Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonalive, Evoendo, Novacyt, Oncimmune.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Confluent, Flagship Biosciences, Lunaphore, Meenta, Nextgen Healthcare, Paige.AI, Sectra, Verato, Virtual Control.
As the Biden administration continues to play musical chairs with key U.S. federal health leadership positions, its latest move is naming Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisers on Science and Technology.
Most of the better-known targets of prosecution under the U.S. False Claims Act (FCA) are drug and device manufacturers, but the Department of Justice (DOJ) seems to have opened a new front in the war on Medicare fraud.
In a move that stunned and dismayed analysts and investors, Masimo Corp. announced a definitive agreement to acquire Sound United LLC Tuesday evening for $1.025 billion. Masimo’s stock (NASDAQ:MASI) plunged on the news of its intended purchase of the high-performance consumer audio products company, plummeting 39% from $228.84 at Tuesday’s close to $139.60 at Wednesday’s opening bell. Volatility led the Nasdaq to suspend trading in the stock for four minutes before 10 am. The stock recovered slightly during the day to close Wednesday at $147.00.
The selection of Robert Califf to run the U.S. FDA might seem like a safe move on the part of the White House, but some believe his prior experience at the FDA does not necessarily suggest an acceptance of the regulatory status quo. Peter Pitts, president of the Center for Medicine in the Public Interest, told BioWorld that while Califf is “not a flashy pick,” Califf possesses a very keen understanding of the need to modernize the FDA’s practice of regulatory science, which should be a welcome bit of news for makers of drugs and devices.
Collplant Biotechnologies Ltd. has signed a collaboration agreement with 3D bioprinting company Cellink AB for future commercial production of regenerative breast implants. Rehovot, Israel-based Collplant has developed prototypes of 3D bioprinted implants and is evaluating them in preclinical studies. The regenerative implants are designed to degrade over time and be replaced by new, naturally grown breast tissue. The technology aims to overcome the challenges of existing breast procedures that use silicone implants or autologous fat tissue transfer.