The merging of medical products: Enhancing review of therapeutic and diagnostic combination products

By: Robert M. Califf, M.D. and Jill Hartzler Warner, J.D. Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority. Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas.These products, that combine drugs, devices, and/or biological product (“constituent parts”) with one another, come in three configurations. The constituent parts may be physically or chemically combined, co-packaged, or separately distributed with specific labeling for their combined use. Combination products pose unique challenges – both because they may involve new, complex technologies – and because their review at FDA often involves the expertise of more than one Center. While review of such products falls to a cross-center team of experts, it is led by the medical product Center responsible for the constituent part that provides the product’s primary mode of action, which, in the case of a syringe prefilled with a drug, for example, would be FDA’s Center for Drug Evaluat...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog FDA Source Type: news

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Authors: Buck E, Sprick M, Gaida MM, Grüllich C, Weber TF, Herpel E, Bruckner T, Koschny R Abstract Recently, a tumor-autonomous cytochrome P450 (CYP)-3A5-mediated resistance to cancer therapy has been demonstrated in pancreatic ductal adenocarcinoma. Expression of CYP3A5, which is involved in the degradation of irinotecan, has also been reported in colorectal cancer (CRC). The aim of the present study was to analyze CYP3A5 expression in the normal colon, colon adenoma, CRC and normal tissues, as well as to examine whether CYP3A5 expression in CRC has an impact on tumor response to irinotecan treatment. Immuno...
Source: Oncology Letters - Category: Cancer & Oncology Tags: Oncol Lett Source Type: research
ConclusionsH-Zt/g4-MMAE is superior in eradication of pancreatic cancer xenografts with favorable pharmacokinetic profiles and manageable toxicological activities. These findings warrant the transition of H-Zt/g4-MMAE into clinical trials in the future.
Source: Journal for Immunotherapy of Cancer - Category: Cancer & Oncology Source Type: research
Abstract SRC and its activated form, phospho-SRC (pSRC), are aberrantly activated in pancreatic cancer and SRC represents a potential target for pancreatic cancer therapy. In this paper, we examined the inhibitory effect of dasatinib, a potent SRC inhibitor in combination with paclitaxel or gemcitabine on human and murine pancreatic cancer cell lines. The results showed that p-SRC can be highly expressed in most human and mouse pancreatic cancer cell lines compared with normal human cell lines and can be induced by paclitaxel or gemcitabine in HPAC cells. Dasatinib can enhance the efficacy of paclitaxel or gemcita...
Source: Cancer Biology and Therapy - Category: Cancer & Oncology Authors: Tags: Cancer Biol Ther Source Type: research
In conclusion, GA micelles which showed high-efficiency anti-tumor effect in vitro and in vivo may serve as a candidate for pancreatic cancer therapyGraphical abstractMonomethyl poly(ethylene glycol)-poly(ε-caprolactone)-poly(trimethylene carbonate) (MPEG-P(CL-ran-TMC)) copolymer was synthesized, which could encapsulate GA by a single-step solid dispersion and form nano-sized micelles. The MPEG-P(CL-ran-TMC) based nano-formulation of GA could improve the anti-tumor effect in vivo, which may serve as a candidate for pancreatic cancer therapy.
Source: Chinese Chemical Letters - Category: Chemistry Source Type: research
Publication date: Available online 27 February 2019Source: International Journal of PharmaceuticsAuthor(s): Cenk Daglioglu, Fatma Necmiye KaciAbstractChemotherapy frequently involves combination treatment protocols to maximize tumor cell killing. Unfortunately these intensive chemotherapeutic regimes, often show disappointing results due to the development of drug resistance and higher nonspecific toxicity on normal tissues. In cancer treatment, it is critically important to minimize toxicity while preserving efficacy. We have previously addressed this issue and proposed a nanoparticle-based combination therapy involving b...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research
About half of all Americans are cremated when they die. So when a 69-year-old man was cremated in Arizona in 2017, it didn’t seem out of the ordinary — until doctors learned that his body may have put others at risk of radiation exposure. In 2017, the man was admitted to a hospital for low blood pressure treatment, according to a new research letter published in JAMA. But unbeknownst to his doctors, the man had been treated at the Mayo Clinic Arizona just the day before, where he had been injected with lutetium 177, a radiopharmaceutical used to combat his pancreatic cancer. When the man died two days after bei...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized healthytime medicine Source Type: news
tis CA Abstract Pancreatic ductal adenocarcinoma (PDA) is characterized by abundant infiltration of tumor-associated macrophages (TAMs). TAMs have been reported to drive resistance to gemcitabine, a frontline chemotherapy in PDA, though the mechanism of this resistance remains unclear. Profiling metabolite exchange, we demonstrate that macrophages programmed by PDA cells release a spectrum of pyrimidine species. These include deoxycytidine, which inhibits gemcitabine through molecular competition at the level of drug uptake and metabolism. Accordingly, genetic or pharmacological depletion of TA...
Source: Cell Metabolism - Category: Cytology Authors: Tags: Cell Metab Source Type: research
DTLP showed bispecific binding activities to EGFR/HER ‐2 in vitro and in vivo. DTLL showed potent anti‐pancreatic cancer efficacy in CDX and PDX mouse models of human pancreatic cancer 3. DTLL had an antineoplastic effect by inhibited AKT/mTOR and PD‐1/PD‐L1 signal pathways in human pancreatic cancer. AbstractPancreatic ductal adenocarcinoma (PDAC) is a refractory malignant tumor with poor prognosis, limited chemotherapeutic efficacy, and only about 5% of 5 ‐year survival rate. We generated a dual‐targeting ligand‐based lidamycin (DTLL) to investigate its efficacy against pancreatic cancer after preparing its...
Source: Cancer Medicine - Category: Cancer & Oncology Authors: Tags: ORIGINAL RESEARCH Source Type: research
This study showed that potential vicious cycles underlying ARDs are quite diverse and unique, triggered by diverse and unique factors that do not usually progress with age, thus casting doubts on the possibility of discovering the single molecular cause of aging and developing the single anti-aging pill. Rather, each disease appears to require an individual approach. However, it still cannot be excluded that some or all of these cycles are triggered by fundamental processes of aging, such as chronic inflammation or accumulation of senescent cells. Nevertheless, experimental data showing clear cause and effect relationships...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
ConclusionTFAE have anti-tumor activity against pancreatic cancer and can induce apoptosis and autophagy through PI3K/Akt/mTOR signal pathway. TFAE might be a potential anticancer drug to be further developed for human pancreatic cancer therapy.Graphical abstract
Source: Journal of Ethnopharmacology - Category: Drugs & Pharmacology Source Type: research
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