Drugs
BioMarin says it will file by the end of the year an NDA for pegvaliase and its use in treating genetic disorder phenylketonuria (PKU). The decision to submit an NDA follows just-announced Phase 3 results from the PRISM-2 study, which showed the drug significantly lowered levels of phenylalanine,
Devices
CDRH has posted a final guidance on “Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.” The document provides an assessment paradigm for multi- and single-component device types with various dimensions and shapes. “Multi-component passive devices, such as orthopedic fixation
Drugs
FDA has approved an Apotex ANDA for a generic copy of Merck’s Nasonex (mometasone furoate) Nasal Spray, indicated for treating nasal symptoms of seasonal allergic and perennial allergic rhinitis in adults and pediatric patients two years of age and older. It is also indicated for preventing seasonal allergic rhinitis
Drugs
FDA has accepted for review an Anacor Pharmaceuticals NDA for crisaborole topical ointment, 2%, a non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor for treating mild-to-moderate atopic dermatitis in children and adults. The agency has set a user fee review target date of 1/7/2017.
Drugs
FDA has approved an Eli Lilly NDA for Taltz (ixekizumab), indicated for treating adults with moderate-to-severe plaque psoriasis. The drug works by binding to a protein (interleukin (IL)-17A) that causes inflammation. “By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a
Drugs
The Federal Trade Commission (FTC) is signaling an interest in the integrity of data cited by companies to support marketing claims. Attorneys Raqiyyah Pippins and Neha Patel (Arnold & Porter) write in an online post that in a letter defending its finalized consent order with Carrot Neurotechnology, FDA said that
Drugs
At the same time that it required sweeping safety labeling changes for immediate-release opioid analgesics, FDA granted in part a Purdue Pharma 1/17/15 petition calling for such changes, although not for the reasons cited by Purdue. The petition had called on the agency to: promptly exercise its
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Alikay Naturals/Black Onyx World, LLC Fort Myers, FL (3/16). Unapproved new drug, misbranded: FDA laboratory analysis determined that “Bentonite Me Baby” contains lead at levels of 37.
Drugs
Stakeholders say they appreciate the work FDA has put into its pilot Clinical Outcome Assessment (COA) compendium, and offer ways in which it can be improved. The Association of Clinical Research Professionals (ACRP) says that the compendium focuses on current FDA guidance. “Without validated outcomes tools, the probability that any
FDA Policy/General
Federal Register Proposed rule: FDA has determined that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices. FDA is confronted with an increasing number of premarket submissions that include an MR conditional labeling claim for multiconfiguration passive medical devices. The
FDA Policy/General
Federal Register Notice: FDA and the Parenteral Drug Association will co-sponsor a public conference 9/12-14 entitled: “Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance.” It will cover current issues affecting the industry as well as explore strategies to facilitate the development and continuous improvement
FDA Policy/General
FDA said 3/21 that its Center for Veterinary Medicine has approved Leawood, KS-based Aratana Therapeutics’ Galliprant (grapiprant tablets), indicated to control osteoarthritis pain and inflammation in dogs. An agency release said the drug is a new treatment option for dogs with this condition. It is a prostaglandin E2
Drugs
Hospira has recalled one lot of 8.4% sodium bicarbonate injection (NDC: 0409-6625-02, lot # 56-148-EV, expiry 8/1/2017) due to the presence of a particulate discovered in a single–dose glass fliptop vial. “If the particulate is not observed prior to IV administration and breaks
Devices
FDA has proposed a ban on powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove. An agency notice says that while their use is declining, they still “pose an unreasonable and substantial risk of illness or injury to health care providers, patients
Drugs
FDA has approved an Elusys Therapeutics NDA for Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with antibacterial drugs. It is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. The monoclonal antibody is designed to neutralize toxins produced by B. anthracis. The
Biologics
Biotechnology Innovation Organization (BIO) has urged FDA to state explicitly in a planned final guidance on “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application” that repackaged biological products should satisfy the same sterility requirements in place for products manufactured under approved BLAs. In
Devices
Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS) have introduced legislation (S.2737) to improve the effectiveness of medical device operations at FDA. They say the bill, which has been referred to the Senate HELP Committee, would: Provide greater predictability and transparency to FDA’s process for recognizing
Drugs
Merck has agreed to pay Harvard University $20 million under an exclusive license and research collaboration agreement with Merck to further develop small-molecule therapeutics for leukemia and other cancers. The novel compounds, developed in the laboratory of Harvard scientist Matthew Shair, offer an innovative approach to cancer treatment by
Devices
FDA has approved Roche’s hepatitis C virus (HCV) quantitative RNA test to be used as an aid in diagnosing HCV infection for certain patient populations. Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 can now be used to confirm an active hepatitis infection, in addition to
Devices
FDA has cleared a Vermillion 510(k) for its Overa OVA1 test for determining ovarian cancer risk in conjunction with independent clinical and imaging assessment prior to planned surgery for a women with a pelvic mass. The second generation OVA1 test replaces two of the five OVA1 biomarkers in the
Devices
FDA has cleared an Olea Medical 510(k) for its Olea Sphere 3.0 medical imaging software package, which is intended for picture archiving, post-processing and communication. The software is designed to help standardize both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with magnetic resonance