Applications in respect of a generic medicinal product cannot be made before the expiry of the protection period. Where the reference product was granted a national marketing authorization pursuant to an application made before October 30, 2005, the protection period is either six years or 10 years, depending upon the election of the particular member state concerned. Where the reference product was granted a marketing authorization centrally, pursuant to an application made before November 20, 2005, the protection period is 10 years. For applications made after these dates, Regulation 726/2004 and amendments to Directive 2001/83/EC provide for a harmonized protection period regardless of the approval route utilized. The harmonized protection period is in total 10 years, including eight years of research data protection and two years of marketing protection. The effect is that the originator’s results can be the subject of a cross-referral application after eight years, but any resulting authorization cannot be exploited for a further two years. The rationale of this procedure is that the relevant particulars can, if the research data protection period has expired, be found on the originator’s file and used for assessment of the generic medicinal product. The 10-year protection period can be extended to 11 years where, in the first eight years post-authorization, the holder of the authorization obtains approval for a new indication assessed as offering a significant clinical benefit in comparison with existing products.
Genitope Corp. ( OTCPK:GTOP ) is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Immunotherapy products are designed to utilize the immune system to combat diseases such as cancer. Our lead product candidate MyVax® Personalized Immunotherapy previously referred to as GTOP-99) is currently in a pivotal Phase 3 trial for the treatment of follicular non-Hodgkin’s lymphoma (f-NHL) Genitope was founded in 1996 by Dan W. Denney, Jr., Ph.D., after he developed our Hi-GET® technology, an important part of our proprietary manufacturing process, which is designed to rapidly and efficiently produce our immunotherapies. In addition to our pivotal Phase 3 trial, Genitope has also conducted several Phase 2 trials to study MyVax® Personalized Immunotherapy in B-cell non-Hodgkin’s lymphoma, or B-cell NHL. B-cell NHL represents approximately 85% to 90% of the 300,000 existing and 55,000 newly diagnosed NHL patients each year in the United States. Genitope Corporation intends to manufacture commercial quantities of MyVax® Personalized Immunotherapy and establish a sales force to market the product after receiving regulatory approval. We hold two U.S. patents covering our core gene amplification technology, including composition of matter claims directed to cell lines and claims directed to methods of making proteins derived from patients’ tumors. Corresponding patents have been issued in Australia and South Africa. Genitope has also filed additional U.S. and corresponding foreign patent applications relating to its Hi-GET® technology featuring high-throughput gene expression techniques.
HIF-mediated hypoxic response in PASMC is associated with increased proliferation, migration and decreased apoptosis. Acutely, such adaptive responses to hypoxia are beneficial in preserving normal cellular function. However, long-term hypoxia ultimately leads to induction of molecular events that result in pulmonary arterial remodeling and increased pulmonary arterial pressures27. Proliferation and migration of PASMC is an essential feature of vascular remodeling in hypoxia-induced pulmonary hypertension. Our data show that miR-322 promotes the proliferation and migration of rat PASMCs both under normoxia and hypoxia. Furthermore, Ghosh et al.23 and Chamorro-Jorganes et al.28 have demonstrated that human miR-424 significantly increases migration and proliferation of endothelial cells and plays a positive role in post-ischemic vascular remodeling and angiogenesis. However, a recent study by Kim et al. reported in studies using pulmonary arterial endothelial cells from patients of idiopathic PAH and heritable PAH that endothelial APLN-mediated regulation of miR-424 that may have an anti-angiogenic function. Further studies are still needed to provide greater insights into the function and mechanism of this critical miRNA.
What began as a single case has snowballed into a major risk-assessment puzzle. The European Medicines Agency (EMA) is considering not only valsartan and losartan, but candesartan, irbesartan, and olmesartan in its efforts to find root cause (7). Both FDA and the General European Official Medicines Control Laboratories Network (GEON) published methods
We will need to significantly increase the size of our organization, and we may experience difficulties in managing growth.
If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this annual report in greater detail under the heading “Risk Factors” and elsewhere in this annual report. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events.
The principal competitors for our program in PNH are eculizumab and ravulizumab-cwvz, both of which are monoclonal antibody C5 inhibitors marketed by Alexion Pharmaceuticals. In addition, we are aware that there are a number of other companies that are actively developing product candidates for the treatment of PNH. These include product candidates directed at C5 inhibition such as Coversin, a small protein inhibitor of C5 in clinical development by Akari Pharmaceuticals; ABP 959, a biosimilar product candidate in clinical development by Amgen; tesidolumab, a monoclonal antibody inhibitor of C5 in clinical development by MorphoSys AG and Novartis Pharmaceuticals; pozelimab, a monoclonal antibody inhibitor of C5 in clinical development by Regeneron Pharmaceuticals; and RG6107, a monoclonal antibody inhibitor of C5 in clinical development by F. Hoffmann La Roche. In addition, competitors include product candidates directed at C3 inhibition, such as APL 2, currently in clinical development by Apellis Pharmaceuticals, and AMY-101, currently in clinical development by Amyndas Pharmaceuticals. Lastly, we face competition from orally available small molecule inhibitors of Factor D, such as ACH 4471, in clinical development by Achillion Pharmaceuticals, and LNP023, a Factor B inhibitor in clinical development by Novartis.
It hangs together nicely with the idea that being in an energy deficit state makes the body last longer.
We are an emerging growth company within the meaning of the rules under the Securities Act and we will utilize certain exemptions from various reporting requirements that are applicable to public companies that are not emerging growth companies. We could remain an “emerging growth company” for up to five years from the date of our first sale of common equity securities pursuant to an effective registration statement under the Securities Act (i.e. December 31, 2019), or until the earliest of (a) the last day of the first fiscal year in which our annual gross revenue exceeds $1.07 billion (as such amount is indexed for inflation every five years by the SEC to reflect the change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics, setting the threshold to the nearest $1.0 million) or more, (b) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our ordinary shares that is held by non-affiliates exceeds $700.0 million as of the last business day of our most recently completed second fiscal quarter, or (c) the date on which we have issued more than $1 billion in nonconvertible debt during the preceding three year period.
To understand the consequences of increased miR-322 in hypoxia, we investigated the effects of miR-322 overexpression and knockdown on the proliferation and migration in rat PASMCs. As shown in Fig. 5a, stable overexpression of miR-322 significantly accelerated the proliferation rate of PASMCs compared to its control cells both under normoxia and hypoxia by MTS assay. EdU incorporation assay, a specific assay that labels replicating cells, also showed higher fraction of proliferating cells in miR-322-expressing cells compared with control cells (Fig. 5b). FACS analysis of PI-stained cells indicated that the proportion of cells in S and G2/M phase was significantly increased, and cells in G1 phase decreased by a comparable degree (Fig. 5c). To further confirm these results, we performed the proliferation assay in PASMCs after miRNA knockdown. In contrast with miRNA overexpression studies, proliferation was significantly reduced in anti-322 transfected cells compared to that of control cells, both when exposed to normoxia or hypoxia (Fig. 5d,e,f). These data indicate that miR-322 can significantly accelerate the proliferation of PASMCs.
There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved drugs. Marketing approvals, pricing and reimbursement for new drug products vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we, or any future collaborators, might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability or the ability of any future collaborators to recoup our or their investment in one or more product candidates, even if our product candidates obtain marketing approval.
After Valsartan Recalls, Regulators Grapple with Nitrosamine Contamination in APIs | Synthetic Angiotensin Ii Gmp Provider From China Related Video:
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