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Next Generation Pills

Few people like injections, which can limit adherence to therapy and even cause some patients to avoid potentially beneficial treatments altogether. As a result, drug developers have commonly viewed oral delivery as the “gold standard” for many therapies, especially for common chronic conditions. Formulating protein therapeutics for efficient delivery in a pill or capsule, however,...

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FDA Fosters Innovation in Diabetes Care Through New Device Classification

Digital technologies are becoming an increasingly important part of modern healthcare. Medical devices  have the ability to connect to and communicate with other devices or systems. Not only are new types of devices being created, but many existing devices are being updated with digital capabilities. As a result, the U.S. Food and Drug Administration (FDA)...

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Bifunctional Antibodies: The Next Generation of Immuno-oncology Agents

Immuno-oncology agents, particularly checkpoint inhibitors, have moved to the forefront of cancer research and treatment in recent years. Indeed, the discovery that cancer could be treated by activating the immune system was honored with a Nobel Prize in 2018. But, as revolutionary as immuno-oncology drugs have been for the cancer field, many patients still do...

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Alzheimer’s Disease Update

Scientific evidence increasingly points to brain inflammation as a major driver of Alzheimer’s disease (AD). Researchers have discovered that amyloid, one of the hallmarks of the disease, is antimicrobial and may help the immune system fight invaders to the brain. They theorize that accumulating amyloid plaques and tau tangles in response to infection set the...

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The Changing World of Medical Marketing

A recent survey published in the Journal of the American Medical Association (JAMA) reported that the medical marketing spend in the United States rose from approximately $17.7 billion in 1997 to just under $30 billion in 2016. The biggest growth came from Direct-to-Consumer (DTC) marketing, which increased from 11.9% to 32% of the total spend....

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One-and-Done Pricing Challenges

As more gene and cell therapies come to market, a big challenge facing both drug developers and payers is designing and instituting appropriate pricing models for these one-time, potentially curative treatments. Innovation should be rewarded, and a curative — or at least, very long-lasting — treatment is likely to save significant dollars in the typical...

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Drug Pricing: A Key Political Issue for 2019?

Drug pricing is clearly going to be one of the major topics of discussion — and a key political issue — in 2019. Drug makers began the New Year with price increases in the United States on more than 250 prescription drugs. In response, House Democrats, led by the Chairman of the House Oversight Committee,...

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Dsuvia — Much Needed Analgesic or Potential New Contributor to the Opioid Crisis?

Does the United States really need another opioid drug, given the enormous public health crisis of opioid addiction facing the country today? Many experts are asking this question about the FDA’s approval in November of Dsuvia (sufentinil), a powerful opioid  ten times stronger than fentanyl, the drug responsible for many opioid overdose deaths in recent...

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Big Oncology Mergers Kick Off 2019

Each January, a large portion of the international healthcare industry descends on San Francisco for the JP Morgan Healthcare Conference and a variety of other concurrent industry events. The sentiment of the nearly 10,000 attendees — largely influenced by partnering news and big merger/acquisition deals announced around these events — typically sets the tone for...

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Multiple Myeloma: The View from ASH 2018

Multiple myeloma (MM) is a deadly bone marrow cancer. In recent years, the treatment landscape for this disease has improved considerably. However, most patients still relapse and the need for new and better therapeutic options endures.   Encouraging news about several approaches were reported at the American Society of Hematology (ASH) in December. Results from...