One would think that dimethyl signal in the NMR would be fairly distinct from the other methyl functionality in Valsartan. The guys who were making this stuff must have knew something was up.

Wang, Y. et al. Development of fluorescence imaging-based assay for screening cardioprotective compounds from medicinal plants. Anal. Chim. Acta 702, 87–94, 10.1016/j.aca.2011.06.020 (2011).

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(c)      Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

We seek advice from our Scientific Advisory Board generally on scientific and medical matters. Our Scientific Advisory Board includes: Professor Vlad Ratziu, from the University Pierre et Marie Curie in Paris, France and coordinator of the EU FP7 FLIP consortium; Professor Scott Friedman from the Icahn School of Medicine at Mount Sinai in New York, United States; Professor Arun Sanyal, from the Virginia Commonwealth University in Richmond, Virginia; Professor Rohit Loomba, from the University of California San Diego School of Medicine in San Diego, California; Professor Jose Mato, from CIC bioGUNE and CIC biomaGUNE, Spain; and Professor Stephen Harrison, Medical Director of Pinnacle Clinical Research.

Metformin and Berberine both interfere with the electron transport chain, which then triggers AMPK. It is difficult to say how much of their resulting benefit is due to increased mitophagy (the stress part) or MTOR inhibition. I suspect it’s both but have never seen this proven.

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        We have never commercialized a product, and even if one of our product candidates is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. Physicians are often reluctant to switch their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market. Further, patients often acclimate to the therapy that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch therapies. Even if we are able to obtain marketing approval of zilucoplan for the treatment of complement mediated diseases, physicians and patients may decide not to switch to zilucoplan. In addition, even if we are able to demonstrate our product candidates’ safety and efficacy to the FDA and other regulators, safety concerns in the medical community may hinder market acceptance.

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        PNH is a rare, chronic, debilitating, acquired blood disorder that is most frequently diagnosed in early adulthood and usually continues throughout the life of the patient. Some of the prominent symptoms of PNH include severe anemia, a condition that results from having too few healthy red blood cells, severe abdominal pain, severe headaches, back pain, excessive weakness, and fatigue. If not treated, PNH results in the death of approximately 35% of affected individuals within five years of diagnosis and 50% of affected individuals within 10 years of diagnosis, primarily due to the formation of life-threatening blood clots inside the blood vessels, or thrombosis. We estimate that there are approximately 16,000 PNH patients worldwide.

Bachem has extended its product offering with custom manufacturing of cytostatic and cytotoxic peptides and complex organic molecules. These substances are used as active ingredients for cancer therapy and have to be manufactured according to the strictest safety requirements for both staff and the environment.

Preventing situations like this from occurring in the future will be complex, Fuglsang notes, given the different players involved—from the pharmacopeias, which set standards for the APIs and excipients, to the regulatory agencies, whose guidelines refer to the pharmacopeias and standards for development, to finished drug manufacturers who buy API and excipients from subcontractors, to subcontractors who make the API, and the national testing labs, which test products to ensure that they meet standards.