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STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid. Patent & Trademark Office granted two more patents, but did not do so until 2008. And critics say this helped ring the register at the expense of the American public.

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Extemporaneous Preparation with Unknown Stability

RX Note

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Kyowa Kirin gets approval in Japan for calcimimetics agent Orkedia Tablets 4mg

Pharmaceutical Business Review

A small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation, Orkedia Tablets suppresses parathyroid hormone (PTH) secretion as it acts on the calcium receptors on parathyroid gland cells.

Dosage 52
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First-year students as instructors: who’s teaching whom? 

Pulses

When I discovered an interest in non-sterile compounding during my first year of pharmacy school, I worked with a professor to create and deliver content. I also had the opportunity to educate younger students by creating an activity for a third-year compounding elective. Peer-Led Team Learning: 2008 James Flack Norris Award Address.

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The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

2 The issue arose because sulfanilamide is an extremely bitter tasting drug and to taste-mask the elixir formulation for use in children, the compounding pharmacist used EG as it was a good solvent, sweet-tasting and cheap. 5 Both compounds are limited to ≤0.1 24 June 2008. percent or 1,000 ppm. Thakur DS, Thikkavarapu PR.

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FCA upholds selection patent protecting apixaban and rejects that a second patented invention was obvious to try

Pharma in Brief

Apixaban was part of the genus of compounds disclosed in the earlier Canadian Patent No. An explicit comparison of apixaban to any other compound of the 330 Patent was not required. On appeal, PMS challenged the trial decision on a number of grounds relating to patent invalidity. Validity of 202 Patent upheld. Selection Patent.

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

NMR relaxation methods distinguish between components (phases or compounds) that have different molecular mobilities For monoclonal antibodies, identification methodologies can employ chromatography, spectroscopy, isoelectric focusing, capillary electrophoresis and peptide mapping techniques. 2008; 364(2): 170–5. Chromatography.