Danco Laboratories LLC’s abortion pill, Mifeprex (mifepristone), and a generic will remain on the U.S. market with tighter restrictions while a challenge to the drug’s 2000 accelerated approval and the FDA’s subsequent loosening of prescribing requirements plays out on appeal. That is unless the Supreme Court says otherwise.
The U.S. FDA has granted de novo authorization to Moximed Inc. for its Misha knee system, a first-of-its-kind implantable shock absorber for people suffering from osteoarthritis (OA) of the knee. The device is intended to relieve pain and improve daily function in patients ineligible for, or not ready to undergo, joint replacement.
As an April 15 deadline looms, the U.S. Court of Appeals for the Fifth Circuit is being asked to intervene immediately to keep mifepristone on the U.S. market as an abortion option while legal challenges continue to play out in court.
Getinge AB received U.S. FDA premarket approval (PMA) for its Icast covered stent system, which has been used by clinicians for 20 years under the brand name Advanta V12. Icast is designed to treat patients with iliac arterial occlusive disease, a type of peripheral arterial disease where atherosclerosis narrows and blocks peripheral arteries.
Becton, Dickinson and Co. (BD) tackled the persistent issue of missed vessels for intravenous (IV) placement with the goal of enabling hospitalized patients to have a ‘one-stick stay.’ The Prevue II system uses the BD Cue needle tracking-enabled system, which offers a high-quality ultrasound image of the needle trajectory in conjunction with real-time needle depth markers.
Pear Therapeutics Inc. filed for bankruptcy protection under chapter 11 to buy time to sell its assets. The company was the first-to-market for prescription digital therapies, with three PDTs gaining regulatory nods from the FDA: Reset for substance use disorder, Reset-O for opioid use disorder and Somryst for insomnia. Reset-A received breakthrough device designation in 2021. The Reset therapies are approved for use in conjunction with medication therapy or other outpatient therapy for substance use.
Hundreds of executives from biopharma companies are signing onto an April 10 letter decrying a U.S. district judge’s decision last week to stay the FDA approval of mifepristone, which is used in more than half of all abortions in the U.S.
Batteries used in medical devices don’t always perform as expected, but Abbott Laboratories has issued an advisory to users of its Freestyle glucose monitoring systems in connection with overheating of the batteries used in the device’s readers, a problem the company said is not related to the batteries themselves. Abbott Park, Ill.-based Abbott has received reports of battery swelling and overheating in the reader unit, but advised users that use of non-Abbott charging cables seems to drive the risk of such episodes, urging users to stick with the USB charging cables that came with the readers.
The long-running Makena saga came to a close April 6 with the U.S. FDA announcing its decision to immediately withdraw approval of the drug and its generics – the only drugs indicated in the U.S. to reduce the risk of preterm birth.
The Biden administration has released the National Cancer Plan, a framework that expands and builds on the Cancer Moonshot program which came into being in 2016. The National Cancer Plan includes a strategies section that calls for development of new methods for detecting cancer and new imaging technologies for early cancer detection, just two provisions that would seem to portend good times ahead for companies that manufacture these products.
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