Drugs
Novartis’ Advanced Accelerator Applications is asking FDA to impose restrictions on ANDAs or 505(b)(2) NDAs that reference and rely on Novartis’ Lutathera (lutetium Lu 177 dotatate) for approval. The petition asks FDA to ensure that any applicants demonstrate that their product contains the same amount of the active
Drugs
A two-week December FDA inspection of Sun Pharmaceutical Industries’ Dadra, Dadra & Nagar Haveli and Daman, India facilities led to a six-observation FDA Form-483 that has cited the firm for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Devices
FDA says it has learned that Soulaire Corp. in Santa Monica, CA, is marketing an external counter-pulsating device in the U.S. without marketing clearance or approval. A just-released 1/29 Warning Letter says the device is intended to treat chronic stable angina that is refractory to optimal
Drugs
A 10/9-10/18/2023 FDA inspection at the Natco Pharma drug manufacturing facility in Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/8 Warning Letter says specific violations were: * failing to clean, maintain, and, as appropriate for the nature
FDA Policy/General
Federal Register notice: FDA is announcing the establishment of CDER’s Center for Clinical Trial Innovation, which is intended to be a central hub to support innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision-making. Its mission is
Devices
Former Decision Diagnostics CEO Keith Berman has been sentenced to seven years in prison for a securities fraud scheme involving a Covid-targeting medical device that he claimed was on the verge of being approved by FDA, but in reality did not exist. The scheme resulted in about $28 million
Drugs
FDA has issued a safety alert on unsafe counterfeit versions of AbbVie’s Botox (botulinum toxin) have been found in multiple states and administered to consumers for cosmetic purposes. “FDA is aware of adverse events, including hospitalizations, linked to the counterfeit Botox. Symptoms included blurred or double vision, difficulty swallowing,
Devices
FDA has approved an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation. The “capacitively coupled” device emits a low-energy signal that has been clinically proven to promote bone healing after spinal fusion surgery, according to the company. It is designed to prioritize patient ease of
Drugs
FDA is expanding its partnership with the Lupus Research Alliance (LRA) by including CBER in the Lupus Accelerating Breakthroughs Consortium (Lupus ABC). LRA says the addition of CBER to Lupus ABC “will enhance the consortium’s focus on engineered cell therapies, a promising new area in therapeutic development.” Lupus ABC
Drugs
An 11/6-11/10/2023 FDA inspection at the C&T Dream Co. drug manufacturing facility in Cheonan-si, South Korea, identified repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/11 Warning Letter says specific violations were: * failing to conduct at
Devices
CDRH says it has launched a new public dataset to help chemistry labs ensure the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. A statement from CDRH director Jeffrey Shuren says the dataset “will allow analytical chemistry labs to determine their ability to detect a
Biologics
FDA has accepted for review a GSK BLA for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The user fee review action target date is 2/14/2025. The vaccine combines the antigenic components of the company’s two established meningococcal vaccines — Bexsero (meningococcal Group B vaccine) and Menveo
Drugs
FDA has placed a clinical hold on a Neumora Therapeutics Phase 1 clinical trial for NMRA-266 for treating brain diseases. NMRA-266 is described as a positive allosteric modulator of the M4 muscarinic receptor. The hold follows recently reported pre-clinical data showing convulsions in rabbits. About 30 participants
Drugs
Novartis 4/15 reported favorable data from a pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study of Fabhalta (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN). According to the company, patients treated with Fabhalta achieved a 38.3%
Devices
FDA has cleared a 3D Systems 510(k) for its 3D-printed, patient-specific cranial implant VSP PEEK Cranial Implant, which is intended for cranioplasty procedures to restore defects in the skull. The device includes a “complete FDA-cleared workflow comprising segmentation and 3D modeling software, the 3D Systems EXT
Drugs
FDA issued Zydus Lifesciences a four-item Form FDA-483 after inspecting the firm’s manufacturing facility (Matoda, Gujarat, India). The form said Zydus’ aseptic processing areas are deficient, specifically its system for monitoring environmental conditions. For example, it said that from 5/23 to 12/2023 the firm manufactured
Drugs
FDA has granted Soligenix an orphan drug designation for the active ingredient in MarVax, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein for post-exposure prophylaxis against MARV infection. Marburg marburgvirus causes Marburg Virus Disease, a related disease to the Ebola virus disease, the company says. “Although
Devices
Abbott’s Thoratec unit is recalling (Class 1) its HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called extrinsic outflow graft obstruction. The condition occurs when “biological material builds up between the HeartMate outflow graft and the outflow graft bend relief or additional components
Drugs
CDER is announcing the launch of its Center for Clinical Trial Innovation (C3TI), which the Center says is intended to promote clinical trial innovation activities through enhanced communication and collaboration. C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve
Devices
Fresenius Kabi USA has recalled (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that have the potential to cause underdose, overdose, or a delay in therapy, which could lead to serious patient harm or death, according to an agency recall notice. The
Drugs
FDA has classified a 12/4/2023 to 12/15/2023 inspection at Sun Pharmaceutical Industries’ Dadra, India facility as “official action indicated.” The classification is the agency’s most severe and requires corrections and often a follow-up inspection. “We will work with the regulator to achieve fully compliant
Drugs
FDA’s Oncologic Drugs Advisory Committee 4/12 unanimously voted (12 to 0) that the totality of data are adequate to support the use of minimal residual disease (MRD) as an endpoint to support accelerated approval in multiple myeloma (MM) clinical trials. Two applicants — the University of Miami and 12TEAMM