(A) TβR I mRNA expression was determined by real-time PCR in kidneys from P311+/+ (n = 6) and P311−/− (n = 6) after mice 7 days after UUO or sham operation. (B) TβR II mRNA expression was determined by real-time PCR in kidneys from P311+/+ (n = 6) and P311−/− (n = 6) mice 7 days after UUO or sham operation. (C) p-Smad2, p-Smad3, Smad2, Smad3, Smad4, Smad7 and GAPDH protein levels were determined in kidneys by western blot. (D) Relative density of Smad2 protein (n = 3 per group) in each treatment group. (E) Relative density of Smad3 protein (n = 3 per group) in each treatment group. (F) Relative density of p-Smad2 protein (n = 3 per group) in each treatment group. (G) Relative density of p-Smad3 protein (n = 3 per group) in each treatment group. (H) Relative density of Smad4 protein (n = 3 per group) in each treatment group. (I) Relative density of Smad7 protein (n = 3 per group) in each treatment group. A-I are representative of at least three similar experiments. Data are presented as the mean ± SD. *P < 0.05; **P < 0.01.
Accentia Biopharmaceuticals, Inc. (OTCPK:ABPI) is committed to building significant value for its stockholders through the commercialization of patent-protected disruptive healthcare technologies designed to be positioned as leading products for the treatment of a broad range of chronic, debilitating and life-threatening diseases including respiratory, autoimmune and cancer indications. Accentia is advancing a portfolio of potential blockbuster drug candidates which target multi-billion dollar market opportunities. These late-stage products include: BiovaxID®, a novel anti-idiotype cancer vaccine for the treatment of B-cell malignancies including indolent follicular non-Hodgkin’s lymphoma; Revimmune™, a novel ultra-high-dose formulation of a previously approved chemotherapeutic agent expected to show utility in the treatment of up to 80 autoimmune diseases, with an initial focus on multiple sclerosis; and SinuNase™, a novel formulation of a previously approved anti-fungal for the topical, intranasal treatment of chronic sinusitis. Accentia’s interest in BiovaxID is based on its majority ownership stake in Biovest International, Inc., and Accentia also maintains a royalty interest in Biovest’s biologic products.
We had negative cash flow from investing activities of approximately $60.0 million for the year ended December 31, 2018 as compared to a positive cash flow from investing activities of approximately $6.4 million for the year ended December 31, 2017. The negative cash flow from investing activities for the year ended December 31, 2018 was mainly due to investment in marketable debt securities in the amount of approximately $92.3 million, offset by maturity of marketable debt securities in the amount of approximately $38.4 million.
We, and any future collaborators, are not permitted to commercialize, market, promote or sell any product candidate in the U.S. without obtaining marketing approval from the FDA. Foreign regulatory authorities, such as the EMA, impose similar requirements. We have not previously submitted an NDA to the FDA or similar drug approval filings to comparable foreign regulatory authorities for any of our product candidates. We, and any future collaborators, must complete extensive pre-clinical development and clinical trials to demonstrate the safety and efficacy of our product candidates in humans before we will be able to obtain these approvals.
Generally, information reporting requirements will apply to distributions on our ordinary shares or proceeds on the disposition of our ordinary shares paid within the United States (and, in certain cases, outside the United States) to U.S. Holders other than certain exempt recipients, such as corporations. Furthermore, backup withholding (currently at 24%) may apply to such amounts if the U.S. Holder fails to (i) provide a correct taxpayer identification number, (ii) report interest and dividends required to be shown on its U.S. federal income tax return, or (iii) make other appropriate certifications in the required manner. U.S. Holders who are required to establish their exempt status generally must provide such certification on IRS Form W-9.
“Doesn’t the FDA have to approve all changes to manufacturing before the product can be sold?” – I don’t know the current regs, but back in the late 1980s, the FDA approved a change in Showa Denko’s synthesis and purification of L-tryptophan (sold as a nutriceutical) without a lot of investigation or testing. S-D had a long successful history making and selling T, so the FDA took their word for it.
Dragan, S., Serban, M. C. & Banach, M. Proprotein Convertase Subtilisin/Kexin 9 Inhibitors: An Emerging Lipid-Lowering Therapy? Journal of cardiovascular pharmacology and therapeutics , doi: 10.1177/1074248414539562 (2014).
We are planning to initiate the ARMOR Study, a Phase 3/4 pivotal study of Aramchol for the treatment of NASH at the end of the second quarter of 2019 or early in the third quarter of 2019, subject to a successful end of Phase 2b meeting and the FDA and other regulatory authorities agreeing with our IND or foreign equivalent, as applicable. The study design takes into consideration draft guidance issued by the FDA in December 2018 entitled “Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment”, or the “December Guidance”.
held End-of-Phase 2 discussions with the U.S. Food and Drug Administration, or FDA, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, or the U.K., or MHRA, and Health Canada. Based on FDA feedback, as well as advice provided by MHRA and Health Canada, we announced the design of a single-arm Phase 3 study in treatment-naïve PNH patients. In January 2019, we concluded scientific advice and protocol design discussions with the European Medicines Agency (EMA). The EMA was not receptive to a single-arm study design to support approval of zilucoplan in PNH. We do not plan to alter the design of the Phase 3 PNH program, but are reassessing the likelihood of obtaining marketing authorization for PNH in the European Union, or E.U.
Our executive offices are located in Tel Aviv, Israel. In addition, the majority of our officers and directors are residents of Israel. Accordingly, political, economic and military conditions in Israel may directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its neighboring countries. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations. In recent years, these have included hostilities between Israel and Hezbollah in Lebanon and Hamas in the Gaza strip, both of which resulted in rockets being fired into Israel, causing casualties and disruption of economic activities. In addition, Israel faces threats from more distant neighbors, in particular, Iran.
“If Zhejiang Huahai did not identify the need to develop a control strategy to reduce the new risks introduced with the optimized process, neither did regulators when they approved the process change,” he says, “and the manufacturer’s failure in this regard was just part of an industry-wide failure led by the regulators.”
Chamorro-Jorganes, A. et al. MicroRNA-16 and microRNA-424 regulate cell-autonomous angiogenic functions in endothelial cells via targeting vascular endothelial growth factor receptor-2 and fibroblast growth factor receptor-1. Arterioscler. Thromb. Vasc. Biol. 31, 2595–2606 (2011).
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