A tissue engineered polymer wrap designed to reduce vein graft failure rates in patients on hemodialysis for chronic kidney disease (CKD) has won FDA breakthrough device designation. Developed by Houston-based Venostent Inc., the Selfwrap bioabsorbable perivascular wrap is macroporous material that wraps around blood vessels and acts as a scaffold to ensure veins and arteries work together seamlessly to filter out toxins in the patient’s blood.
Among the latest guidances pouring out from the U.S. FDA are ones addressing development programs for hormone analogues intended to treat advanced prostate cancer and prescription drug importation from Canada.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medalliance, Nanomix.
A rule forcing the FDA and other agencies in the U.S. Department of Health and Human Services (HHS) to evaluate and clean out old regulations will never see the light of day.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Biomind, Clearmind, Cynata, Hyundai, Innocare, Janssen, Merck, Pfizer, Reata, Revive, Roche, Scisparc, Servier.
The U.S. FDA has received a citizen’s petition regarding the use of neuropsychological testing prior to placement of a deep brain stimulation (DBS) device for treatment of Parkinson’s disease. The petitioners, most of whose names were redacted, said that there is no standardized test for this purpose, and thus the patient should have sole discretion of evaluating the meaning of their own tests or the use of these tests should not be seen dispositive of the question of whether to go ahead with placement of a DBS device for Parkinson’s.
A lengthy trial over two generic drug manufacturers’ alleged role in fueling the opioid epidemic in West Virginia came to an end this week when the U.S. affiliate of Teva Pharmaceuticals Ltd. and Allergan, now part of Abbvie Inc., agreed to a settlement totaling more than $161.5 million.
Ignoring congressional sentiment, U.S. Health and Human Services Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health as an independent entity within the NIH.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Lumiradx, Nexus Medical Labs, Rhinostics.
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