Medical device
At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals.
Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.
The specialty pharmaceutical company has twice filed for bankruptcy in recent years, driven by opioid-related litigation. Mallinckrodt’s deal with CVC will allow it to pay off more than half of its net debt.
Fresh off its $13-billion acquisition of medical devices developer Shockwave Medical, Johnson & Johnson is expecting greater business growth in the future.
Following the regulatory victory of Balversa in urothelial carcinoma, Johnson & Johnson on Friday continued its bladder cancer winning streak with an 82.8% complete response rate forTAR-200 in high-risk non-muscle invasive bladder cancer.
Fresh from its IPO, Fractyl Health got an Investigational Device Exemption from the FDA, clearing a pivotal study of its Revita system to help maintain weight loss following the discontinuation of GLP-1 drugs.
Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.
Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
Nearly three-quarters of the highest-revenue U.S. patient advocacy organizations have board members or senior leadership with ties to the pharma or medical device industries, finds study.
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
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