Well, any synthetic organic chemist will look at the situation and decide that (1) there’s a process chemistry issue, (2) it seems to apply to common chemical features of the “sartan” angiotensin II antagonists, and (3) it could well be related to some change in the synthetic conditions, because this all didn’t seem to be a problem before. And these are indeed the case, but the details don’t make anyone look particularly good. The common feature, in this case, is the synthesis of the tetrazole ring common to all the sartans. And the change apparently was a solvent switch to dimethylformamide (or presumably diethylformamide, in the cases where NDEA is the contaminant?) The dialkylformamides are often contaminated by small amounts of the corresponding dialkylamines, and they are well known to break down to give those (slowly) under heating.

Semenza, G. L. Oxygen-regulated transcription factors and their role in pulmonary disease. Respir. Res. 1, 159–162 (2000).

Also: ‘Rejuvenating senescent and centenarian human cells by reprogramming through the pluripotent state’ showed that adding NANOG and LIN28 allowed the rescue of senescent cells.

        The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products. While we believe that our technologies, knowledge, experience, and scientific resources provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical, and biotechnology companies, academic institutions and governmental agencies, and public and private research institutions. Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

Korea, New Zealand, Russia, South Africa, and Taiwan. These patents are generally expected to expire between 2018 and 2022, subject to possible patent term extensions. We paid an aggregate amount of approximately $1.4 million and approximately 123,456 shares of common stock in connection with the Cosmix acquisition that includes this fully paid-up license, though no breakdown of amounts specifically attributable to this license is available.

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack, and heart failure. 

I see 3 scenarios for phase 2 ( I am assuming it can measure efficacy to some degree, even if not statistically powered for that): – poor results or high toxicity: end of story – mixed results (no clear improvement but trend toward improvement): could be hard to find funding for phase 3 so the situation is unclear. – good results: this is a revolutionary finding Company is bought or funded by major actor. Phase 3 start ASAP (or maybe FDA could even approve therapy based on phase 2). Other trials for other aging diseases are started. Anti-aging as a whole is acknowledged as a valid approach.

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As a result of the dose response pattern observed in the ARREST Study, we recently conducted a Phase I, open-label, two-period, randomized, crossover PK study to assess whether dose splitting of Aramchol 600mg to twice daily 300mg will significantly increase plasma levels. 16 healthy subjects took part in two study periods. Eight subjects received each regimen in the first period and the alternate regimen in the second period. A PK profile was obtained over the dosing interval at steady state on day ten of each period.

Depending upon the timing, duration and specifics of FDA approval of the use of Aramchol or any future product candidates, U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND, and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for the extension and the application for extension must be made prior to expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply for restorations of patent term for some of our currently owned patents to add patent life beyond their current expiration date, depending on the expected length of clinical trials and other factors involved in the submission of the relevant NDA.

Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.