Continuing its aggressive buying spree, Bruker Corp. entered into a definitive share purchase agreement with Tecfin S.à r.l. to acquire molecular diagnostics (MDx) company Elitechgroup SAS for €870 million (US$943.5 million), excluding the Elitech clinical chemistry business. The deal is expected to close in the second quarter of 2024 and will be funded with a mix of cash on hand and debt financing.
More than a year and a half after the U.S. FTC launched its investigation into how pharmacy benefit manager (PBM) practices and consolidation impact patients’ ability to access and afford their prescription drugs, the six biggest PBMs in the country have yet to fully comply with the agency’s June 2022 order to provide data and documents pertaining to certain business practices.
Allecra Therapeutics GmbH secured U.S. FDA approval for its beta-lactam/beta-lactamase inhibitor combination, Exblifep (cefepime/enmetazobactam), in complicated urinary tract infections, including pyelonephritis, in patients 18 years and older.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
To understand the focus of startup Insamo Inc., one need look no further than its name, which co-founder and CEO Timothy Craven described as “portmanteau of ‘internally satisfied molecules,’” highlighting its efforts to create orally administered and membrane-permeable cyclic peptides across a range of disease areas.
In the end, Minerva Neurosciences Inc. NDA submission wasn’t able to overcome the U.S. FDA’s concerns regarding data for dual 5-HT2A/sigma 2 antagonist roluperidone. The agency issued a complete response letter (CRL) for the application, which had been seeking approval as the first treatment specifically targeting negative symptoms of schizophrenia.
The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.
The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is much broader than merely evolutionary software and iterative device designs.
Woven Orthopedic Technologies LLC secured a second U.S. FDA 510(k) clearance for the use of its Ogmend implant enhancement system in spine surgery. The approval is for the large size Ogmend sleeve which is compatible with pedicle screws up to 10.5 mm and will give surgeons a tool to be able to easily secure stable fixation between the screw and bone during orthopedic surgery.
Alamar Biosciences Inc.’s substantially oversubscribed series C pushed the company’s total funds raised to $250 million. The company closed the first $100 million on Feb. 26 and expects to close an additional $28 million within 30 days. The target for the series C was $100 million. The funds will be used to drive market adoption of its Argo HT system and nucleic acid linked immune-sandwich assay sequencing (NULISAseq) inflammation panel 250 for deep profiling of immune response.
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