I agree that we were just speculating. On my side, it is based on nothing. It is not science at all (again on my side). Just having fun. Maybe we should not do that here. I’ll try to be more careful.
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Dewachter, L. et al. Bone morphogenetic protein signalling in heritable versus idiopathic pulmonary hypertension. Eur. Respir. J. 34, 1100–1110 (2009).
William Marth, a director of the Company since March 2014. Since April 2018, Mr. Marth has served as the President and Chief Executive Officer of North America and Europe for Heritage Pharma Holdings Inc., a wholly owned subsidiary of Emcure Pharmaceuticals Ltd. Mr. Marth previously served as President and Chief Executive Officer of Albany Molecular Research Inc. since January 2014 until January 2018. Previously, Mr. Marth served as a Director of Albany Molecular Research Inc. and as chairman of its board of directors from June to December 2013. Prior to this, he served as President and Chief Executive Officer of Teva Pharmaceutical Industries Ltd. in the Americas from June 2010 to November 2012 and Chief Executive Officer of Teva North America from January 2008 to June 2010 and CEO of Teva USA from January 2005 to January 2008. In addition, Mr. Marth worked with several large equity firms providing guidance on their healthcare investments. He was a member of Teva’s global executive management team from 2007 to 2012. From July 1999 to January 2002, he was the Executive Vice President and Vice President of Sales and Marketing for Teva USA. Prior to joining Teva USA, he held various positions with the Apothecon division of Bristol-Myers Squibb. Mr. Marth is a pharmacist and is currently a director at the University of Illinois at Chicago College of Pharmacy (UIC). Previously, Mr. Marth served as the Chairman of the Board of Directors of Sorrento Therapeutics from 2014 to July 2017, the Chairman of the Board of the Generic Pharmaceutical Association (GPhA) in 2008 and 2009 and the American Society for Health-System Pharmacists (ASHP) in 2010, and various boards and committees, including the University of the Sciences in Philadelphia and the Board of Ambassadors for John Hopkins’ Project RESTORE. Mr. Marth earned his B.Sc. in Pharmacy from the University of Illinois in 1977 and his M.B.A. in 1989 from the Keller Graduate School of Management, DeVry University.
Clinigen Group PLC (LSE:CLIN.L) is a specialty pharmaceuticals and services business company. The Company operates in three segments: Clinical Trial Supply, Specialty Pharmaceuticals and Global Access Programs. Clinical Trial Supply division is involved in the sourcing and supply of comparator products for Clinical Trials. Specialty Pharmaceuticals division is involved in the manufacture and distribution of pharmaceutical products. Global Access Programs division provides on-going access to patients involved in clinical trials through the management of Access Programs. The Company’s subsidiaries include Clinigen Healthcare Limited, Keats Healthcare Limited, Clinigen CTS Inc, Clinigen Pharma Limited, Clinigen Clinical Trials Limited, Clinigen CTS Limited and Clinigen GAP Limited. In March 2013, the Company announced the acquisition of Cardioxane (dexrazoxane).
According to published guidance on the SPA process, a sponsor which meets the prerequisites may make a specific request for an SPA and provide information regarding the design and size of the proposed clinical trial. The FDA has a goal of completing the majority of SPA reviews within 45 days, although certain circumstances may result in a delay in FDA’s decision. An SPA request must be made before the proposed trial begins, and all open issues must be resolved before the trial begins. If a written agreement is reached, it will be documented and made part of the record. The agreement will be binding on the FDA and may not be changed by the sponsor or the FDA after the trial begins except with the written agreement of the sponsor and the FDA or if the FDA determines that a substantial scientific issue essential to determining the safety or efficacy of the drug was identified after the testing began. There is no indication that we will be able to meet the requirements necessary for a SPA.
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.
Elite Pharmaceutical, Inc. (OTCBB:ELTP) develops oral sustained and controlled release products. Elite’s strategy includes assisting partner companies in the life cycle management of products, to improve off-patent drug products, and developing generic versions of controlled release drug products with high barriers to entry. Elite has four ANDA products partnered with TAGI Pharma; one ANDA has launched, two ANDAs are in the process of a manufacturing site transfer and an additional ANDA is currently under review by the FDA. Elite’s lead pipeline products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are novel sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also has partnered with Mikah Pharma to develop a new product and with Hi-Tech Pharmacal to develop an intermediate for a generic product. Elite also performs contract manufacturing services. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
Goch, A., Banach, M., Mikhailidis, D. P., Rysz, J. & Goch, J. H. Endothelial dysfunction in patients with noncomplicated and complicated hypertension. Clinical and experimental hypertension 31, 20–30, doi: 10.1080/10641960802409846 (2009).
As a precaution, to ensure that synthesis process changes or other factors have not resulted in systemic contamination of sartan drugs now on the market, the European Medicines Agency (EMA) will now expand its review of nitrosamine impurities to include four other widely-prescribed active ingredients:
We believe that we qualify as an “Industrial Company” within the meaning of the Industry Encouragement Law. There can be no assurance that we will continue to qualify as an Industrial Company in the future or that the benefits described above will be available to us at all.
Outside the U.S., ensuring adequate coverage and payment for our product candidates will face challenges. Pricing of prescription pharmaceuticals is subject to governmental control in many countries. Pricing negotiations with governmental authorities can extend well beyond the receipt of regulatory marketing approval for a product and may require us to conduct a clinical trial that compares the cost effectiveness of our product candidates or products to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in our commercialization efforts.
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