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.”

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.

Elite Pharmaceuticals, Inc. announced that it filed an Abbreviated New Drug Application on August 17, 2023, and was accepted for review by the US Food and Drug Administration on September 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics.

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.

Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart , the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human.

Ginkgo Bioworks and the Government of the Republic of Madagascar today announced that they have entered into a Memorandum of Understanding (“MOU”) with the intent to develop and implement new biosecurity capabilities in Madagascar.

Castle Biosciences, Inc. today announced that the Company will ring the Nasdaq closing bell on Wednesday, Sept. 27, 2023, to raise awareness of melanoma in honor of patients impacted by the disease.