 50 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines and adults 18 years of age and older with certain kinds of immunocompromise.

Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy
March 29, 2022 Off

Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy

By Dino Mustafić

Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) have announced the initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Vamorolone for DMD has been granted Fast Track Designation by the FDA.

AstraZeneca’s Evusheld Approved in the EU for Prevention of COVID-19
March 28, 2022 Off

AstraZeneca’s Evusheld Approved in the EU for Prevention of COVID-19

By Dino Mustafić

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Xenpozyme (olipudase alfa) Approved in Japan, First and Only Approved Therapy Indicated to Treat Acid Sphingomyelinase Deficiency
March 28, 2022 Off

Xenpozyme (olipudase alfa) Approved in Japan, First and Only Approved Therapy Indicated to Treat Acid Sphingomyelinase Deficiency

By Dino Mustafić

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Xenpozyme (olipudase alfa) for the treatment of adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease.

Publication of definitive end result for Vifor Pharma tender offer
March 28, 2022 Off

Publication of definitive end result for Vifor Pharma tender offer

By Dino Mustafić

CSL Behring AG, Berne, Switzerland, a wholly-owned subsidiary of CSL Limited (ASX: CSL; USOTC: CSLLY), have announced the definitive notice of the end result of its public tender offer to acquire all publicly held shares of Vifor Pharma Ltd. (SIX:VIFN; ISIN:CH0364749348) for USD 179.25 per share as indicated in the offer prospectus of 18 January 2022.