CAJICA, Colombia – A cooler box with 70 vials allegedly filled with counterfeit COVID-19 vaccines seized from a Chinese couple in Colombia’s El Dorado International Airport on Feb. 17 underscored the growing challenges facing pharmaceutical companies, law enforcement authorities and health care regulators around the world. Patient safety, company liability, and the security of distribution channels have all been areas of growing concern. Read More
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius). Read More
News of Vaccinex Inc. signing two multitarget deals with undisclosed "prominent pharmaceutical companies" sent company shares (NASDAQ:VCNX) up 70% to $4.88 on Feb. 19, even as financial terms of the deal went undisclosed. The collaborations will focus on using the company's ActivMAb antibody discovery and novel viral display platform to develop candidates against complex antigens such as G protein-coupled receptors and ion channels, the company said. Read More
HONG KONG – Beijing-based Beigene Ltd. struck its second deal outside China this year, signing an option and license agreement with Boston Immune Technologies & Therapeutics Inc. (BITT) for the latter’s tumor necrosis factor receptor 2 (TNFR2) antagonist antibodies. Beigene will exclusively develop, manufacture and commercialize BITT’s TNFR2 antagonist antibodies in Asia, excepting Japan, Australia and New Zealand. Read More
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Under the terms, Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in the region in exchange for a $10 million up- front payment and as much as $112 million in development and commercial milestones, plus low double-digit royalties on net product sales. Read More
As developers continue their race in the anti-CD47 space, Gilead Sciences Inc. remains high profile with magrolimab, which has reached phase III development for myelodysplastic syndromes. Meanwhile, Alx Oncology Inc., of Burlingame, Calif., is emerging with potentially the first drug targeting the CD47-SIRPa axis to treat solid tumors as well as hematologic malignancies. Read More
BioWorld looks at translational medicine, including: Classifying variants of unknown significance; Platelets release antigenic DNA in lupus; Intracranial samples give glimpse into stroke response. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Bridgebio, Insmed, Pharvaris, Perception, Woolsey. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Algernon, AMR, Cleveland Biolabs, Cytocom, Evolus, Fordoz, Jaguar, Life Biosciences, Lipomedix, Medytox, Metabolon, Novavax, Precision Biosciences, Sensorion, SXT, TFF. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dr. Reddy’s, Dynavax, Immunicum, Immunocore, Incyte, Janssen-Cilag, Junshi, RDIF, Travere. Read More
