Janssen seeks FDA approval of prostate cancer drug | FDA accepts biologics application for rickets treatment | Ardelyx to file NDA of IBS drug next year
October 12, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Janssen seeks FDA approval of prostate cancer drug
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.
Seeking Alpha (free registration) (10/11) 
FDA accepts biologics application for rickets treatment
Burosumab, a treatment for X-linked hypophosphatemia, a heritable form of rickets, from Ultragenyx Pharmaceutical and Kyowa Hakko Kirin International was accepted for priority review by the FDA.
Rare Disease Report (10/10) 
Ardelyx to file NDA of IBS drug next year
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.
BioCentury (10/11) 
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
Global Focus
FDA: Puerto Rico disruptions could mean some drug shortages
FDA: Puerto Rico disruptions could mean some drug shortages
(Joe Raedle/Getty Images)
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.
Reuters (10/10) 
Bayer's gastrointestinal stromal tumor drug recommended by NICE
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.
PharmaTimes (U.K.) (10/12) 
Horama authorized by French regulator to launch retinitis pigmentosa drug study
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.
European Pharmaceutical Review (U.K.) (10/11) 
Food & Dietary Supplements
FDA alerts consumers about undeclared drug-containing dietary supplements
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.
The National Law Review (10/11) 
Medical Devices
Boston Scientific, Mayo Clinic seek patent for heart surgery device
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.
Twin Cities Business (Minneapolis) (10/11) 
FDA clears Adhezion Biomedical's catheter adhesive
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.
FDAnews (10/12) 
New version of iNtuition software debuted by TeraRecon
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.
AuntMinnie (free registration) (10/11) 
Food and Drug Law Institute Highlights
In two weeks -- Tobacco Regulation and Policy Conference: For the Tobacco Products Industry
In two weeks -- Tobacco Regulation and Policy Conference: For the Tobacco Products Industry
Oct. 26-27 | Washington, D.C.
Join industry stakeholders for interactive dialogues on tobacco regulation practices in both the US and around the globe. Register today.
Introduction to US Tobacco Law and Regulation
Introduction to US Tobacco Law and Regulation
Oct. 25 | Washington, D.C.
Curious how FDA law and regulations affect the tobacco industry? This course covers all, from Premarket Tobacco Applications (PMTA) and Modified Risk Tobacco Product Applications (MRTPA) to the FDA's Deeming Rule. Learn more.
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