A new-drug application was filed with the FDA by Janssen Biotech for apalutamide, which is being developed as a treatment for men with nonmetastatic castration-resistant prostate cancer. A late-stage study showed a statistically significantly extension of metastasis-free survival in patients who use apalutamide versus placebo.
Ardelyx's tenapanor, or RDX5791, met the primary and secondary endpoints in a late-stage study measuring its ability to treat irritable bowel syndrome with constipation versus a placebo after failing to meet one of its secondary endpoints in an earlier Phase III trial in the spring. The company plans to file a new-drug application with the FDA in the second half of next year.
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The US may experience limited shortages of drugs as manufacturing facilities in Puerto Rico struggle with power and related hurricane damage, said FDA Commissioner Scott Gottlieb, and the shortages could involve around 40 drugs, including those for HIV, rheumatoid arthritis and cancer. Merck said it is operating with generator power, and Bristol-Myers Squibb and Amgen said they do not expect an impact on patient supplies.
A final guidance document was issued by the National Institute for Health and Care Excellence recommending the routine use of Bayer's Stivarga, or regorafenib, in adult patients with gastrointestinal stromal tumors whose disease progressed during previous imatinib and sunitinib treatment or who are intolerant to the treatment.
A Phase I/II study of Horama's drug candidate HORA-PDE6B for the treatment of patients with retinitis pigmentosa was authorized by the French National Agency for Medicines and Health Products Safety. The study will evaluate the safety and efficacy of the drug in patients with retinitis pigmentosa brought by biallelic mutations in the PDE6B gene.
A safety alert was issued by the FDA involving dietary supplements produced by Gadget Island, such as Grande X, Rhino 7, Fifty Shades and Papa Zen, because they might contain active drug ingredients -- such as sildenafil, tadalafil and desmethyl carbodenafil -- not declared on the label. The supplements were subject to several voluntary recalls by Gadget Island, which does business as Gear Isle, because the active drug ingredients listed in the safety alert could interact with some prescription drugs and cause a potentially life-threatening drop in blood pressure.
A patent application was jointly filed by the Mayo Clinic and Boston Scientific for a self-centering guide catheter that they are developing for more efficient guidewire threading in aortic valve replacements. The filing was made as part of their intellectual property partnership that seeks to accelerate the development of medical devices.
Adhezion Biomedical's SecurePortIV catheter adhesive was granted 510(k) clearance by the FDA. The product, which reduces catheter movement, dislodgement and migration by forming a film to hold the device to the skin, may be used for improving securement, preventing catheter-related bloodstream infections, sealing insertion sites and providing a water-resistant barrier when used with short- or long-term vascular access devices.
Version 4.4.13 of iNtuition, a bone removal software for head and neck applications, was launched by TeraRecon. The updated software comes with over 175 enhancements and features, including those for spine labeling, cardiac MR and transcatheter aortic valve replacement.
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