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.
Following a comment-and-review process waylaid by the COVID-19 pandemic, the U.S. FTC is finalizing its revised guides on the use of endorsements and testimonials in advertising.
Rather than waiting on the courts to sort out the 340B dispute between the U.S. Department of Health and Human Services (HHS) and prescription drug manufacturers, a group of senators is looking for bipartisan legislative solutions that would infuse the drug discount program with more accountability, certainty, oversight and transparency.
In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev.
As new and ongoing drug shortages in the U.S. limit patients’ access to essential medicines and life-saving cancer treatments, the blame largely has fallen on increased demand, quality problems, the supply chain and lack of transparency in that chain.
The U.S. FDA has awarded Locate Bio Ltd. a breakthrough device designation for its Ldgraft spine fusion product for the treatment of degenerative disk disease, paving the way to the first in human study later this year.
Wuhan Endoangel Medical Technology Co. Ltd.’s artificial intelligence (AI)-assisted real-time quality control and auxiliary diagnosis system for lower gastrointestinal endoscopy has been approved by China’s NMPA.
Artivion Inc. (formerly Cryolife Inc.) received U.S. FDA premarket application (PMA) approval of its Perclot absorbable hemostatic system and promptly sold the product line to Baxter International Inc., in keeping with the terms of an agreement announced in July 2021. Artivion will begin shipping Perclot product to Baxter following receipt of a milestone payment of $18.75 million in cash, of which $4.5 million will go to Artivion’s former partner Starch Medical Inc.
Grand Pharmaceutical Group Ltd. obtained China’s NMPA approval for an intravascular dual-mode imaging system for coronary artery imaging, tapping into a potentially huge but very undeveloped market for imaging in percutaneous coronary interventions (PCI).
The U.S. FDA granted clearance to two tests developed by Thermo Fisher Scientific Inc. to predict preeclampsia, Brahms PIGF plus Kryptor and Brahms sFlt-1 Kryptor. Both had previously received breakthrough designation. Preeclampsia, a hypertensive disorder, is the leading cause of maternal and fetal mortality and morbidity across the globe.
