FDA Policy/General
Shionogi reported positive results from two Phase 3 studies (COMPOSE I and II) demonstrating consistent efficacy and safety of naldemedine in treating opioid-induced constipation in patients with chronic non-cancer pain. The company says data are being presented today during the American Gastroenterological Association Presidential Plenary Session at the
FDA Policy/General
DEVICES FDA has approved a MicroVention PMA for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The low-profile visualized intraluminal support device features a braided conformable, resheathable and retrievable design that provides high metal coverage and end-to-end device visualization to support
Devices
ArjoHuntleigh Polska has recalled its Sara Plus floor lift following several complaints of smoke or flames coming out of the lift. If the device’s battery is low, the device’s printed circuit board may overheat, resulting in smoke or fire, a recall notice says. “If this situation occurs, anyone
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.” The document describes FDA’s current recommendations regarding the overall development program and clinical trial designs for developing gonadotropin-releasing hormone analogs to treat advanced prostate cancer. To view the notice,
Drugs
FDA has announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use for treating Covid-19. The extension applies to all unopened vials of bebtelovimab that
Devices
FDA has approved Medtronic’s In.Pact 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, indicated for the interventional treatment of peripheral arterial disease in the superficial femoral and popliteal arteries. The device is intended for de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm
FDA Policy/General
Federal Register notice: Health and Human Services is withdrawing a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) that was published 1/19/2021. The SUNSET final rule was scheduled to take effect 3/22/2021. However, on 3/9 a lawsuit was filed seeking to overturn
FDA Policy/General
The Senate Health, Education, Labor and Pensions Committee has introduced a bill to reauthorize FDA’s user fee programs in addition to provisions to strengthen the accelerated approval pathway, over-the-counter hearing aids, FDA inspections, and modernize diagnostic test regulation. The Senate bill, which is entitled the FDA Safety
Drugs
An analysis funded by Friends of Cancer Research finds that the breakthrough therapy designation criteria “accurately identify drugs that improve long-term outcomes for patients with cancer and warrant coordinated efforts to ensure timely coverage decisions and access for patients.” The findings were published in Clinical Cancer Research. The researchers
Drugs
Attorney Nancy Taylor (Greenberg Traurig) submitted a 5/24 petition asking FDA to take action to ensure that over-the-counter (OTC) external analgesic drug products in patch, plaster, or poultice (PPP) dosage forms claims are limited only to those that are demonstrated and do not include severe or acute
Devices
FDA says an Abbott Medical 4/11 recall of 4,800 Dragonfly OpStar imaging catheters in the U.S. is Class 1. An agency statement says the company is recalling certain lots of the catheter because the marker band farthest from the catheter tip may become loose and, in two
FDA Policy/General
Federal Register notice: FDA has announced a 7/28-29 meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. On 7/28, the committee will discuss skin lesion analyzer technology and its application in detecting skin cancers in various patient care settings. In recent
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). The collection supports FDA’s authority to require a manufacturer to conduct postmarket surveillance on any device that meets the criteria set forth
Devices
FDA has approved ManaMed’s Class 2 ManaSport ultrasound therapy device that is labeled to provide pain relief and treatment for soft-tissue injuries. The company says the device can be prescribed by medical professionals and is intended for supervised use. It is said to provide non-invasive pulsed ultrasound
Drugs
FDA has granted fast track designation for Pfizer’s investigational combination therapy of ervogastat and clesacostat to treat non-alcoholic steatohepatitis. A Pfizer announcement says FDA’s decision was informed by the results of the company’s nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat that showed
Drugs
FDA has granted Tvardi Therapeutics an orphan drug designation for TTI-101 for treating idiopathic pulmonary fibrosis (IPF). TTI-101 is described as an orally-delivered, small molecule, direct STAT3 inhibitor. “STAT3 has emerged as a central node of fibrosis and has been found to accumulate in the fibrotic lungs
Drugs
FDA has approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) in combination with azacitidine (Bristol-Myers Squibb’s Onureg) for newly-diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test in adults age 75 or older who have comorbidities that preclude using intensive induction chemotherapy. An
Drugs
FDA has accepted for priority review a Reata Pharmaceuticals NDA for omaveloxolone for treating patients with Friedreich’s ataxia. The submission is based on data from the MOXIe Part 2 trial and additional supporting data from the MOXIe Part 1 and MOXIe Extension trials, according to the company. The agency
Drugs
U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) 5/26 introduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act that would give FDA authority to deny a new drug application for an opioid analgesic drug if it isn’t
Biologics
FDA has denied a 3/23/21 petition for reconsideration submitted by the Informed Consent Action Network (ICAN) concerning the agency’s denial of ICAN’s 10/16/20 original petition asking it to amend the study design for a Phase 3 trial of Johnson & Johnson’s Covid-19
FDA Policy/General
Federal Register notice: FDA is announcing that it is withdrawing certain indications that received accelerated approval in a Gilead NDA for Zydelig (idelalisib) because the firm failed to demonstrate a clinical benefit in required postmarketing trials. The indications being withdrawn are for relapsed follicular lymphoma and relapsed small lymphocytic lymphoma.
Drugs
FDA has issued a complete response letter to Verrica Pharmaceuticals for its NDA for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Control as an infection caused by the molluscum contagiosum virus. The result of the infection is usually a benign, mild skin disease characterized by