BioSpace News Archive

The companies’ antibody-drug conjugate improved progression-free survival with a “trend in improvement” for overall survival in patients with HR-positive, HER2-low or negative breast cancer.

A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.

Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.

Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.

ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.

The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.

Positive topline results from the TROPION-Breast01 phase 3 trial showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival compared to investigator’s choice of chemotherapy in patients with inoperable or metastatic hormone receptor positive, HER2 low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

MicuRx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has granted Qualified Infectious Disease Product and the Fast Track Designation under the Generating Antibiotic Incentives Now Act for contezolid tablet and contezolid acefosamil tablet and intravenous as novel new oxazolidinone antibiotics for the treatment of moderate to severe diabetic foot infection without concomitant osteomyelitis.

Vizient, Inc. today announced 2023’s top performers in clinical quality and supply chain excellence.

Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced that it has submitted applications to the Ministry of Health (MoH) and local Ethics Committee in Turkey to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).