Vancouver, British Columbia-based Abcellera Biologics Inc. reported the acquisition of the Orthomab bispecific platform from Chapel Hill, N.C.-based Dualogics LLC. Orthomab is a clinically validated platform that uses computational and experimental protein engineering methods to create IgG-like bispecific antibodies from any two antibody sequences. By integrating Orthomab into its existing technology stack, Abcellera provides the industry with a solution for generating tailored, stable and developable bispecific antibodies that meet the needs of the biologics market. Abcellera acquires full rights to the Orthomab platform and Dualogics retains rights to develop existing internal assets and to complete existing partnership programs. Tim Jacobs, who led multiple bispecific antibody programs as CTO of Dualogics, joined Abcellera’s team in early August.
Leverkusen, Germany-based Bayer AG said it has reached agreements with plaintiff law firms to resolve approximately 90% of the nearly 39,000 total filed and unfiled U.S. Essure claims involving women who allege device-related injuries. The settlements include all of the jurisdictions with significant volumes of Essure cases, including the state of California Joint Council Coordinated Proceedings (JCCP) and Federal District Court for the Eastern District of Pennsylvania (EDPA). The company will pay approximately $1.6 billion to resolve these claims, including an allowance for outstanding claims, and is in resolution discussions with counsel for the remaining plaintiffs. Settling claimants will be required to dismiss their cases or not file. There is no admission of wrongdoing or liability by Bayer in the settlement agreements. The other terms of the settlement agreements are confidential. These U.S. settlements have no impact on pending litigation in other countries, as Bayer’s decision to resolve these cases is based significantly upon factors that are specific to the U.S. legal system.
Mayaguez, Puerto Rico-based Cdi Laboratories Inc. reported the addition of its SARS-CoV-2 (COVID-19) assay platform. The assays use Cdi's Virscan service which can detect antibodies to 1,345 individual viral strains representing species from 76 viral genera. This is coupled with Cdi's 2 in 1 SARS-CoV-2 antigen microarray which contains overlapping SARS-CoV-2 peptides as well as full-length proteins. This will allow researchers, therapeutic developers, and vaccine developers, to analyze human serum for all known viruses as well as epitope level data on COVID-19 antibodies.
Greiner Bio-One North America, Inc., of Monroe, N.C., and Essex Junction, Vt.-based Haematologic Technologies Inc. (HTI) reported a collaboration to provide end-to-end development and custom manufacturing of blood collection tubes for IVD and clinical diagnostic device developers. The collaboration will marry HTI's capability of producing pilot scale and small-to-medium sized batches of customized blood collection tubes with Greiner's custom blood collection tube manufacturing services, which excels at GMP-level manufacturing of high-volume batches. Through this collaboration, Greiner Bio-One and HTI will offer IVD and clinical diagnostic device developers a vertically integrated solution spanning from early development to large scale production of their custom collection tubes.
Saint Laurent, Quebec-based Intelgenx Corp. has entered a feasibility agreement with Berlin-based Atai Life Sciences AG, a global biotech developing psychedelic and non-psychedelic compounds for a variety of mental health indications, for the development of novel formulations of pharmaceutical-grade psychedelics based on Intelgenx's polymeric film technologies. Intelgenx will conduct pre-development and formulation development work to provide a product prototype to Atai for further clinical investigation. The agreement also contemplates a term sheet upon which the parties will enter into an exclusive, royalty-bearing license to commercialize the Product worldwide.
Malvern, Pa.-based Lifescan Inc. reported findings of a blind survey showing that health care professionals (HCPs) that work with people with type 1 and type 2 diabetes and use blood glucose meter data to inform treatment decisions had a strong preference for self-monitoring meters providing additional insights, messages and guidance. The online survey, managed by market research firm Ipsos, engaged 353 HCPs from the U.S., Canada, France, Germany and Italy. In all countries, across all participating HCP disciplines, Lifescan’s Onetouch Vero Reflect meter was ranked significantly higher on clinical utility for all guideline questions (70-84%, p<0.05), compared with three other meters. The findings were published online Aug. 10 in Journal of Diabetes Science and Technology.
Dublin-based Medtronic plc reported the start of a prospective, multicenter, global, postmarket study of its Interstim Micro system for sacral neuromodulation therapy. The Evaluation of Interstim Micro System Performance and Safety (ELITE) study will enroll 160 subjects with overactive bladder, fecal incontinence and nonobstructive urinary retention across 40 sites in the U.S., Europe, Australia and Canada. Objectives include patient-reported outcomes, disease-specific quality of life questionnaires and symptom diaries. Patients will be followed for two years.
Myomo Inc., a Cambridge, Mass.-based company focused on wearable medical robotics for neurological disorders and upper-limb paralysis, reported the first Australian insurance authorization for its Myopro device.
San Diego-based Nanocellect Biomedical Inc. said it has inked agreements with several key partners to distribute its Wolf Cell Sorter throughout East Asia and Western Europe.
Neurometrix Inc., of Woburn, Mass., said its Quell device will be used in an NIH-funded, multisite, randomized, controlled trial of the efficacy of transcutaneous electric nerve stimulation for chemotherapy-induced peripheral neuropathy (CIPN). The phase II, double-blind, sham-controlled study will enroll a total of 150 patients with CIPN, randomized to an active or sham Quell device for six weeks, with instructions to use the device for five hours each day. The primary outcome measure is baseline to six-week change in CIPN20, a composite measure of symptom experience and functional limitations related to CIPN.
Onconano Medicine Inc., of Southlake, Texas, has been awarded $9.97 million from the Cancer Prevention and Research Institute of Texas to expand the application of its lead product, ONM-100, a novel imaging agent used in intraoperative surgical resection of solid tumors, for imaging metastatic disease. ONM-100 was granted a fast track designation by the U.S. FDA and is currently in phase II clinical trials.
Clinical informatics startup Ovation.io, of Cambridge, Mass., launched pooled testing for COVID-19 to support return to campus and work initiatives. Specifically, the University of Alabama at Birmingham and supporting labs have adopted Ovation’s Lab Operating Software for COVID-19, molecular and genomics testing.
Specialty cancer diagnostics company Precipio Inc., of New Haven, Conn., signed an exclusive global agreement with Ads Biotec Inc., of Omaha, for the sale and distribution its IV-Cell cytogenetics cell culturing media.
San Diego-based Quidel Corp. said that labeling for the U.S. FDA emergency use authorization for its Sofia SARS Antigen test has been amended to include either nasal or nasopharyngeal swabs. Separately, the company said it has completed an investigation regarding a report of false positive results at a testing location in Vermont and found no testing site- or product-related issues with the Sofia 2 instrument or the Sofia SARS Antigen FIA.
Dublin-based Trinity Biotech plc has submitted an emergency use authorization application to the U.S. FDA for its COVID-19 IgG Elisa antibody test. The product demonstrates greater than 98% specificity and in excess of 95% sensitivity in samples of 14 days or more from symptom onset, according to the company.
The University of Nottingham Ningbo China (UNNC) said it will soon introduce the world’s first 1.5 Tesla (T) rotatable, dual-gesture magnetic resonance imaging (MRI) scanner. The technology is a collaboration among UNNC, Ningbo Gaosi Superconducting Technology Co. Ltd., Ningbo Xingaoyi Medical Equipment Co. Ltd., China Academy of Sciences University Ningbo Hwamei Hospital and the First Affiliated Hospital of Zhejiang University School of Medicine, in Hangzhou.
Toronto-based Vitalhub Corp. has acquired Intouch With Health Inc., of Gloucester, U.K., a company focused on patient flow management solutions. Total consideration paid by Vitalhub, after a closing net equity adjustment, was approximately £3,850,000 (US$5,057,313), which is being paid in cash to the vendors of Intouch on closing of the acquisition, save for £577,500, which will be held for the purpose of customary post-closing adjustment and released four months post-closing. In addition, Vitalhub has agreed to certain additional cash payments up to a maximum of £800,000 to the Intouch shareholders pursuant to an earn-out clause triggered on achievement of certain business milestones of Intouch over the next three years.