PharmaCyte Biotech | September 02, 2020
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “Submitting this IND is the most important milestone the Company has met thus far in the clinical development of our leading product candidate. That’s our therapy to combat what is truly a global unmet medical need for those patients with LAPC whose tumors no longer respond to the first line treatments of either Abraxane® plus gemcitabine or FOLFIRINOX. “Now that the IND has been submitted, we must wait a minimum of 30 calendar days before initiating our clinical trial. During this time, the FDA has an opportunity to review the IND to ensure that it’s complete and that the planned clinical trial research patients will not be subject to unreasonable risk. It also gives the FDA time to ask for more information and clarification about the information submitted.
Ajinomoto Bio-Pharma Services | May 05, 2020
Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce it has entered into a manufacturing services agreement with CytoDyn Inc., a late stage biotechnology company, for the supply of the investigational new drug, leronlimab (PRO 140), which is currently being used in clinical trial protocols for Mild-to-Moderately Ill and Severely Ill COVID-19 patients.Aji Bio-Pharma provides high quality drug product aseptic fill finish services for CytoDyn. Leronlimab, a novel CCR5 antagonist with the potential for multiple therapeutic indications, has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by the U.S. Federal Drug Administration (FDA) as part of Phase 1, Phase 2 and Phase 2b/3 clinical trials. CytoDyn is currently enrolling patients in two placebo-controlled randomized clinical trials for Phase 2 and Phase 2b/3."We are very excited to support CytoDyn's efforts to utilize this promising antibody therapeutic in the fight against COVID-19," said Kristin DeFife, Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services.
Halo Labs | June 29, 2020
Halo Labs, a life science instrumentation company developing tools for biologics researchers, today announced it has launched its latest aggregate and particle identification system, called Aura™.Aura is the next generation of the Horizon®, Halo Labs' popular Backgrounded Membrane Imaging (BMI) platform. With as little as 5 µL and a linear range of over 3x106 particles/mL, BMI can count, size, and image aggregates and particles in the subvisible range (>1 μm). The Aura instrument now adds protein/non-protein identification using Fluorescence Membrane Microscopy (FMM) and is the only subvisible particle analyzer on the market to have 100% sample efficiency. An optional second fluorescence channel gives customers the ability to also detect lipids and other drug and process-specific particles.