BioSpace News Archive

As the pandemic has evolved rapidly, so too have the FDA’s views and requirements on what pre-clinical and non-clinical data sets will be necessary to support initiation of a first in human clinical trial for COVID-19. In written responses to the questions provided by the Company, the FDA addressed PharmaDrug’s questions related to manufacturing, safety/toxicology, pre-clinical efficacy studies, clinical trial design, and rationale necessary to support subsequent human clinical trials.

IDBS, a Danaher (NYSE:DHR) operating company, announced Polar Insight, bringing new advanced data analytics and visualization tools to the Polar BioPharma Lifecycle Management (BPLM) platform.

As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic.

Canon Medical Systems Corporation and Resoundant, Inc. (Rochester, MN, USA) have signed a licensing agreement for the purpose of incorporating the advanced Magnetic Resonance Elastography (MRE), developed by Resoundant on the Canon MRI platforms.

StatLab Medical Products (StatLab), a leading developer and manufacturer of diagnostic supplies and equipment for the anatomic pathology market, today announced the appointment of industry veteran Kim Kelderman to the StatLab Board of Directors.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, announced the opening of a new clinical study in collaboration with Dr. Duane Mitchell at the University of Florida.

Approximately $211.48 million in aggregate principal amount of Any and All Notes were validly tendered and not validly withdrawn prior to 5:00 p.m., New York City time, on November 29, 2021 and will be accepted for purchase on the Early Settlement Date.

Merck, known as MSD outside the United States and Canada, announced that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the first quarter of 2022.

Avid Bioservices, Inc. (NASDAQ:CDMO), today announced that it will report financial results for the second quarter of fiscal year 2022 on December 7, 2021 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time).

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that Jude Onyia, Ph.D., has joined the company’s executive management team as Chief Scientific Officer.