The U.S. federal government’s crackdown on companies in the health care space shows no signs of slowing down as indicated by an announcement by the Department of Justice (DOJ) that it has achieved a settlement with Opko Health Inc. and Bioreference Health LLC regarding allegations of induced referrals.
Reliance Medical Systems LLC agreed to pay $1 million to address allegations of violation of the Anti-Kickback Statute (AKS), but the company has responded to that outcome with a blistering riposte.
A “clean” user fee bill with no congressionally added policy riders. It’s been a biopharma and med-tech dream for years. But now that U.S. Sen. Richard Burr (R-N.C.) has introduced such a bill, it could prove a nightmare, given competing legislation and the tight timetable for reauthorizing the user fee programs before the clock winds down on the current agreements Sept. 30 when fiscal 2022 ends.
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Radialis, Werfen.
If anti-aging drugs are to become widely available and adopted, especially in the U.S., they have some serious hurdles to overcome. And those hurdles aren’t all in the lab or clinic. With classes of anti-aging drugs already in the pipeline, “the biggest hurdle is FDA approval. Then reimbursement,” said George Kuchel, a professor and director of the UConn Center on Aging at the University of Connecticut. Read the final installment of BioWorld’s multipart series on extending the human lifespan.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cstone, Escend, Gilead, Moderna, Neurophth, Neximmune, Novartis, Omega, Polpharma, Prescient.
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
Illumina Inc., of San Diego, is struggling to complete the regulatory side of its acquisition of Grail Inc., of Menlo Park, Calif., thanks in part to the U.S. Federal Trade Commission’s (FTCs) ongoing review of the transaction. However, Illumina is also facing stiff winds in Europe where the General Court of the European Union rejected the company’s bid to push the deal through despite the opposition of the European Commission (EC).
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
RSS
