Bethlehem, Pa.-based B. Braun Interventional Systems Inc., an affiliate of B. Braun Medical Inc., and Burlington, Mass.-based Infraredx Inc., a Nipro company, have teamed up to conduct an IDE clinical trial for B. Braun’s Sequent Please Rex drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter, which received FDA breakthrough status in late 2019. The collaboration furthers long-term global cooperation between the B. Braun group of companies and Osaka, Japan-based Nipro Corp. to advance coronary artery disease management.
Baltimore-based Delfi Diagnostics Inc. said it has commenced enrollment for a 1,700-patient, nationwide, prospective study and plans to commercialize an initial test in lung cancer before expanding into other cancer types. The Delfi lung cancer screening test, which combines machine learning algorithms and genome-wide cell-free DNA fragmentation profiles, has received breakthrough device designation from the FDA.
San Francisco-based Komodo Health Inc. is partnering with Janssen Research and Development LLC, of Raritan, N.J., to accelerate clinical development using real-world data and artificial intelligence (AI) software. The collaboration aims to optimize feasibility, site selection and patient recruitment for clinical trials, ultimately driving higher throughput for trials and speeding life-saving therapies to patients.
Merck & Co. Inc., of Kenilworth, N.J., and Alydia Health Inc., of Menlo Park, Calif., have entered a definitive agreement pursuant to which, after the intended Merck spinoff of Organon & Co., Organon will acquire Alydia Health, a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage or abnormal postpartum uterine bleeding. The transaction is expected to close after Organon has spun off from Merck as a standalone publicly traded company. Organon has agreed to acquire Alydia for up to $240 million total consideration, including $215 million upfront plus a $25 million contingent milestone payment. About $50 million of the upfront payment will be paid prior to the spinoff of Organon; $165 million will be paid by Organon upon the close of the acquisition, and the remainder will be paid by Organon upon achievement of the milestone.
Austin-based Natera Inc., a provider of noninvasive genetic testing and analysis of cell-free DNA, and Tesis Labs LLC, a Phoenix-based multi-region lab services provider with labs in Arizona, Colorado and Texas, have forged a strategic partnership to improve access to prenatal genetic testing. The collaboration will allow Tesis to broaden its portfolio of genetic testing offerings and participation the fast-growing screening market for over 4 million pregnancies in the U.S., according to the companies.
Oxford Biodynamics plc (OBD), of Oxford, U.K., and Agilent Technologies Inc., of Santa Clara, Calif., have signed a supply and resale agreement for the manufacture and sale of OBD’s new Episwitch Explore Array Kit. Under the terms of the agreement, Agilent will supply a custom-made Sureprint G3 CGH Microarray for the kit, incorporating OBD’s proprietary 3D genome probes. OBD has exclusive rights for supply and distribution of the kit.
Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. said it has completed its previously announced sale of Takeda Consumer Healthcare Co. Ltd. (TCHC) to Tokyo-based Oscar A-Co KK, a company controlled by funds managed by Blackstone Group Inc. and its affiliates, for a total of ¥242 billion (US$2.19 billion) Following the transfer of shares, TCHC will be excluded from the scope of consolidation of Takeda and operates as Alinamin Pharmaceuticals Co. Ltd.
Chicago-based Tempus Labs Inc. reported the launch of Tempus IC Home Collection, a COVID-19 test with unsupervised self-collection at home. Physicians can now order the Tempus IC Home Collection test for eligible patients and have the collection kits shipped to their homes. Tempus received FDA emergency use authorization for the Tempus Nasal Sample Collection Kit and IC SARS-CoV-2 PCR test.
Chicago-based Typenex Medical LLC said it was awarded a three-year group purchasing agreement for capital equipment and manual microbiology with Charlotte, N.C.-based Premier Inc. Effective May 1, 2021, the agreement allows Premier members to access Typenex’s full vein care portfolio, including the Fibernex Fn II laser system, Fibernex laser fibers, Precision Generator and Procurve V applicator at prenegotiated terms and pricing.