Drugs
The bipartisan leadership of the House Energy and Commerce Committee is asking FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisk’s Ozempic (semaglutide) injection 1 mg in the U.S. drug supply chain (see earlier story). A 10/8 letter to FDA commissioner Robert
Devices
Sentec/Percussionaire is recalling (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an increase in reports of patient injuries after users failed to remove the blue plug from the expiratory port when applying therapy directly to a patient’s airway. “Failure to
Drugs
Researchers representing several academic institutions worldwide say FDA’s Boxed Warning for youth antidepressants has not had the intended outcome of increased monitoring for suicidal thoughts and behaviors and instead is associated with unintended reductions in doctor visits for depression, depression diagnoses, antidepressant treatment and use, and psychotherapy visits, as
Drugs
FDA reviewers are questioning whether a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome, contains adequate data to support approval. The ultra-rare genetic disease, which affects fewer than 130 individuals in the U.S., mostly occurs in males and is characterized by cardiac abnormalities
Devices
FDA has granted a de novo marketing authorization to Healgen for its over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test. The test, which is intended for use by individuals experiencing respiratory symptoms, uses a nasal swab sample to deliver at-home results in about
Devices
A 9/19-9/20 workshop sponsored by FDA and the National Institutes of Health on “Developing Implanted Brain/Computer Interface Clinical Outcome Assessments to Demonstrate Benefit” was intended to help resolve some of the hurdles that exist in commercializing that device ecosystem for brain/computer interfaces (BCI) that may
Drugs
Johnson & Johnson says that since an FDA draft guidance on Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer treatment development will replace a 2/2018 guidance when it is finalized, and ongoing trials were designed based on recommendations in the 2018 version, it would be helpful for FDA to
Drugs
A 3/25-3/30 FDA inspection at the MMC Healthcare drug manufacturing facility in Chennai, Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/24 Warning Letter says specific violations were: * failure to establish an adequate quality control unit with
Drugs
The American Hospital Association is asking the Biden Administration to require FDA to take “immediate actions to increase the supply of intravenous (IV) solutions” in the wake of product shortages caused by Hurricane Helene, particularly the closure of Baxter’s manufacturing plant in Marion, NC. The facility is a key
Drugs
Former FDA principal deputy commissioner Janet Woodcock has joined the board of directors at Every Cure, a nonprofit organization that looks at repurposing existing drugs to treat rare diseases. Over the past 15 years, the group says it helped advance 28 repurposed drugs for multiple diseases. “Our approach democratizes biomedical
Devices
Philips Respironics is recalling (Class 1 device correction) its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators regarding the use of in-line nebulizers. An in-line nebulizer is an accessory that converts therapeutic liquids (such as medication/saline solutions) into an aerosol to treat different
Drugs
FDA has placed a clinical hold on Kezar Life Sciences’ IND for zetomipzomib and its investigational use in treating lupus nephritis (LN). The agency action follows the company’s notification late last month that it was voluntarily suspending enrollment and dosing in its Phase 2b PALIZADE clinical trial of zetomipzomib
Drugs
FDA has granted a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection for treating moderate to severe opioid use disorder (OUD). The submission is seeking approval to expand treatment options under two proposed updates to the drug’s label, including: * Alternative Injection Sites: Expands
Devices
Advanced Medical Technology Association (AdvaMed) says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices it identifies, as well as ongoing input on how to incorporate the considerations and strategies outlined in a recent discussion paper entitled “Health Equity For Medical
Drugs
FDA is requesting comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute data elements and their categorization for therapeutic protein products. “Since the content of this chapter is part of the early thinking of CDER’s Office of Pharmaceutical Quality (OPQ)
Devices
Medtronic is recalling (Class 1) its MiniMed Insulin pumps due to concerns about reduced battery life in certain situations. “Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life,” a recall notice says. “Since the
Devices
FDA has cleared an Elucid 510(k) for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease. The software is designed to “objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques,” the company says, adding that it is intended
Drugs
A Reuter’s look at Thermo Fisher's Greenville, NC drug contract manufacturing plant finds that it has been inspected twice this year by FDA. The most recent inspection was in May and documented manufacturing issues related to AstraZeneca/Sanofi’s respiratory syncytial virus drug Beyfortus for infants and
Devices
FDA has updated CDRH’s Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination (SBD) requests. An agency notice says CDRH’s portal can now track the progress of PMA applications and PMA Panel-Track supplements. “Users can view their application status in near
Drugs
New FDA research shows that 22% of new molecular entities (NMEs) approved between 2009 and 2023 required postmarketing requirements (PMRs) or postmarketing commitments (PMCs) to address “knowledge gaps” on drug–drug interaction (DDI) assessments not addressed during development. “We found that 22% of NMEs had at least one DDI-related
Drugs
Johnson & Johnson is discontinuing a Phase 2 study (NCT05201794) evaluating mosnodenvir for preventing dengue virus in adults aged 18-65 years. The move to discontinue the study is part of the company’s “strategic reprioritization” of its communicable diseases research and development portfolio, J&J says, adding that
Drugs
FDA says the shortage of tirzepatide injection (Lilly’s Mounjaro and Zepbound), a glucagon-like peptide 1 (GLP-1) medication that became in short supply in 2022 due to increased demand, has been resolved. An agency notice says it confirmed with Lilly that its stated product availability and manufacturing capacity