Biologics
FDA has issued Alvotech a complete response letter on its BLA for AVT05, a biosimilar to Janssen Pharmaceuticals’ Simponi (golimumab), in both prefilled syringe and autoinjector formats. The letter cited deficiencies identified during a July pre-license inspection of Alvotech’s Reykjavik manufacturing facility, according to the company. Alvotech says
Biologics
Gene therapy company uniQure says that FDA indicated during a recent pre-BLA meeting that the agency may no longer view the company’s Phase 1-2 data for its Huntington’s disease (HD) therapy AMT-130, analyzed against an external control, as sufficient to serve as primary evidence to
Drugs
FDA is preparing to introduce a new, accelerated pathway for approving custom gene-editing therapies, aimed at treating patients with rare diseases. The announcement, highlighted in an interview with CBER director Vinay Prasad, signals a major shift in the agency’s regulatory approach. Prasad told Bloomberg News that advances in
Drugs
FDA is announcing new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs. The agency sent notices to four companies signaling its intent to take enforcement action against products marketed for children under age three, or for older children at low to moderate risk of tooth decay, according
Biologics
FDA has granted interchangeability designations to Celltrion’s denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), making them fully substitutable at the pharmacy level for Amgen’s reference biologics Prolia and Xgeva, respectively. The action marks the first time interchangeable status has been awarded to biosimilar versions of denosumab,
Devices
FDA has issued an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ankle Replacement system continues to demonstrate a higher-than-expected risk of device failure, with revision rates increasing significantly over 10 years of follow-up. According to a final post-
Drugs
Eli Lilly says its investigational weight-loss pill met most criteria for FDA’s new national priority voucher program, suggesting it is a strong candidate for a significantly accelerated approval review. The company says it will submit before the end of the year an NDA for orforglipron, and the agency
Biologics
Johnson & Johnson has submitted a supplemental BLA seeking to expand the use of its biologic therapy Stelara (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis (UC). The filing is based on data from the Phase 3 UNIFI Jr study, which evaluated
Drugs
A Friends of Cancer Research working group on determining a standard of care (SOC) comparator in multi-regional oncology trials says that while perfect solutions may not be attainable, “a thoughtful and ongoing process can improve applicability and transparency in comparator selection, ensuring trials remain feasible, meaningful, and representative across
Drugs
FDA has released the form FDA-483 issued following an 8/4-8/13 inspection at the Zydus Lifesciences drug manufacturing facility in Baddi, Himachal, Pradesh, India. The inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * procedures describing the handling of
Biologics
FDA has issued a clinical hold on Intellia Therapeutics’ MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nexiguran ziclumeran (nex-z) after the company disclosed Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nex-z in the MAGNITUDE trial. The company earlier this
Drugs
FDA has granted Dewpoint Therapeutics an orphan drug designation for DPTX3186, a first-in-class condensate modulator being developed to treat gastric cancer. The designation comes on the heels of the agency’s recent acceptance of Dewpoint’s IND to launch the first in-human study of a condensate-modulating
Devices
FDA has cleared a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer, the HLC-723 GR01, for rapid and precise HbA1c (blood sugar) testing. The new system can deliver results in as little as 50 seconds, supporting both diabetes diagnosis and long-term glucose monitoring, according to
Drugs
FDA has accepted for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotreotide injection, indicated for use with positron emission tomography imaging for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients. Submitted under FDA’
Drugs
Senate Special Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) have asked three group purchasing organizations (GPOs) for information on vulnerabilities in the U.S. pharmaceutical supply chain involving generic drugs made overseas. In a statement (contains a link to the letter sent
Drugs
Speaking at the 10/27 Biotechnology Innovation Organization’s Patient Advocacy Changemaker’s Event, new CDER director George Tidmarsh said his immediate goals are to improve staff morale, hire additional reviewers, and reduce the number of Investigational New Drug (IND) applications by reforming the process. Tidmarsh told attendees that FDA
Drugs
FDA has granted a fast-track designation for Alphamab Oncology’s biparatopic HER2-targeting antibody drug conjugate JSKN003 to treat advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted by HER2 expression. A company statement says the designation follows FDA approval
Drugs
A U.S. District Court in Hawaii ruled 10/20 that FDA acted unlawfully by imposing certain restrictions on mifepristone. The court found the FDA failed to provide a reasoned explanation for its restrictive regulation of the medication. The case centered on an agency-mandated Risk Evaluation and Mitigation Strategy
Devices
A 6/30-7/3 FDA inspection at Qinjiang Kingphar Medical Material Co. in Qinjiang, China, identified two Quality System Regulation violations in the firm’s manufacturing of surgical masks, wound dressings, sterilization wraps, and surgical drapes. A 10/3 Warning Letter says the specific violations were: * failure to establish
Drugs
Reporting on the FDA 9/30 public meeting on onshoring manufacturing of drugs and biological products, attorneys Mark Schwartz and Julie Kim (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that if the agency can rapidly implement a PreCheck program that formalizes early, durable engagement; modernizes
Devices
A 6/9-6/12 FDA inspection at Centec Medical Systems in Qinhuangdao, China, found Quality System Regulation and other violations in its production of several medical devices. A 10/2 Warning Letter says the specific violations were: * failure to adequately establish procedures for corrective and preventive action; * failure to
Biologics
FDA Office of Therapeutic Biologics and Biosimilars (OTBB) director Sarah Yim said the agency is focused on making biosimilar development faster and more predictable — without undermining scientific rigor. Referencing recent analyses on rising development costs, Yim warned: “If biosimilar development becomes too costly, that’s a problem,” and stressed a