Drugs
FDA has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents 12 years of age and older with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed. Approval is based on data from the DANCE study
Drugs
FDA has accepted for review a Stealth BioTherapeutics NDA for elamipretide for treating Barth syndrome. The submission is based on data from the SPIBA-001 Phase 3 Natural History Control Study and additional supporting efficacy and safety data from the TAZPOWER Part 2 baseline-controlled trial, according to the company.
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar for five years Robert Lance Shuffert from importing or offering for import any drug into the U.S. The order is based on a finding that Shuffert was convicted of one felony count of intent to defraud and mislead, causing
Drugs
FDA has approved a Bristol Myers Squibb and 2Seventy Bio supplemental BLA for Abecma (idecabtagene vicleucel; ide-cel) for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal
Devices
Honeywell Safety Products is recalling its Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station after a supplier of the cartridge was found to be non-compliant with GMP requirements. “Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range
Drugs
FDA has granted Daiichi Sankyo an accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Approval was based on data from 192 adult patients with
Drugs
FDA has issued Jubilant Generics a four-observation Form FDA-483 after inspecting the firm’s Roorkee, Uttarakhand, India facility in February. The inspection cited the firm for not making written records for all investigations into unexplained discrepancies. FDA also took issue with the quality control unit and its responsibilities
Drugs
AbbVie has petitioned FDA urging it to crack down on newly introduced unlicensed desiccated thyroid extract (DTE) products. The company acknowledges that it makes Armour Thyroid (thyroid tablets, USP), an unlicensed DTE product that has been used in the U.S. since the early 1900s for treating hypothyroidism and other
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in selecting a nonvoting industry representative to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee. The agency is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on the committee. A nominee may either be
FDA Policy/General
Federal Register notice: FDA is announcing a 5/22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. Panel members will discuss the implementation of amendments to section 505B of the Federal Food, Drug, and Cosmetic Act that requires pediatric investigations of certain targeted cancer drugs for original applications
Devices
Some 31 experts in genetics, addiction, psychiatry, public health, and medical device regulation are asking FDA to revoke its 1/2 approval of AutoGenomics’ AvertD, the first test to use DNA to assess whether individuals may have an increased risk of developing opioid use disorder (OUD). In a 4/4
Devices
CDRH says it issued 45 safety-related communications between 1/1/2022 and 12/31/2022. In a report to Congress mandated by the Consolidated Appropriations Act of 2023, which was posted six months past its due date, CDRH says there were 30 Medical Device Safety Communications and 15 Letters
Devices
FDA says the 2/2 Medos International Sàrl recall of the Cerenovus Cerebase DA guide sheath neurovascular catheter is Class 1. The company recalled 1,343 devices in the U.S. An FDA notice says the company recalled the sheaths after complaints describing fractures of the distal catheter shaft. Using
Drugs
Liquidia says it has submitted to FDA a 3/28 decision by the Delaware federal court setting aside an injunction that it issued in 8/2022 in a suit filed by United Therapeutics to prevent the agency from granting final approval to Liquidia’s Yutrepia (treprostinil) inhalation powder. A Liquidia
Drugs
Novartis says it will seek FDA approval in the second half of this year for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — to slow disease progression in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer after treatment with androgen receptor pathway inhibition
Biologics
Four Hogan Lovells attorneys say a discussion paper published by CBER, CDER, CDRH, and the Office of Combination Products on artificial intelligence (AI) and medical products aims to provide greater transparency on how the agency’s Centers are collaborating to safeguard public health while fostering responsible and ethical innovation. The
FDA Policy/General
FDA commissioner Robert Califf is scheduled to testify before the House Committee on Oversight and Accountability 4/11 at a hearing that’s likely to ratchet up political pressure through intensifying committee investigations into FDA responses to several issues, including drug shortages, facility inspections, hemp regulation, regulation of tobacco and
Drugs
After reporting disappointing data last month from the Phase 3 PHOENIX clinical trial of Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate and taurursodiol), the company says it is voluntarily removing the drug from U.S. and Canadian markets. At the time the data came out, Amylyx said
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The document provides recommendations to the dietary supplement industry on master files for new dietary ingredients. It is intended to help industry comply more easily with the new dietary ingredient
Drugs
Smiths Medical is recalling its PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the device may intermittently provide continuous positive gas flow instead of the intended cycling like human breathing when it is switched to the “ventilate” operating mode. “This non-cycling and continuous positive gas
Drugs
Responding to a comment submitted by former FDA Office of Orphan Product Development director Timothy Cote on a Sidley 11/2/2023 petition submitted on behalf of a client involving orphan drug exclusivity (ODE) for an investigational oral vigabatrin solution, Sidley says Cote’s arguments “are frivolous and should be
Drugs
FDA has approved a new indication for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults for Vanda Pharmaceuticals’ Fanapt (iloperidone). A company statement says Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since