General and administrative expenses increased by $4.7 million to $14.5 million for the year ended December 31, 2018, from $9.8 million for the year ended December 31, 2017. This was primarily attributable to $1.7 million increase in compensation, benefits and other employee-related expenses due to 2018 salary increases and higher average headcount to support our increased activities; a $1.1 million

        Patients with MG present with muscle weakness that becomes increasingly severe with repeated use and recovers with rest. Weakness can be localized to specific muscles, such as those responsible for eye movements, but often progresses to affect a broader range, including head, limb, and respiratory muscles. This progression is often described as the generalized, or severe, form of the disease. gMG is estimated to affect approximately 60,000 people in the U.S. alone. gMG symptoms may become life-threatening when muscle weakness involves the diaphragm and intercostal muscles in the chest wall that are responsible for breathing. The most severe complication of gMG, known as myasthenic crisis, requires hospitalization, intubation, and mechanical ventilation.

We may acquire or in-license additional product candidates and technologies. Any product candidate or technologies we in-license or acquire will likely require additional development efforts prior to commercial sale, including extensive pre-clinical or clinical testing, or both, and approval by the FDA and applicable foreign regulatory authorities, if any. All product candidates are prone to risks of failure inherent in pharmaceutical product development, including the possibility that the product candidate, or product developed based on in-licensed technology, will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot assure that any product candidate that we develop based on acquired or in-licensed technology that is granted regulatory approval will be manufactured or produced economically, successfully commercialized or widely accepted or competitive in the marketplace. Moreover, integrating any newly acquired or in-licensed product candidates could be expensive and time-consuming. If we cannot effectively manage these aspects of our business strategy, our business may not succeed.

Boswellia serrata’s gum resin is one such plant used in Indian Ayurvedic and folk medicine to treat blood disorders and curtail inflammatory diseases like rheumatoid arthritis and to promote cardiac health24,25. Present study aims to investigate the mechanism of β-BA, an active triterpenoid compound from the extract of boswellia serrate, to protect endothelial function from blood stasis. Here, β-BA’s effective protection of endothelial function against blood stasis insult is firstly explained.

Rashid, S. et al. Decreased plasma cholesterol and hypersensitivity to statins in mice lacking Pcsk9. Proceedings of the National Academy of Sciences of the United States of America 102, 5374–5379, doi: 10.1073/pnas.0501652102 (2005).

ABBOTT LABORATORIES (NYSE: ABT ) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

In the pre-authorization phase, the applicant must provide a detailed pharmacovigilance plan that it intends to implement post- authorization. An authorization to market a medicinal product in the EU carries with it an obligation to comply with many post- authorization organizational and behavioral regulations relating to the marketing and other activities of authorization holders. These include requirements relating to post-authorization efficacy studies, post-authorization safety studies, adverse event reporting and other pharmacovigilance requirements, advertising, packaging and labeling, patient package leaflets, distribution and wholesale dealing. The regulations frequently operate within a criminal law framework and failure to comply with the requirements may not only affect the authorization, but also can lead to financial and other sanctions levied on the company in question and responsible officers. EU pharmacovigilance legislation has been significantly modified by the Pharmacovigilance Directive, Dir. 2010/84/EU which amended the legal framework of pharmacovigilance for medicines marketed within the EU provided in Regulation (EC) No 726/2004 with respect to EU authorized medicinal products and in Directive 2001/83/EC with respect to nationally authorized medicinal products (including those authorized through the mutual recognition and decentralized systems). In addition, Commission Implementing Regulation (EU) No 520/2012 outlines the practical details to be respected by marketing authorization holders, national competent authorities and the EMA, and Commission Delegated Regulation (EU) No 357/2014 on post-authorization efficacy studies specifies the situations in which such studies may be required. Furthermore, EU good pharmacovigilance practice (GPC) rules apply. With the amended pharmacovigilance requirements, the financial and organizational burden on market authorization holders increased significantly, such as the obligation to maintain a pharmacovigilance system master file that applies to all holders of marketing authorizations granted in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004. Marketing authorization holders must furthermore collect data on adverse events associated with use of the authorized product outside the scope of the authorization. Pharmacovigilance for biological products and medicines with a new active substance is strengthened by subjecting their authorization to additional monitoring activities.

        There are currently two approved disease-modifying therapies for PNH: eculizumab, marketed under the name Soliris®, and ravulizumab-cwvz, marketed under the name Ultomiris™. Both therapies are marketed by Alexion Pharmaceuticals. Eculizumab is approved in the U.S., the E.U., Japan, and additional countries for the treatment of patients with PNH. Ravulizumab-cwvz recently received approval in the U.S., and applications have been accepted and are under review in the E.U. and Japan for approval for the treatment of patients with PNH.

Liao, F. Herbs of activating blood circulation to remove blood stasis. Clin Hemorheol Microcirc. 23, 127–131 (2000).

Possibly the DOOFUS are ruling the world but I don’t have a good answer to that. I can only quote Churchill: “Democracy is the worst form of government, except for all the others”

Speaking of idiot doctors…It would be enormously helpful if people here who have doctors who are knowledgeable – or at least open – to recent aging research would consider sharing their names. My own doctor, thought not an idiot, has severe limitations (she told me that fasting more than 16 hours was dangerous and refused to look at an article about Longo). Doctors who proclaim to be anti-aging often have cheesy websites. It’s hard to find a good doctor without a trustworthy referral. Thank you, Josh, for your extraordinary site and everyone here who contributes. I’m a determined to stay healthy 65, and this site has given me enormous optimism about aging pro-actively. I am not a scientist, so a lot goes over my head, but the discussions fascinates me. Besides being beneficial for my heath, Josh’s site has made a new world of biological research accessible to me. I so appreciate having a ringside seat!

        While some of the changes made by the TCJA may adversely affect us in one or more reporting periods and prospectively, other changes may be beneficial on a going forward basis. We continue to work with our tax advisors and auditors to determine the full impact that the TCJA will have on us on an ongoing basis. We urge our investors to consult with their legal and tax advisors with respect to the TJCA.