The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
The long-term status of the trade dispute with China remains unclear, but a 90-day reduction in stratospheric tariffs imposed by the U.S. and China on their respective products provides breathing room for the med-tech companies predicting the hardest hit from the original levels.
Precision medicine holds exciting promise for the medical device industry as it offers a range of solutions within diagnostics, digital devices and imaging, which could transform patient care, delegates heard at the LSX World Congress in London. However, there are a range of challenges ahead, including the population of clinical data, getting past the inertia of physicians and making it easier to run clinical studies.
On Dec. 1, a judge in the U.S. District Court for the District of Delaware granted Natera Inc. a permanent injunction in its patent infringement suit against Archerdx Inc. and its former parent company, Invitae Corp., adding another block to the intellectual property wall of protection around the market dominance of Signatera, Natera’s molecular residual disease (MRD) assay.
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 success of new year’s resolutions for 2023 won’t be known for months to come, but from the vantage point of December, it is easy to see that many large med-tech companies resolved to shed excess weight in 2022 – and did so in dramatic fashion. Some big-name players decided that they would be more agile, and better rewarded by shareholders, with a trimmer portfolio, while others saw value in setting internal operating units free as new companies. As part of our year in review, BioWorld looks at the big deals, the new companies and the impact of all these actions on 2023.
General Electric Co. reported that it was dividing the company into three “well capitalized investment-grade companies with seasoned leadership teams.” The division of the huge conglomerate will start with the tax-free spin-off of GE Healthcare Ltd. in early 2023 and the renewable energy and power business in 2024 leaving the legacy GE as an aviation-focused enterprise. The company will take a one-time hit of $2 billion in connection with the split up.
Diagnostics powerhouse Danaher Corp. has agreed to buy Aldevron LLC, a privately held biotech company that supplies a key ingredient for COVID-19 vaccines, from EQT VIII Fund for $9.6 billion in cash. Based in Fargo, N.D., with additional operations in Madison, Wis., Aldevron makes high-quality plasmid DNA, mRNA and recombinant proteins used in vaccines, gene and cell therapy, gene editing and diagnostic applications.