FDA looks to industry for help in DSCSA compliance

Although pharma manufacturers and contract packagers are ramping up their capital-equipment purchases to meet the November 2017 deadline for having item-level serialization, many aspects of the Drug Supply Chain Security Act (DSCSA) remain unresolved. Some of these are operational issues […]

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Clinical cold chain vendors go into a deep freeze

Most commercial pharmaceuticals, if they are to be shipped under temperature-controlled conditions, require refrigeration—2–8°C. But the evolving fields of regenerative medicine, in which live cells are being transported, reproductive services, animal husbandry, and, in some research, human tissues and cells, […]

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Oncology: a new era in therapies; same cost concerns

The cliché of building an airplane while in flight might hold with today’s oncology market: new therapies are just on the horizon, while a host of issues around affordability, prescribing practices and reimbursement policies are shifting. Millions of patients are […]

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Managing supply chains from the cloud

For many years, the problems inherent in managing biopharma supply chains have been attacked by IT tools. Today’s systems do a good job of gathering and storing data; producing reports; and executing purchasing, production and disposition orders. “Plan, Source, Make […]

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Changing the payment paradigm

Oncology stands out in the debate over how drugs are priced and paid for in the US, although oncolytics are certainly not the only drugs getting this attention. Nevertheless, the cancer care community—oncologists and health administrators—have issued reports and recommendations […]

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Specialty pharmacy dynamics

As the specialty pharmaceutical marketplace grows, so does the specialty pharmacy provider (SPP) market. And with the former growing at double-digit rates, while traditional retail pharmacy is growing in low single digits, the attraction is obvious. “In 2015, the FDA […]

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