Drugs
FDA has approved a scPharmaceuticals supplemental NDA for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease. Previously, Furoscix was approved for treating edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure. The company says
Drugs
Participants at a 5/2-5/3/2024 public discussion hosted by FDA and the Center for Research on Complex Generics on “Pathways for Regulatory Acceptance of Dynamic Tools in the New Drug Space” found that model-based approaches like physiologically-based pharmacokinetics and population pharmacokinetics, when validated for their
Devices
FDA has granted both Breakthrough Device and Targeted Acceleration Pathway designations to Phantom Neuro’s Phantom X platform. The company describes the platform as a “minimally invasive neural interface providing intuitive control of prosthetics and robotic devices.” It says Phantom X uses sophisticated algorithms to decode natural human movement, providing
FDA Policy/General
FDA commissioner-nominee Marty Makary has pledged to do his own “independent assessment on personnel” before recommending if any additional staff cuts are warranted at the agency. During his 3/6 Senate confirmation hearing before the Health Education Labor & Pensions (HELP) Committee, Makary made the promise to appease criticism
Devices
FDA has published a medical device early alert about an issue with the Baxter Sigma Spectrum Infusion System and Spectrum IQ Infusion System. The alert says Baxter has contacted affected customers recommending that certain Spectrum infusion pumps be removed from where they are used or sold. The notice says Baxter
FDA Policy/General
The Trump Administration is reversing an Elon Musk decision (see earlier story) to terminate the lease of a 52,000 square foot major FDA laboratory in St. Louis, MO. Despite its continued listing on Musk’s Department of Government Efficiency (DOGE) “Wall of Receipts” as saving $2.5 million annually
Drugs
FDA has granted orphan drug designation for Faron Pharmaceuticals’ lead candidate bexmarilimab to treat myelodysplastic syndrome. A company announcement says bexmarilimab is an investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function and igniting the immune system. It is said to
Biologics
FDA has accepted for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis (LN). The agency has set a user fee review action target date of 10/2025. The submission is based on data from the Phase 3 REGENCY trial. “The study demonstrated a statistically significant and clinically
FDA Policy/General
Ohio State University researchers say generic drugs made in India are linked to a significantly higher number of adverse events, including hospitalizations and deaths, than their counterparts that are made in the U.S. SciTechDaily reports online that the study was published in the journal Production and Operations Management. The
FDA Policy/General
FDA has placed a clinical hold on BioNTech’s Phase 1/2a dose escalation clinical trial (NCT06069544) evaluating the safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for preventing P. falciparum malaria in healthy malaria-naive adults. The company says the trial is being paused while
Drugs
FDA has approved an ARS Pharmaceuticals supplemental NDA for Neffy (epinephrine nasal spray 1mg) for treating Type I allergic reactions, including anaphylaxis, in children who are aged four years and older and weigh 15 to 30 kg. Previously, the product was approved for adult and pediatric patients who weigh at
Drugs
An 8/26-9/6/2024 FDA inspection at the Granules India Limited drug manufacturing facility in Gagillapur Village, Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/26 Warning Letter says the specific violations were: * failure to establish and follow adequate
Devices
AdvaMed says FDA should clarify in its draft guidance on protocol deviations for clinical investigations of drugs, biological products, and medical devices that derived deviations may be used in FDA reporting of protocol deviations. In a comment letter, the trade group also suggests defining key terms at the beginning of
FDA Policy/General
In a 2/24 ethics letter submitted to the HHS associate general counsel for ethics, FDA commissioner nominee Martin Makary says he will resign his position at Johns Hopkins University upon his confirmation as commissioner and will divest his many equity and non-equity holdings. The letter says that when
FDA Policy/General
A 9/17-9/20/2024 FDA inspection at the Chem-Tech drug manufacturing facility in Pleasantville, IA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/11 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
FDA Policy/General
FDA has accepted for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treating patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. The agency has set a user fee review action target date of 8/31. The submission is based on existing cardiac data from the company’
Biologics
FDA has approved a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgen’s Prolia, and Osenvelt (denosumab-bmwo), a biosimilar to Amgen’s Xgeva. The approval covers all indications of the reference products. Approval is based on “robust clinical evidence,” including data from Phase 3 clinical trials in
FDA Policy/General
“Dozens” of annual reports sent by drug companies to the Securities and Exchange Commission (SEC) warn of the impact of FDA staff and resource cuts, according to an online Wired post. The post says that Xenon Pharmaceuticals told the SEC the Trump administration “has enacted several executive actions that could
EIRs/483s
Elon Musk’s Department of Government Efficiency (DOGE) is claiming that it terminated the leases of 30 FDA field offices and laboratories throughout the U.S. The largest is a laboratory facility in St. Louis, MO, a 51,963 sq. ft. field office and laboratory that costs about $2.5
Devices
FDA has cleared a Damae Medical 510(k) for its deepLive, described by the company as an artificial intelligence-based imaging tool that provides real-time, three-dimensional visualization of the skin. The clearance is based on data from three years of clinical experience with the device and its intuitive
FDA Policy/General
CDER's Office of Prescription Drug Promotion (OPDP) has cited Edenbridge Pharmaceuticals over promotional materials used at a medical meeting exhibit booth because they made “false or misleading claims and representations about the risks and benefits of Hemady,” according to a just-posted untitled letter. “These violations are concerning
Drugs
FDA has accepted for review a Corcept Therapeutics NDA for its selective cortisol modulator relacorilant and its use in treating patients with endogenous hypercortisolism (Cushing’s syndrome). The agency has set a 12/30 user fee review action target date. The submission is based on data from the company’s