Spero Therapeutics' SPR206, being developed to treat patients with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia or complicated urinary tract infections, was given qualified infectious disease product designation by the FDA. The company intends to launch a safety, tolerability and pharmacokinetic early-stage study of the candidate next year.
The Dual Differential Correction Philosophy & Technique, developed by K2M for its Mesa Platform Technology to treat sagittal imbalances in the spine, has received FDA clearance. The technique corrects a patient's imbalances using rod rigidity and degree of bend, as well as patient-specific rods and rails.
Health Canada has granted Medtronic Canada license to market the MiniMed 670G insulin pump system for patients with type 1 diabetes ages 7 and older. The system, which is expected to be launched in Canada this fall, enables automatic basal insulin delivery adjustment based on real-time needs of users.
More than 35,000 pounds of refrigerated pasta entrees that contain meat and chicken are being recalled by Valley Fine Foods after routine internal testing found they could be contaminated with spoilage organisms. The recalled products were distributed to California, North Carolina, Connecticut, Massachusetts, Maryland and Michigan.
Rigel Pharmaceuticals' marketing application for Tavalisse, or fostamatinib disodium hexahydrate, indicated for the treatment of chronic immune thrombocytopenia, has been accepted by the European Medicines Agency for review. The EMA's advisory group, the Committee for Medicinal Products for Human Use, is expected to announce its opinion in the last quarter of 2019.
Iovance Biotherapeutics intends to enroll a cohort of 80 to 100 patients to its ongoing midstage study of LN-144-01 for melanoma early next year and submit a marketing application to the FDA in the second half of 2020. Initial results from the study demonstrated a 37% objective response rate in patients with advanced melanoma who received a PD-1 inhibitor and a BRAF inhibitor if the disease is BRAF mutation-positive.
A merger deal between scientific research company Spherix and CBM BioPharma will result in CBM receiving 15 million shares of common stock from Spherix. The deal will also grant Spherix access to two experimental drugs, one for acute myeloid leukemia and acute lymphoblastic leukemia and another for pancreatic cancer.
Prime the Pump and Casey's General Store agreed to work together to expand E15 biofuel offering to more than 500 Casey's locations in the next several years. "Since first rolling out E15, we've seen the benefit the biofuel blend offers in terms of value for our customers and a competitive advantage for our business," said Nathaniel Doddridge of Casey's.
Rensselaer Polytechnic Institute President Shirley Ann Jackson was awarded the W.E.B. DuBois Medal by Harvard University's Hutchins Center for African & African American Research for major contributions to African and African-American culture and history. Jackson is a 2016 National Medal of Science winner, served as co-chair of former President Barack Obama's Intelligence Advisory Board and was on the Secretary of Energy Advisory Board.
Chemical biologist Carolyn Bertozzi is bringing together clinicians, engineers and scientists through Stanford University's ChEM-H program and the Chemistry/Biology Interface, a predoctoral program that focuses on ensuring biology and chemistry students learn to communicate with one another. Bertozzi says she wants to see clinicians recruit basic scientists and engineers to patient care teams.