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

STAT

But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work. Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid.

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Mapping the crisis: How data can help fix America’s growing pharmacy deserts

pharmaphorum

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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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.

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Beating the Big C

Pharmaceutical Technology

The world’s biggest pharmaceutical company Pfizer announced in June 2008 that it would be putting its “full scope and scale” behind a push into the cancer market. “Companies used to be universally protected by patents but there is a pathway to approval opening up for biosimilar legislation. .”

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

Large-molecule drugs such as biologics are particularly sensitive to foreign contamination and E&L interaction, making these issues key concerns for pharmaceutical companies. The number of requirements in the revised Annex 1 has been significantly expanded from the original 2008 version and will come into force on 25 August 2023.

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What to Keep in Your Integrative Medicine Cabinet

The Thyroid Pharmacist

I started talking to Carter Black, RPh, my compounding pharmacist, about the symptoms I was experiencing, and he suggested that I have my adrenals tested. Garlic Oil Garlic is another natural compound that provides a host of health benefits. 2008 Jul;93(7):2559-65. Berberine Berberine is an amazing, multi-faceted herb.