Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aro, Candel, Inversago, Jasper, Kymera, Lipocine, Mallinckrodt.
With four complete response letters behind it and seven months ahead of its April 2023 PDUFA date, Mallinckrodt plc’s Terlivaz (terlipressin) has been approved by the U.S. FDA for treating hepatorenal syndrome. Terlivaz had a decade-long series of obstacles before getting the long-awaited approval. The vasopressin analogue selective for V1 receptors was approved, in part, on results from the phase III CONFIRM trial of 300 patients, which met its primary endpoint of renal function improvement, avoidance of dialysis and short-term survival (p=0.012).
The Biden administration’s views of mergers and acquisitions have veered sharply from those of the previous administration, but Jonathan Kanter, assistant U.S. attorney general, said recently that there is more to come. Kanter said the Department of Justice (DOJ) and the Federal Trade Commission (FTC) will shortly publish draft guidelines that would place the burden on the parties to these M&A transactions to prove the transaction is not anticompetitive, upending the historical presumption that the plaintiff is liable for demonstrating the anticompetitive nature of the proposed transaction.
Medical device manufacturers have railed against payers’ prior authorization practices for years, but the U.S. Congress seems poised to finally address the issue, at least in the context of Medicare Advantage (MA) plans. The House of Representatives has passed the Improving Seniors’ Timely Access to Care Act of 2021, a development that drew the applause of both the Medical Device Manufacturers Association (MDMA) and the American Society of Radiation Oncology (ASTRO), a clear display of the broad support enjoyed by the legislation.
With the science on aging advancing, it’s time for the U.S. to modernize its regulatory approval path for new longevity treatments, members of a House Science, Space and Technology subcommittee were told Sept. 15.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BVI, CTL Amedica, Edwards Lifesciences, Konica Minolta.
The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and manufacturing activities.
From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, Tasso.
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