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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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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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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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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. It should also be noted that one of the videos involved an oral statement made by the CEO of a company which was posted to a third-party site.

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Takeda farms out cancer drug alisertib to Puma Biotech

pharmaphorum

Enter Puma Biotech, which is paying a modest $7 million upfront for rights to alisertib (formerly MLN8237) and plans to run clinical trials of the compound in breast and lung cancers. Takeda is also in line for just over $287 million in potential milestone payments, plus royalties on net sales if it reaches the market.

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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.