BioSpace News Archive

Despite meeting the primary endpoint and eliciting endoscopic improvements in ulcerative colitis, Morphic Therapeutic’s investigational pill underwhelmed investors with its stock plummeting.

The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.

After dropping an early-stage study more than a year ago, AbbVie has finally terminated its CD47 collaboration with I-Mab, leaving up to $1.3 billion in potential milestone payments on the table.

The FDA’s briefing documents found that BrainStorm’s BLA submission for its investigational cell therapy for ALS did not demonstrate evidence of effectiveness and that the manufacturing data was “grossly deficient.”

BioArctic AB’s partner Eisai announced that “LEQEMBI® Intravenous Infusion” has been approved in Japan as a treatment for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease.

Glycotope GmbH and the Max Delbrück Center for Molecular Medicine in the Helmholtz Association have signed an agreement to explore the potential of combining Glycotope’s antibodies against protein/carbohydrate combined glyco-epitopes with chimeric antigen receptor technology developed by the Max Delbrück Center.

The Japanese Ministry of Health, Labor, and Welfare has granted marketing authorization for ALTUVIIIO®, a first-in-class, high-sustained factor VIII replacement therapy.

Pierre Fabre Laboratories and Vernalis Ltd, a fully owned subsidiary of HitGen Inc., are pleased to announce a long-term partnership to identify pre-clinical candidates against multiple oncology targets.

On September 15, “Kexing Biopharm 2023 Innovation Forum on Targeted Drug Delivery” successfully kicked off.

Alvotech announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd., has received marketing approval for AVT04, a biosimilar to Stelara®, from the Japanese Ministry of Health, Labor and Welfare.