Drugs
FDA has accepted for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for treating first-line advanced non-small cell lung cancer in patients with tumor mutational burden greater than or equal to 10 mutations per megabase. The user fee review action target
Devices
Draeger Medical Systems has begun a Class 1 recall of its Jaundice Meter JM-103 and JM-105 models which are used to measure bilirubin in newborn infants. The meters are being recalled because users have misinterpreted display messages, resulting in serious injuries. Some users have interpreted the display messages
Devices
FDA has permitted the de novo marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis. The devices, Avenu Medical’s Ellipsys Vascular Access System and TVA Medical’s everlinQ endoAVF System, are intended for use
Devices
FDA has approved the use of Medtronic’s MiniMed 670G insulin delivery system in patients with Type 1 diabetes seven years of age and older. The device features the company’s SmartGuard technology and Guardian Sensor 3, which work together to automate the delivery of a personalized amount of basal
FDA Policy/General
Federal Register notice: FDA has classified the next-generation sequencing-based tumor profiling test into Class 2 (special controls). The action is in response to a 2017 Memorial Sloan-Kettering Cancer Center Department of Pathology de novo classification request for its MSK–IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets)
Drugs
FDA has approved an Impel NeuroPharma IND for a Phase 3 clincial trial of INP104, a novel, dihydroergotamine (DHE) intranasal product for treating acute migraine. The drug is dosed via Impel’s proprietary Precision Olfactory Delivery. INP104 delivers DHE to the “richly vascularized upper nasal cavity, offering rapid bioavailability without
Biologics
CBER says it is planning to develop 15 guidances during calendar year 2018. The guidances are grouped under two categories — blood and blood components and tissues and advanced therapies.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” The document provides recommendations to applicants planning to request such waivers or reduced user fees. It is a revision of the 2011 guidance entitled “User
FDA Policy/General
Federal Register notice: FDA has announced an 8/8 Antimicrobial Drugs Advisory Committee meeting. Panel members will review two Paratek Pharmaceuticals NDAs for omadacycline tablets and omadacycline injection, indicated for treating community acquired bacterial pneumonia and acute bacterial skin and skin structure infections. To view the notice, click here.
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the goals of the 2017 Food and Drug Reauthorization Act to advance research and development of medicines for children with cancer. The association’s letter submitted in advance of the 6/20 meeting of the Pediatric Oncology Subcommittee of
Drugs
FDA has withdrawn a 9/2017 draft guidance, Statistical Approaches to Evaluate Analytical Similarity, that was intended to provide advice for sponsors developing biosimilar products about the evaluation of analytical similarity between a proposed biosimilar product and a reference product. “After considering public comments that the agency received about the
Devices
FDA has cleared a Tenon Medical 510(k) for the Catamaran Sacroiliac Joint Fixation System, indicated for sacroiliac joint fusion for conditions including joint disruptions and degenerative sacroilitis. The company says the device becomes the first patented single implant sacroiliac joint fusion system using a true posterior approach for minimal
Drugs
CDER has denied two petitions asking it to deny approval for a Ferring NDA for Nocdurna (desmopressin) sublingual tablets to treat nocturia due to nocturnal polyuria, and has approved the Nocdurna NDA. The denial letter says the petitions were submitted by Serenity Pharmaceuticals and Avadel Specialty Pharmaceuticals. The letter notes
Devices
FDA has approved the Senseonics Eversense continuous glucose monitoring system for use in people age 18 and older with diabetes. The agency says it is the first such device approved with a fully implantable sensor to detect glucose that can be worn for up to 90 days. According to the
Drugs
In a disclosure reminiscent of others over decades involving pharmaceutical marketing abuses of FDA-approved drugs with devastating side effects and lax FDA labeling enforcement, CBS Evening News 6/21 reported a former Purdue Pharma sales person’s allegation of scientifically unsubstantiated “pseudoaddiction” claims about the company’s blockbuster opioid
Drugs
FDA has issued Staar Surgical a close-out letter that lifts a Warning Letter dated 5/21/2014, a signal that the company has corrected all issues to the agency’s satisfaction. The company says that the action is the “result of a comprehensive remediation program that not only addressed
Drugs
FDA says it is issuing a draft guidance, Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, with recommendations to applicants planning to request a waiver or reduction in user fees. A Federal Register 6/21 notice says the draft revises a 9/2011 guidance.
Drugs
The DC federal court has granted summary judgment to Eagle Pharmaceuticals in its case challenging FDA’s denial of orphan drug exclusivity for the company’s Bendeka (bendamustine), which has been designated as an orphan drug and approved to treat two rare forms of cancer. FDA had argued that it
Devices
The Justice Department says a federal grand jury has indicted Theranos founder Elizabeth Holmes and the company’s former chief operating officer Ramesh Balwani on two counts of conspiracy to commit wire fraud and nine counts of wire fraud. A department news release says the charges stem from allegations that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0800). To view the notice, click here.
Drugs
FDA has designated Acurx Pharmaceuticals’ lead antibiotic product candidate, ACX-362E, as a qualified infectious disease product. The designation was granted for the drug’s use in treating patients with Clostridium difficile infection. ACX-362E is being developed as a targeted, narrow spectrum oral antibiotic, and a Phase 1 clinical
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of five NDAs from multiple applicants. The NDA holders have notified the agency that the products are no longer marketed. To view the notice, click here.