Drugs
FDA has issued SteadyMed Ltd. a Refuse-to-File letter on its NDA for Trevyent (treprostinil) for treating pulmonary arterial hypertension. The agency determined that the application is not sufficiently complete to permit a substantive review, according to the company. “FDA has requested further information on certain device specifications and
Drugs
Lilly and Incyte say they will resubmit their NDA for baricitinib, including new safety and efficacy data, before the end of 1/2018. The decision follows discussions with FDA at the end of August, the companies say. They expect the agency will classify the application as a Class 2 resubmission,
Drugs
FDA has approved a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating tardive dyskinesia in adults. Previously, the product was approved for treating chorea associated with Huntington’s disease. The latest approval was based on data from two Phase 3 randomized, double-blind, placebo-controlled, studies (AIM-TD
Devices
FDA will publish 8/31 a guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, to clarify how the agency evaluates real-world data to determine if they are sufficiently relevant and reliable to generate the types of real-world evidence that can be used
FDA Policy/General
Federal Register notice: FDA has made available a draft revised guidance for industry on generic digoxin tablets. The document, “Draft Guidance on Digoxin,” is intended to provide product- specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs for digoxin tablets. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced it is withdrawing approval of an Upsher-Smith Laboratories ANDA for propranolol hydrochloride extended-release capsules due to concerns about the validity of bioequivalence data submitted from studies conducted by an unnamed contract research organization. The agency notified the company in 2011. Subsequently, Upsher-
Drugs
FDA says it has approved Novartis’ Kymriah (tisagenlecleucel) as the first gene therapy available in the U.S. An agency statement says Kymriah is indicated for treating certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Specifically, it is approved in the U.S. for
Biologics
FDA has extended by three months a Biocon BLA for a proposed trastuzumab biosimilar product (Roche’s Herceptin), indicated for HER2-positive breast cancer and gastric cancer. The company said that the agency “has notified our partner Mylan that they will extend the target action date” to 12/3 in
FDA Policy/General
FDA has released the FDA-483 issued following a 2/22-4/7/16 agency inspection at Wickliffe Pharmaceutical, a Lexington, KY, veterinary drug product producer. The document lists two inspection observations: * reprocessing procedures lack the steps to be taken to ensure that reprocessed batches will conform with all established
Devices
In a letter to healthcare professionals, FDA is reminding them that using thermoregulation devices during surgery, including forced air thermoregulating systems, have resulted in less bleeding, faster recovery times, and decreased risk of infection for patients. The agency says it recently became aware that some health care providers and patients
Devices
A CDRH webinar on the Medical Device Development Tools (MDDT) voluntary qualification program listed its benefits as (1) leveraging advances in regulatory science that help to bridge the gap between research and development of medical devices and the delivery of high quality, safe, and effective devices to patients; and (2)
Drugs
FDA has accepted an Amgen supplemental NDA for Kyprolis (carfilzomib) and dexamethasone that includes overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that the therapies reduced the risk of death by 21% and increased OS by 7.6 months versus Velcade (bortezomib) and dexamethasone
Devices
FDA has cleared a Smiths Medical 510(k) for the CADD-Solis ambulatory infusion pump with wireless communication. The company says the device can communicate wirelessly with the company’s PharmGuard Server software for updates, access to drug libraries, and remote managing of pump performance and drug dosing. It also
Drugs
A 12/7-12/16/16 FDA inspection at Hetero Labs Ltd., Telangana, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to an 8/15 Warning Letter. Specific violations cited in the letter were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has sent Acorda Therapeutics a Refusal to File letter for the NDA for its Inbrija (levodopa inhalation powder), an investigational treatment for symptoms of off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The company reports that FDA found that Acorda’s 6/26 NDA
Devices
FDA says it has approved a firmware update to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities in some Abbott (formerly St. Jude Medical) pacemakers. An agency safety communication says the update is for the Accent, Anthem, Accent MRI, Accent ST, Assurity, and Allure implantable
FDA Policy/General
Federal Register notice: FDA has announced medical device user fee rates and payment procedures for fiscal year 2018. The rates are as follows: 510(k) $10,566; de novo classification $4,195; PMA/PDP/BLA $310,754; panel track supplement $233,073; 180-day supplement $46,615; annual report $10,
Biologics
FDA has approved a Boehringer Ingelheim Pharmaceuticals BLA for Cyltezo, a biosimilar version of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. Cyltezo is approved for the following indications in adult patients: * moderately to severely active rheumatoid arthritis; * active psoriatic arthritis; * active ankylosing spondylitis (an arthritis that affects the spine)
Drugs
Responding to varying results in the REVEAL study of anacetrapib, Merck’s investigational cholesteryl ester transfer protein inhibitor, the company says it is reviewing the trial results with external experts and considering whether to submit an NDA to FDA. The study of 30,449 patients with atherosclerotic vascular disease receiving
Drugs
Bristol-Myers Squibb and Daiichi Sankyo say they are collaborating on a clinical trial to evaluate the combination of BMS’ immunotherapy Opdivo (nivolumab) and Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and urothelial cancers. The multicenter Phase 1b open-label study will look
Drugs
An FDA biomarker qualification program online post says that a biomarker context of use (CoU) “is a statement that describes the manner and purpose of use for the biomarker in drug development. The supporting data and analyses submitted with the biomarker qualification submission determine the acceptability of the qualified CoU.
FDA Policy/General
Federal Register notice: FDA has announced fiscal year 2018 rates for generic drug user fees. Application fees are: ANDA ($171,823) and Drug Master File ($47,829). Facility fees are: domestic API facility ($45,367), foreign API facility ($60,367), domestic finished dosage facility ($211,087), foreign finished dosage facility