Babson Diagnostics Inc. has line of sight for the commercial launch of its Betterway blood testing ecosystem, which is a less invasive way of taking blood and requires only one-tenth of the sample volume of venipuncture without sacrificing quality or accuracy. The company said that once the collection device developed in partnership with Becton Dickinson & Co. (BD) is cleared by the U.S. FDA, Betterway will be launched in Texas, where it already has established partnerships with retailers and where its commercial lab is up and running. In addition, Babson has fully validated a broad set of miniaturized assays that are ready for commercial processing in its CLIA-certified, CAP accredited laboratory.
Theken Companies LLC reported the acquisition of Visionair Solutions Inc. from the Cleveland Clinic, a deal that adds pulmonary therapy to its broad portfolio with Visionair’s 3D platform for the creation of silicon stents for central airway obstructions (CAOs). Terms of the transaction, which has officially closed, were not disclosed.
Two papers published in Nature on Aug. 23, 2023, describe brain computer interfaces (BCI) with unprecedented capabilities for decoding brain activity into sentences, translating at speeds around half that of normal speech, and with vocabularies exceeding 1,000 words.
The U.S. FTC has recalibrated its challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc while one of the biggest trade groups has voiced its concerns about the government’s role in the deal. An amicus brief from the Biotechnology Innovation Organization (BIO), along with the Illinois Manufacturers Association, the Chicagoland Chamber of Commerce and the Illinois Biotechnology Innovation Organization, calls the FTC expansion into such deals overreach that chills pro-competitive biopharma mergers.
Abcam plc closed out a three-month whirlwind of activity on August 28 with an agreement to sell the medical consumables company to Danaher Corp. for a purchase price of $24 per share in cash, a 2.7% premium over the previous closing price, and assumption of approximately $200 million in debt. The deal, which has an enterprise value of $5.7 billion, is expected to close in mid-2024.
The U.S. FDA has given Aquedeon Medical Inc. the green light to conduct an IDE clinical trial of its Duett vascular graft system. The device is designed to improve outcomes in surgical thoracic aortic procedures by simplifying treatment of target vessels and reducing overall procedure time.
Cochlear Ltd. and Sensorion SA have published encouraging results on the combination of a molecule with a cochlear implant. Their proof-of-concept phase 2a study involved the combination of an orphan drug recognized in both Europe and the U.S. with cutting edge hearing aid implants to enhance the auditory capabilities of hearing aid users.
One of the key advances in regenerative medicine has been the engraftment of external epithelial stem cells to supplement or replace damaged native cells. However, the difficulty in engrafting internal tissues has hindered the long-term rescue of diseased internal epithelia, such as those in the respiratory airways.
Biosimilars continue to pose cheaper alternatives to their established, blockbuster counterparts. The U.S. FDA has approved Tyruko (natalizumab-sztn) from Sandoz Inc., the generics business of Novartis AG. It is the first approved biosimilar to Biogen Inc.’s blockbuster Tysabri (natalizumab), an injectable monoclonal antibody for treating adults with relapsing forms of multiple sclerosis (MS).
The U.S. Department of Justice (DOJ) has been aggressively pursuing fraud perpetrated on the American public in connection with the COVID-19 pandemic, but the formal end of the U.S. public health emergency might seem to suggest that these efforts would be winding down. Nonetheless, deputy attorney general Lisa Monaco has announced that DOJ will open two new strike force offices under the agency’s COVID fraud operations, making clear that the agency is still intent on chasing down fraudsters across the U.S.
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