BioSpace News Archive

FDA

FDA Approves Luye Pharma’s Rykindo® for the Treatment of Schizophrenia and Bipolar 1 Disorder

Luye Pharma Group announced that the U.S. Food and Drug Administration has approved Rykindo® for extended-release injectable suspension for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

January 15, 2023
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8 min read
Genetown

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril1 antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency.

January 15, 2023
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22 min read
Drug Development

Ascletis Announces Dosing of 4 Healthy Subjects of the First Cohort in Multiple-Dose Escalation Phase I Clinical Trial of Oral 3CLpro Inhibitor ASC11 for COVID-19

Ascletis Pharma Inc. announces dosing of 4 healthy subjects of the first cohort in multiple-dose escalation Phase I clinical trial of oral 3-chymotrypsin like protease inhibitor ASC11 in combination with 100 mg ritonavir tablets for COVID-19.

January 15, 2023
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3 min read
Drug Development

Clover Provides Updates on COVID-19 Vaccine Commercial Launch and Strategic Priorities in 2023

Clover Biopharmaceuticals, Ltd., a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, provided updates on the commercialization of SCB-2019 in China and strategic priorities in 2023.

January 15, 2023
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15 min read
Drug Development

BioArctic’s partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer’s disease in Japan

BioArctic AB’s partner Eisai announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril[1] antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency.

January 15, 2023
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19 min read