BioSpace News Archive

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.

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.”

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.

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

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.

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.

Ardelyx, Inc. announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd., has received approval from the Japanese Ministry of Health, Labour and Welfare for the New Drug Application for tenapanor for the improvement of hyperphosphatemia in adult patients with chronic kidney disease on dialysis.

Biosynth is pleased to announce the acquisition of Pepceuticals, a UK producer of synthetic peptides with multi-kilogram GMP facilities and fill-finish capabilities designed to support customers from clinical trials to commercial supply.

Mikart, LLC is pleased to announce its recent acquisition of the state-of-the-art Flexpack NF-150 Horizontal Sachet-Packaging Machine.