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.

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.

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.”

Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY™ as the first and only T-cell engaging bispecific antibody treatment in Japan of adult patients with certain types of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, after two or more lines of systemic therapy.

SpineThera, Inc. announced that the submitted abstract,” Clinically Meaningful Radicular Leg Pain Management via Novel Dexamethasone Extended Release Microsuspension - PH1/2 Results” has been accepted for presentation at the 22nd Annual Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine.

Vapotherm, Inc. announced the presentation of an Investigator-initiated clinical trial, “High flow humidified oxygen as an early intervention in children with acute severe asthma - a feasibility randomized controlled trial” at the European Respiratory Society International Congress 2023.

HilleVax, Inc. today announced that it has closed its previously announced underwritten public offering of 9,200,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 1,200,000 additional shares, at a price to the public of $12.50 per share.

Theratechnologies Inc. today announced that the Company has filed a supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the U.S. Food and Drug Administration (FDA) for review.

Cara Therapeutics, Inc. today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd. received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA ® IV Injection Syringe for the treatment of pruritus in hemodialysis patients.