Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.
From time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption.
激素治疗癌症最主要的优势是不会引起类似细胞毒物质一样的骨髓抑制。精确的抗癌机制不是完全清楚。最常用于治疗乳腺癌和前列腺癌,以及子宫内膜癌和子宫癌。此类药物包括:
Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.
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In order to explore the beneficial properties of boswellia serrata and the possible roles of eNOS-NO–cGMP pathway, it is hypothesized that β-BA can provide endothelium protection against vascular injury induced by blood stasis syndrome in rats and oxygen and glucose deprivation (OGD) in human umbilical vein endothelial cells (HUVECs).
Our business involves the controlled use, through our service providers, of hazardous materials, various biological compounds and chemicals, and as such, we, our agents and our service providers may be subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous, radioactive and biological materials and wastes and the cleanup of contaminated sites. The risk of accidental contamination or injury from these materials cannot be eliminated. If an accident, spill or release of any regulated chemicals or substances occurs, we could be held liable for resulting damages, including for investigation, remediation and monitoring of the contamination, including natural resource damages, the costs of which could be substantial. We may incur substantial capital costs and operating expenses and may be required to obtain consents to comply with any environmental and health laws or regulations and the terms and conditions of any permits required pursuant to such laws and regulations, including costs incurred by us to install new or updated pollution control equipment for our service providers, modify our operations or perform other corrective actions at our facilities or the facilities of our service providers. In addition, fines and penalties may be imposed on us, our agents and/or our service providers for noncompliance with environmental, health and safety and other laws and regulations or for the failure to have, or comply with the terms and conditions of, required environmental or other permits or consents.
If the scope of the patent protection we or our licensors obtain is not sufficiently broad, we may not be able to prevent others from developing and commercialize technology and products similar or identical to ours. The degree of patent protection we require to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any of our licensed patents have, or that any of our pending licensed patent applications that mature into issued patents will include, claims with a scope sufficient to protect our proprietary platform or otherwise provide any competitive advantage, nor can we assure you that our licenses are or will remain in force. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the U.S. Furthermore, patents have a limited lifespan. In the U.S., the natural expiration of a patent is generally twenty years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our
Investigation of continuous processing has not been limited to chemical syntheses. There has also been significant interest in developing continuous biocatalytic reactions, which are more complex and challenging to implement. German researchers reported the integration of microfluidic reactor technology with solid-liquid biocatalytic reactions (13). As a case study, they reported the biocatalytic conversion of styrene to (S)-styrene oxide using catalytic biofilms in a microreactor.
No offering expenses were paid directly or indirectly to any of our directors or officers, or their associates, or persons owning 10% or more of any class of our equity securities or to any other affiliates.
(a) TOF-SIMS images of BMSs cultured for 7 days. The spectrum was the high-resolution TOF-SIMS spectra. (b) Ca ion levels normalized to the C5H9 fragment showing that there is higher Ca level on PArN than PAr and blank. The field of view is 200 μm × 200 μm. The figures show the TOF-SIMS images representative of three repeated analyses. (c) Expression levels of osteogenic markers (Runx-2, ALP, OCN, and BSP) of BMSCs at day 3 by real time PCR relative to GAPDH expression and normalized to the expressions by cells cultured on blank, showing PArN promotes osteogenic expression of BMSCs. (d) Runx-2 and OCN protein products of the cells cultured at day 7 by western blot analysis relative to β-actin, revealing PArN increases osteogenic protein products of BMSCs. (*, p < 0.05) and (**, p < 0.01) denote statistical significance compared to blank group.
We initiated a Phase 2 clinical trial with zilucoplan for gMG in the fourth quarter of 2017. In August 2018, we announced the early completion of enrollment of 44 patients in our Phase 2 trial in gMG, surpassing our original enrollment target of 36 patients. In November 2018, we announced completion of dosing of all patients, and we reported top-line data in December 2018. Based on this top-line data, we plan to engage with regulatory agencies, including the FDA, in the first half of 2019 regarding the design of a Phase 3 clinical trial evaluating zilucoplan versus placebo in patients with gMG and expect to initiate the global Phase 3 clinical trial in the second half of 2019.
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