The FDCA also provides for a period of three years of exclusivity if the NDA includes reports of one or more new clinical investigations, other than bioavailability or bioequivalence studies, that were conducted by or for the applicant and are essential to the approval of the application. This three-year exclusivity period often protects changes to a previously approved drug product, such as a new dosage form, route of administration, combination or indication. Three-year exclusivity would be available for a drug product that contains a previously approved active moiety, provided the statutory requirement for a new clinical investigation is satisfied. Unlike five-year NCE exclusivity, an award of three-year exclusivity does not block the FDA from accepting ANDAs seeking approval for generic versions of the

Bristol-Myers Squibb Company (NYSE: BMY ) Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

Incidentally this was the paper that convinced me (not the work on progeria mice Josh has posted about previously) that epigenetic reprogramming might actually work in humans.

BioMarin Pharmaceutical Inc. (NasdaqGS: BMRN ) BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio comprises three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan® (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of peripheral arterial disease and sickle cell disease, and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase 1 clinical development for the treatment of PKU.

Brusselmans, K. et al. Heterozygous deficiency of hypoxia-inducible factor-2alpha protects mice against pulmonary hypertension and right ventricular dysfunction during prolonged hypoxia. J. Clin. Invest. 111, 1519–1527 (2003).

A non-Israeli resident who has dividend income derived from or accrued in Israel, from which the full amount of tax was withheld at source, is generally exempt from the duty to file tax returns in Israel in respect of such income; provided that (i) such income was not derived from a business conducted in Israel by the taxpayer and (ii) the taxpayer has no other taxable sources of income in Israel with respect to which a tax return is required to be filed.

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During 2016, the Company issued a total of 78,750 RSUs. Upon vesting, each RSU will settle by the issuance of one ordinary share. The RSUs vest over four years. As of December 31, 2018, a total of 41,462 ordinary shares were issued upon vesting of 45,309 RSUs and a total of 13,869 RSUs were outstanding, while as of December 31, 2017, a total of 30,932 ordinary shares were issued upon vesting of 30,932 RSUs and a total of 32,348 RSUs were outstanding.

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        In addition, zilucoplan is a synthetic product, and we expect that it can be produced at commercial scale at lower cost than biologics and monoclonal antibodies. As a synthetic, non-biologic product, zilucoplan has essentially no risk for contamination by viruses and animal cell products.

Natural processes are all irreversible processes. So the aging couldn’t be reversed it could only be slowed with all the consequences. For example, If the aging could be slowed 10 times then, the humans could live 1000 years but also the activity of the brain will be slowed accordingly so 10 years will be perceived (in average ) as 1 year.

I’m glad that two of the avenues I’m currently investigating have just been mentioned by others – NF2 pathways and increasing subcutaneous fat! I am convinced these are pathways that will sum with both MTOR inhibition and mitophagy and i’m working on solutions to both, although the subcutaneous fat increasing option might have some risk (so I’d be curious how the Sumo wrestlers do it!)