A peptide produced by the skin bacterium Staphylococcus caprae, which does not lead to the serious infections that can result from its cousin S. aureus, was able to inhibit S. aureus colonization by inhibiting quorum sensing. Different bacterial species interact with each other in the human microbiome, and researchers from the University of Colorado at Denver hypothesized that benign Staphylococcus strains, which have received less attention than S. aureus because they do not lead to severe disease, might be able to influence the behavior of S. aureus. Read More
AIT Therapeutics Inc., of New York, disclosed the publication of its phase II, double-blind, randomized controlled trial for treatment of infants with moderately severe bronchiolitis. Read More
Pfizer Inc., of New York, said it has negotiated exclusive rights to develop, distribute and commercialize Cresemba (isavuconazole) from Basilea Pharmaceutica Ltd., of Basel, Switzerland. Read More
Prometic Life Sciences Inc., of Laval, Quebec, said it closed the C$100 million (US$80 million) line of credit previously entered into with Structured Alpha LP, an affiliate of Peter J. Thomson's investment firm, Thomvest Asset Management Inc. Read More
DUBLIN – Zelluna Immunotherapy AS is the latest contender to throw its hat into the immuno-oncology ring, but the Oslo, Norway-based startup can draw on several decades' worth of clinical research in its effort to build a pipeline of cell and biologic therapies based on proprietary T-cell receptors (TCRs) against important tumor antigens. Read More
Semma Therapeutics Inc. has raised $114 million in a series B financing aimed at carrying its stem cell-derived beta cells, a potential therapy for people living with type 1 diabetes, through proof-of-concept studies. The company is preparing to file an investigational new drug (IND) application for the program while also exploring additional applications for its technologies. Read More
Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare & Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx. Read More
Indivior plc turned the page on treatment for severe opioid use disorder (OUD), gaining FDA approval of Sublocade (buprenorphine extended-release, previously RBP-6000) subcutaneous injection as the first once-monthly injectable buprenorphine formulation to treat moderate to severe OUD in patients who initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days. Regulated as a schedule III controlled substance, Sublocade is intended to be administered by providers as part of a treatment program that includes counseling and psychosocial support. Read More
The FDA has given Mylan NV the go-ahead for its Ogivri (trastuzumab-dkst), a biosimilar to Roche AG's blockbuster breast cancer therapy Herceptin (trastuzumab), for patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene. Read More
