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.
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024.
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
The COVID-19 pandemic might be officially over, but future variants could still pose a threat, and serious health consequences of the causative virus continue to arise, a fact that has prompted the U.S. government to offer Regeneron Pharmaceuticals Inc. about $326 million to develop and manufacture a next-generation COVID-19 monoclonal antibody therapy.
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