Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ultrasight.
Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
The U.S. FDA has issued a draft guidance for devices intended to address opioid use disorder (OUD), a problem with a massive public health footprint that has defied the efforts of public health programs. The draft guidance highlights some of the difficulties in executing pivotal studies for these devices, but the FDA’s July 27 press omits any mention of a 2018 innovation challenge for this category of devices, a programmatic effort that seems to have yielded little in the way of tangible results.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Anova, Denovo, Incannex, Innocare, Inozyme, Myopax, Octapharma, Opthea, Pint.
Continuing its efforts to reduce prescription drug prices in the U.S., the Senate Finance Committee turned up the heat on pharmacy benefit managers (PBMs), voting overwhelmingly, 26-1, to send the bipartisan Modernizing and Ensuring PBM Accountability (MEPA) Act to the full Senate.
Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
Krystal Biotech Inc. has received FDA acceptance of its IND application for lead oncology drug candidate KB-707 for the treatment of locally advanced or metastatic solid tumor malignancies. KB-707 is a modified herpes simplex virus 1 (HSV-1) vector designed to deliver genes encoding both human IL-12 and IL-2 to the tumor microenvironment and promote systemic immune-mediated tumor clearance.
Cessation Therapeutics Inc. has obtained IND clearance from the FDA to initiate a first-in-human trial of CSX-1004 for the prevention of fentanyl overdose. The trial in healthy volunteers is expected to begin next month.
Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.
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