The U.S. Court of Appeals for the Federal Circuit didn’t change a thing in a trio of rulings stemming from Eli Lilly and Co.’s inter partes review challenges of several patents protecting Teva Pharmaceutical Industries Ltd.’s migraine drug, Ajovy (fremanezumab).
As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable.
The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems.
Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder to treat people with atrial fibrillation who are at risk of ischemic stroke about a month earlier than generally expected, given the backlog at the FDA. The dual-closure device closes the left atrial appendage during the procedure, reducing the risk of blood clots immediately and eliminating the need for blood thinners both during the healing process and longer term.
The U.S. FDA said the results of a Section 522 postmarket surveillance study of transvaginal mesh devices by Boston Scientific Corp. suggested similar effectiveness and safety outcomes at 36 months compared to native tissue repair. However, the agency said patients with mesh repair for pelvic organ prolapse (POP) are exposed to additional risks, such as mesh exposure and erosion, and thus the agency is disinclined to allow these devices back onto the market.
The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to drop its national non-coverage policy for pulmonary embolectomy, a procedure for which multiple devices have been cleared or approved by the FDA. Several stakeholders, including more than one med-tech trade association, had requested such a change, and CMS indicated that much more evidence will be needed before it can forge a national coverage policy that would eliminate the impending geographically differentiated patient access.
A change of presidential administrations often brings a significant change in regulatory policy, and the Granston memo did just that shortly after the Trump administration took office in 2017. However, the Department of Justice (DoJ) has dismissed fewer whistleblower (qui tam) lawsuits against the private sector recently, a trend that Jonathan Phillips of Gibson Dunn said was evident before the Biden administration took over.
Medcura Inc. has secured $7.4 million in series A equity financing to grow its line of hemostatic and wound treatment products. Part of the proceeds from the investment will go toward further developing the company’s lead surgical candidate, Lifegel, and advancing it to clinical trials.
The FDA applied a class I tag to the recall of Dose IQ software used in infusion pumps made by Baxter Healthcare because of a defect in the software, although there have been no reported injuries or fatalities. The defect is blamed for creating mismatches between the drug library and the drug loaded into the infusion pump, which can lead to potentially deadly over- or under-infusion of the medication.
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