Drugs
FDA has released the 29-page form FDA-483 with 16 observations from a 5/1-5/12 inspection at an Intas Pharmaceuticals drug manufacturing facility in Ahmedabad, Gujarat, India. News accounts have cited the company as being involved in the current shortage of the oncology drug cisplatin. The specific
Drugs
FDA has issued Hemogenyx Pharmaceuticals a clinical hold on an IND for the company’s chimeric antigen receptor T-cells (CAR-T) therapy for treating acute myeloid leukemia. The company says the hold is related to a “splicing that occurs during the manufacturing process of the lentivirus that is used
Drugs
FDA has granted Theriva Biologics an orphan drug designation for VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus for treating pancreatic cancer. In the Phase 2b VIRAGE study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line
Drugs
Madrigal Pharmaceuticals has begun a rolling NDA submission seeking accelerated approval of resmetirom for treating nonalcoholic steatohepatitis with liver fibrosis. Madrigal says it has submitted the majority of the NDA and plans to submit the rest by 7/30. “In the MAESTRO-NASH biopsy trial, resmetirom achieved both liver histological
Drugs
A group of bipartisan House members are reintroducing the Promising Pathway Act that would provide a provisional approval pathway for promising drugs that treat life-threatening conditions. “Although other expedited pathways exist, this bill allows for more innovative clinical trials and encourages FDA review of applications on a rolling basis,
Drugs
A 6/30 Bloomberg editorial is calling for better FDA regulation and more transparency in dealing with generic drugs and active pharmaceutical ingredients coming from abroad. The editorial is critical of recent uncovered serious lapses in quality control at Indian pharmaceutical factories making generic drugs for U.S. consumers. “These
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FDA has published a guidance, Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment, to assist sponsors to develop drugs or biological products to treat chronic rhinosinusitis with nasal polyps (CRSwNP). The document discusses the agency’s current thinking about trial population and design, effectiveness, statistical analysis, and safety for
Drugs
The FDA Compounding Quality Center of Excellence has posted a Frequently Asked Questions document on compounding inspections and oversight. The document contains 14 questions and answers about agency inspections and enforcement actions.
Drugs
FDA has approved CellTrans’ Lantidra (donislecel), the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells to treat Type 1 diabetes. An agency announcement says Lantidra is approved to treat adults with Type 1 diabetes who are unable to approach targeted glycated hemoglobin due to current repeated
Drugs
FDA has released an 18-page form FDA-483 with 11 observations from a 6/5-6/13 inspection at Ipca Laboratories, an active pharmaceutical ingredient (API) manufacturer in Ratlam, Madhya Pradesh, India. The observations were: * investigations are inadequate to determine the root cause for the failure of a batch
Drugs
FDA has approved a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe hemophilia A without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an agency-approved test. Hemophilia A is a rare, genetic condition caused by a mutation in the gene
Drugs
Researchers from the FDA Oncology Center of Excellence, the American Association for Cancer Research (AACR), and five leading drug companies say that meeting the need of all cancer patients will require a major shift to prioritize participant diversity in the clinical development of oncology drugs. Writing in Clinical Cancer Research,
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FDA and National Cancer Institute researchers say the cancer treatment landscape has changed dramatically since 2000, resulting in substantial improvements in patient outcomes. Writing in Nature Reviews Drug Discovery, the researchers summarize trends in the approval of oncology therapeutic products by FDA from 1/2000 to 10/2022, based on
Drugs
Sens. Rick Scott (R-SC), J.D. Vance (R-OH) and Mike Braun (R-IN) are asking FDA for information on why the agency is allowing unapproved cancer drugs from China into the U.S. “rather than addressing the needs of older adults who are impacted by drug shortages.” In
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FDA has approved a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treating pediatric patients (three years of age and older) who have growth failure due to inadequate secretion of endogenous growth hormone. Approval is based on data from a
Drugs
FDA has issued Eton Pharmaceuticals a second complete response letter (CRL) on its NDA for dehydrated alcohol injection for treating methanol poisoning, citing chemistry manufacturing and controls issues. The company says all issues in the CRL are “addressable” and it will develop a comprehensive action plan to address the concerns.
Drugs
FDA has released the form FDA-483 issued following a 2/23-3/3 inspection at the Prisma Health outsourcing facility in Simpsonville, SC. The four inspection observations were: * failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are deficient in
Drugs
FDA says all drugs and drug products manufactured by Chengdu KeCheng Fine Chemicals in Chengdu Shi Sichuan Sheng, China, were placed on an Import Alert 6/8. A 6/20 Warning Letter says the action follows several company refusals to provide records and other information sought by the agency. Chengdu
Drugs
Eli Lilly says new Phase 2 data on weight-loss candidate retatrutide met primary and secondary endpoints. After 24 weeks, it met the primary endpoint by demonstrating a mean weight reduction up to 17.5% (41.2 lb. or 18.7 kg), the company says. In meeting the secondary endpoint,
Drugs
A 4/11-5/11/22 FDA inspection at the Safe Chain Solutions wholesale drug distribution facility in Cambridge, MD, found violations of the Drug Supply Chain Security Act (DSCSA). A 6/8 Warning Letter says FDA observed that the company did not have adequate verification systems in place, failed
Drugs
The FDA Oncology Center of Excellence (OCE) is working with the Reagan-Udall Foundation to evaluate essential data elements that could provide a starting point for characterizing the data sources and study design of an early real-world data study proposal. Writing in an FDA Voices online post, OCE associate
Drugs
Senate majority leader Chuck Schumer (D-NY) says Congress should approve a four-prong legislative solution to the growing nationwide problem of drug shortages. He also called on FDA to activate a plan to limit shortages. Speaking at a hospital in upstate New York, Schumer said, “I am not only