BioSpace News Archive

After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.

Two Democratic senators on Thursday sent a letter to the companies’ CEOs informing them that they have until Sept. 15 to disclose the application processes for their insulin assistance programs.

$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.

The antibody-drug conjugate will be pitted against chemotherapy in a heavily treated breast cancer subpopulation, with hopes of challenging AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu.

Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.

The vaccine was effective against previous COVID-19 variants but lacked efficacy against new ones, the company announced Thursday, leaving the booster no commercially viable options.

ABM Therapeutics, a clinical-stage biopharmaceutical company, today announced that the first patient has been successfully dosed in its multicenter Phase I study of ABM-1310 in patients with relapsed and drug resistant primary malignant brain tumors in China. This is the second clinical study of ABM-1310 in China.

Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit.

Umoja Biopharma, Inc. today announced new data from an ongoing non-human primate (NHP) study demonstrating effective, durable, and well tolerated in vivo chimeric antigen receptor (CAR) T cell generation using the Company’s VivoVec™ platform technology at the 8th CAR-TCR Summit taking place in Boston, MA, August 29 - September 1, 2023.

Alliance for Multispecialty Research (AMR), a leading integrated research site organization, announced the appointment of Kari L. Delahunty as the Company’s first Chief Operating Officer.