Drugs
Metal Expandable Biliary Stents Guide Federal Register notice: FDA makes available a final guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k) Submissions.” 07/26/2019 Info Collection on Device Export Approval Letters Federal Register notice: FDA sends to OMB an information collection extension for “Export of Medical Devices;
FDA Policy/General
DEVICES FDA has approved a Cook Medical PMA for its lower-profile Zenith Alpha Thoracic Endovascular Graft, indicated for the endovascular treatment of patients with isolated lesions within the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair. The device features a 16-20 French delivery
FDA Policy/General
Daiichi Sankyo, Inc., the U.S. subsidiary of Daiichi Sankyo Company, will establish a new U.S. headquarters in Basking Ridge, NJ to continue collaboration between the business segments, enabling innovation in its existing and emerging therapeutic areas such as cardiology, oncology, pain and other areas where there are unmet
Drugs
FDA has posted a final guidance entitled “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.” The document addresses the agency’s current thinking regarding the overall development program and clinical trial designs for systemic drugs administered to the kidney transplant recipient to support an indication of preventing delayed
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions.” It provides recommendations for information and testing that should be included in submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant
Drugs
The Senate Finance Committee has voted 19-9 to advance the Prescription Drug Pricing Reduction Act (see earlier story). The Congressional Budget Office scored the bill and said it would save taxpayers, patients and the government $130 billion. If signed into law, committee leaders said the measure would modernize and
Drugs
FDA has approved a Black Boxed warning about an increased risk of blood clots and death with Pfizer’s tofacitinib (Xeljanz, Xeljanz XR) 10 mg twice daily dose,which is used in patients with ulcerative colitis. In addition, tofacitinib’s use for ulcerative colitis will be limited to certain patients
Devices
FDA has cleared a MiRus 510(k) for the Cygnus Anterior Cervical Plate System. The device features an “I-beam design“ and the metal alloy used in the plate allows for a smaller footprint than other marketed devices, the company says. Its narrower profile will lead to “less retraction and
Drugs
FDA has granted Aeglea BioTherapeutics a breakthrough therapy designation for pegzilarginase, indicated for treating Arginase 1 Deficiency, a rare progressive disease presenting in early childhood that results in severe complications and early mortality. The designation is based on data from a Phase 1/2 and ongoing Phase 2 open-label
Drugs
FDA has cleared a Resonea 510(k) for the Drowzle Sleep Apnea Pre-screening Device, a smartphone app that records and analyzes respiratory patterns during sleep for the purpose of in-home screening for obstructive sleep apnea. Results from the app are intended to be used to assist healthcare professionals
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Requesters communicate with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office
Drugs
FDA has released the FDA-483 issued following a 5/7-5/31 inspection at QuVa Pharma, a Bloomsbury, NJ, outsourcing facility. The six inspections observations were: * the quality control unit lacks responsibility to approve and reject all procedures or specifications affecting the identity, strength, quality, and purity of drug
FDA Policy/General
House Energy and Commerce Committee leaders are asking FDA to explain its slower than expected progress with manufacturers and providers of stem cell products to come into compliance with FDA’s guidance and premarket approval requirements, including those established by the 21st Century Cures Act. The 7/25 letter to
Drugs
Bristol-Myers Squibb says that part 2 of the Phase 3 CheckMate-227 trial did not meet the primary endpoint of overall survival with its Opdivo (nivolumab) plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer, regardless of PD-L1 status. The company
Devices
FDA has published a guidance, Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions, with recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. The document says the devices are intended to provide luminal patency of the biliary tree for palliation of malignant strictures.
FDA Policy/General
Federal Register notice: FDA has set the following generic drug user fee rates for fiscal year 2020: ANDA ($176,237), drug master file ($57,795), domestic API facility ($44,400), foreign API facility ($59,400), domestic finished dosage form facility ($195,662), foreign finished dosage form facility ($210,662), domestic
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Requesters communicate with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office
Drugs
FDA has accepted for priority review an Epizyme NDA seeking accelerated approval for tazemetostat, indicated for treating metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The agency has set a user fee review action target date of 1/23/2020. The submission is based primarily on data
Drugs
Citing information from industry sources, multiple media outlets are reporting that the Trump administration is looking at ways to lower prices for almost all prescription drugs sold to Medicare and other government programs by tying prices the programs would pay to lower prices in other countries. Reuters says White House
FDA Policy/General
Federal Register notice: FDA is seeking comments on the agency’s publication of a glossary of terms which is part of the BEST (Biomarkers, Endpoints, and other Tools) Resource Taxonomy. FDA has developed a Web page that describes the resource, which links to the official National Library of Medicine Web
Drugs
FDA has approved an Eli Lilly NDA for Baqsimi (glucagon) nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. “This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since
Drugs
FDA has accepted for review a resubmitted Correvio Pharma NDA for Brinavess (vernakalant HCl, IV), an antiarrhythmic drug for rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. The agency assigned a target PDUFA action date of 12/24. Correvio says the Brinavess NDA is supported