Noteworthy news from medtech start-ups. This month we feature PlaqueTec, which is pursuing vulnerable plaque biomarkers and druggable targets, Ozics, which is developing a bone reinforcement composite, and Phagenesis, which is using neurostimulation to treat dysphagia in stroke patients.
You may also be interested in...
FDA’s Califf Calls For Return To Large, Simple Trials Without The ‘Useless Stuff’ That Slows Development
US FDA Commissioner Califf praises both Project Pragmatica and the ‘very powerful’ partnership between OCE Director Rick Pazdur and National Cancer Institute Director Monica Bertagnolli.
California Prop 65 Complaints Against OTC Generics? Ranitidine Could Be First And Last Target
Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.
Federal Preemption Strikes California Prop 65 Complaint Against Generic OTC Ranitidine Firms
Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.