Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alimera, Cognition, Erydel, Fapon, GSK, Pfizer, PTC, Sage, Seagen, Viiv, Vir.
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
Alivecor Inc. has nudged the U.S. International Trade Commission (ITC) into issuing a limited exclusion order for products by Apple Inc. that are said to violate patents held by Alivecor, but there is one more stage gate to go for Alivecor. The ITC order notes that the exclusion won’t go into force until resolution of an inter partes review (IPR) involving the two firms, a process that could devour as much as a year and a half before a resolution is available.
Looking to turn around the decline of clinical trials within its borders, the U.K. government appointed James O’Shaughnessy, a former health minister, board member of Health Data Research UK and a senior partner at Newmarket Strategy, to conduct an independent review of the country’s commercial clinical trial landscape.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapidai, Spectrum Solutions.
The U.S. FDA recently proposed a modest overhaul of the rules pertaining to radiological products and other categories of products in an effort to eliminate duplicative or obsolete rules, such as a requirement for triplicate reports for variances in system performance.
More than two months after a voluntary recall by Zimmer Biomet Holdings Inc. (ZBio), the U.K. Medicines and Healthcare products Agency (MHRA) issued an alert confirming the U.K. National Joint Registry has identified that there are higher revision rates for certain of the company’s total knee replacement prostheses, as compared to all other knee replacements in the registry.
The U.S. Federal Trade Commission (FTC) released its annual premerger notification report, this one for fiscal year 2021, during which more than 3,400 transactions were reported under the Hart-Scott-Rodino Act (HRS Act). Roughly 17% of these were valued at more than $1 billion, but the FTC is facing bad publicity with the resignation of the sole Republican member of the commission, Christine Wilson, who charged FTC chairwoman Lina Khan with abuse of power.
Now that the U.S. FDA has granted accelerated approval for Biogen Inc./Eisai Co. Ltd.’s early Alzheimer’s drug, Leqembi (lecanemab), the Centers for Medicare & Medicaid Services (CMS) is being pressured to rethink its coverage of amyloid-targeting monoclonal antibodies.
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