Drugs
Amarin has submitted a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular (CV) outcomes study. “The REDUCE-IT results support that approximately one fewer major cardiovascular adverse event would occur on average for every six patients treated with Vascepa
Drugs
FDA is proposing new rules as part of a multi-year effort to change the way drugs are manufactured in an attempt to improve the safety of the nation’s drug supply. Bloomberg News reports that currently FDA mostly relies on the drug industry to police itself. “That approach has
Drugs
Attorneys Lucas Przymusinski and Matt Holian (DLA Piper) say a 2nd Circuit Court of Appeals decision upholding lower court actions in multi-district litigation against Bristol-Myers Squibb and Pfizer over their anticoagulant Eliquis significantly strengthens preemption law. In an online analysis, they say the appeals court upheld lower court
FDA Policy/General
Federal Register proposed rule: FDA has proposed to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic Act to modernize the regulations by incorporating current science and mammography best practices. The updates are intended to improve the
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/28/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling.” The document is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in
Devices
FDA Commissioner Scott Gottlieb has reversed course on certain device summary reporting about adverse events that are hidden to the public and researchers, and now says the agency will make such reports received prior to 2017 more easily accessible. “I think that the imperative of the agency is to make
Drugs
FDA has approved UCB’s Cimzia (certolizumab pegol) injection for treating adults with non-radiographic axial spondyloarthritis, with objective signs of inflammation. An agency news release says this is the first approved treatment for this condition. Cimzia’s efficacy was studied in a trial of 317 adult patients with objective
Drugs
New York attorney general Letitia James has filed what she says is the nation’s most expansive lawsuit against the manufacturers, Sackler family, and distributors of opioids for their role in the nation’s opioid epidemic. The suit, which expands an earlier complaint against Purdue Pharma, alleges that through years
Devices
FDA has cleared a Hitachi Chemical Diagnostics 510(k) for its new high capacity allergy testing instrument, Optigen AP 3600. The device delivers increased throughput and “true walk-away time” compared with its current device, the company says, adding that it can process up to 100 panels, or as many
Drugs
FDA commissioner Scott Gottlieb told a Senate Appropriations Committee subcommittee 3/28 that a new comparative standard is needed for approving new opioid drugs. Gottlieb made the comment during a hearing into the FDA FY 20 budget request that includes a 5.5% increase over FY 19, one of the
Drugs
FDA has granted Imbrium Therapeutics an orphan drug designation for its investigational drug EDO-S101 (tinostamustine), a potentially first-in-class alkylating deacetylase inhibiting molecule being studied in early phase clinical trials for treating T-cell prolymphocytic leukemia (T-PLL). The extremely rare and aggressive T-cell leukemia is characterized
Drugs
FDA has approved a Novartis NDA for Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Approval is based on data from a 1,651-patient clinical trial that compared Mayzent to placebo in patients
Drugs
FDA has issued a guidance, Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling, to help applicants determine the appropriate placement and content of pediatric information in human prescription drug and biological product labeling. The document says its goal is to provide recommendations to help ensure that information
Devices
DC federal court chief judge Beryl Howell says both FDA and the Judge Rotenbergng Educational Center (JRC) have fallen short in their arguments in a complex Freedom of Information Act (FOIA) case on the agency’s decision to propose a rule to ban use of the Graduated Electronic Decelerator, an
Drugs
The FDA Oncology Center of Excellence (OCE) 2018 annual report describes steps taken to get the Center up and running since its 1/2017 establishment as authorized by the 21st Century Cures Act. Director Richard Pazdur writes that OCE “has collaborated with FDA’s medical products Centers to expedite many
FDA Policy/General
Federal Register notice: FDA has announced a 4/29 regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The purpose of the public meeting is to provide information
FDA Policy/General
Federal Register notice: FDA has announced a 5/2 annual meeting of the Reagan-Udall Foundation that will discuss its activities and how they support FDA. Center officials will also hold a panel discussion on pressing FDA initiatives suitable for public-private partnerships. To view the notice, click here.
Drugs
A Washington Post article reports that Gilead Sciences is fighting to prevent the U.S. government from reaping any financial benefit for discovering a use for an HIV drug on which the company makes $3 billion annually. Federal grants from the Centers for Disease Control funded research that proved Gilead’
FDA Policy/General
FDA, along with many other federal agencies, is watching how the Supreme Court handles a case testing the long-standing notion that courts should defer to federal agencies in the agencies’ interpretation of their own regulations. Although the case before the high court involves veterans’ benefits, observers say the decision
Devices
FDA has cleared a MiRus 510(k) for the MoRe-based Europa Pedicle Screw System, which the company says is the first cleared medical device with this new class of implant material. MoRe is characterized as a proprietary molybdenum rhenium superalloy for medical implants. The material “allows for the design
FDA Policy/General
FDA says the iMedDo Web site takes orders for NeuSilver Colloidal Silver and NeuKids lower dose silver for pets and children. A just-released 2/19 Warning Letter gives examples of Web site claims that provide evidence that the products are intended for use as drugs. Since the products are