Cancer, Biologics, and Vaccines: 30 Years of Breakthroughs

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By: Mark Crawford

IMG_102730 years logo AAPS Human health is an extraordinarily broad field, with multiple, ever-changing, fronts. Pharmaceutical science achievements—breakthroughs in disease therapies, vaccines, biologics, gene therapy, biotechnology, and nanotechnology, for example—have played critical roles over the last 30 years in improving longevity and the quality of life around the world. With these and other successes, the field of pharmaceutical science has expanded to include drug discovery, biotechnology, clinical pharmacology and translational research, formulation design and development, pharmacokinetics, pharmacodynamics, biopharmaceutics, and manufacturing science and engineering. Continue reading

Can’t You Feel My Pain? Drug Free Methods of Pain Management

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By: Robert G. Bell

Robert G. BellA 2012 National Health Interview Survey (NHIS) found that most American adults experience some level of pain, from acute to chronic, and from relatively minor to more severe. The NHIS survey found that an estimated 25.3 million adults (11.2%) had pain every day for the preceding 3 months and nearly 40 million adults (17.6%) experience severe levels of pain. That’s a lot of pain. And we are taking a lot of medication for this pain. Is there a way to effectively alleviate pain through non-pharmaceutical therapies? You bet there is! Continue reading

Expanded Access: Is It Compassionate Use for Patients?

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By: Ruth Stevens, Cynthia Phurrough, and Angela Drew

Ruth StevensCindy PhurroughAngela Drew

 

 

 

 

 

The recently updated Food and Drug Administration’s (FDA’s) Expanded Access program (commonly referred to as Compassionate Use) has been the subject of several recent news articles and two additional FDA guidances regarding charging for investigational drugs and a new streamlined application form. The timing of the release of the guidances was interpreted as a sign that Sarepta’s eteplirsen product for Duchenne’s muscular dystrophy would not be approved. Continue reading

The Future of Pharma in the Year 0 A.B. (After Brexit)

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By: Ben Locwin

Ben LocwinThe Brexit event has made it clear that pharmaceutical regulation, including market approvals and sales, will be changing. With the divorce between Britain and the European Union (EU)—perhaps it’s more accurate to call it a “conscious uncoupling”—the financial markets have been in flux, including Britain’s credit rating being downgraded, and the falling value of the British pound. In turn, pharmaceutical regulation will also change as a result. How the Medicines and Healthcare Products Regulatory Agency (MHRA) fits into the decision-making of worldwide regulatory approvals, how the European Medicines Agency (EMA) is substantiated in Britain after the uncoupling, and what this means for manufacturers and patients are the three top questions for our industry post-Brexit. Continue reading

Can’t You Feel My Pain? A Primer on Pain

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By: Robert G. Bell

Robert G. BellIn a previous post, I discussed pain and the associated national epidemic with the misuse of pain medication. Everyone has pain, whether it be acute or chronic, and it is an individual struggle. The key is management of the pain through various regimens that may include combinations of physical, medical, and pharmaceutical therapies as well as nontraditional therapies. But what is pain and how is it described? Continue reading

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