Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcoma, Renovia, Zsquare.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Biogen, Chinook, Coherus, Junshi, Inflarx, Kazia, Olix, Pyramid, Roche, Sensorion, Takeda, Titan, Turnstone.
The U.S. Federal Trade Commission (FTC) affirmed its proposed order to force Intersect ENT Inc., of Menlo Park, Calif., to divest itself of Fiagon AG before Dublin-based Medtronic plc., can complete its acquisition of Intersect. The announcement comes as no surprise, but serves as a reminder that the FTC is standing by previous threats to tightly control the mergers and acquisitions market in the U.S., a policy stance that has been duplicated in the European Union.
The U.S. FDA’s efforts to improve medical device quality includes a recent draft guidance that pertains to the pilot version of a voluntary improvement program, but stakeholders see a number of critical issues with the draft. A coalition of device makers said this pilot program should include disclosure guardrails that parallel similar guardrails provided for medical device reports (MDRs), a provision related to discovery during product liability litigation that is seen as critical if device makers are to take part in the voluntary improvement pilot.
While the U.S. Congress struggles to patch together statutory restraints on prescription drug prices, the U.S. Patent and Trademark Office (USPTO), with the FDA’s help, is taking steps to cut back the patent thickets some drug companies are using to ward off the competition that would bring those prices down.
Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the court has declined to hear the American Axle case, leaving many observers despairing of any chance of restoring a decent patent system for personalized medicine, companion diagnostics and even the use of artificial intelligence in drug development.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Aneurotech, Dyne, Hyloris, Novavax, Pfizer, Sanofi, Xbrane.
Lung cancer claims more lives each year than any other cancer, making early and accurate diagnosis crucial to improving survival rates. To that end, the U.S. FDA has cleared the integration of Intuitive Surgical Inc.’s Ion endoluminal system and Siemens Healthineers AG’s Cios Spin mobile imaging cone-beam CT imaging technology to enhance robotic lung biopsies.
RSS
