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August 15, 2018

Researchers Generate Immune Cells to Create Cancer Vaccines

Cancer is a leading cause of death worldwide, accounting for 8.8 million deaths in 2015.  Cancer arises from the transformation of normal cells into tumor cells in a multistage process that generally progresses from a pre-cancerous lesion to a malignant tumor.  With so many patients and families affected by cancer, research in this area is a constant source of interest. (more…)
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August 10, 2018

Biosimilars: Growing Pains in a New Arena

One of the key strategies for enhancing access to affordable medicines posed by the Trump administration involved establishing the pathway for the development and approval of high-quality biosimilar therapies.  Yet, out of 11 approved products, only three biosimilars are on the market eight years after the enactment of legislation streamlining the process.  If current trends continue, it may be months or years before Americans gain access to these medications. (more…)
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July 25, 2018

New Research on Spinal Cord Injury

The spinal cord is very sensitive to injury, and unlike other parts of your body, lacks the ability to self repair when damaged, making spinal injuries potentially devastating. A spinal cord injury — damage to any part of the spinal cord or nerves at the end of the spinal canal (cauda equina) — often causes permanent changes in strength, sensation and other body functions below the site of the injury.  An injury can occur when there is damage to the spinal cord from trauma, restriction of blood supply, or compression from a tumor or infection. There are approximately 12,000 new cases of spinal cord injury each year in the United States, most frequently in males. (more…)
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July 18, 2018

Long Acting Treatment for Schizophrenia May Offer New Hope

Schizophrenia, Latin for "split mind," is a chronic, severe and disabling brain disorder, affecting an estimated 2.4 million American adults and their families.  The hallmark of schizophrenia is disorganized thinking, which can manifest as positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal).  Although schizophrenia is not as common as other mental disorders, the symptoms can be very disabling. In the past, there were different classes of schizophrenia, also known as 'subtypes'. Disorganized schizophrenia, catatonic schizophrenia and schizoaffective disorder have since been absorbed into the larger diagnosis of schizophrenia, but are still used to describe the widely varied ways schizophrenia can manifest from person to person.  (more…)
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May 31, 2018

Insomnia: The Hidden Costs of Poor Sleep

Insomnia is a common problem for people of all ages, with a number of people suffering from an inability to sleep.  Based on estimates derived from population-based studies, approximately 30% of adults worldwide report symptoms of insomnia: difficulty initiating or maintaining sleep, waking up too early or poor quality of sleep.  Common comorbidities associated with insomnia are psychiatric disorders, with an estimated 40% of all insomnia patients experiencing a coexisting psychiatric condition.  Among these psychiatric disorders, depression is the most common, and insomnia is a diagnostic symptom for depressive and anxiety disorders. (more…)
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May 16, 2018

Ketamine and Depression

Depression is one of the most life-threatening mental illnesses in the United States today. Treatment resistant depression, which does not respond readily to talk therapy or medication — the most frequently prescribed treatments for major depression — can lead to self loathing, isolation and thoughts of suicide. Suicide is currently among the leading causes of death in America.  Even medication can have drawbacks, with first line therapies often taking as long as 6 to 8 weeks before being effective. Faced with the long timeline of drug therapy and unwanted side effects, patients with severe depression sometimes turn to nontraditional treatments such as electroconvulsive therapy and perhaps surprisingly, ketamine therapy — a drug known as ‘Special K’ by recreational drug users. A staggering 70% of patients responded to ketamine therapy for treatment of depression in one study performed.  The study examined the use of intravenous ketamine  for depressed patients at imminent risk of suicide, and with the rapid response shown by patients, makes ketamine a…
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March 13, 2018

High Potency Compounds-Taking on the Challenge

  As a pharmaceutical or biotech company, if you haven't had to deal with high potency API (HPAPI) compounds yet, chances are you will eventually.  Approximately 25 percent of drugs in development worldwide are classified as highly potent, with this percentage expected to grow over the coming years; the global HPAPI market is expected to reach nearly $26 billion by 2022. HPAPIs are a rapidly growing segment of the pharmaceutical industry, primarily due to an increased focus on targeted therapeutics, especially in oncology.  A compound is classified as highly potent if it has an occupational exposure limit (OEL) of ≤10μg/m3, a daily therapeutic dose of ≤10mg/day or if a 1 mg/kg/day dose produces serious toxicity in laboratory animals. 25% of drugs currently in development worldwide are highly potent. (more…)
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March 5, 2018

The Days of Clean Sheeting for Cost of Goods are Over.

We have all been there when we need to determine various costs and where they come from.  We stare at spreadsheets, trying to gather the necessary data, critical and nonessential, and using our calculations to determine how we can lower costs.  This approach is not only time consuming, but inaccurate and inefficient, but what are the alternatives? (more…)
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September 14, 2017

AI Innovation in Pharma

  Artificial intelligence is more than just a concept for the newest blockbuster movie, it is moving into mainstream science and the pharmaceutical industry as well.  The Korea Pharmaceutical and Bio-pharma Manufacturers Association has recently announced the launch of a team focused on purchasing artificial technology for drug development.  Artificial intelligence computing systems can be used to analyze molecular interactions, and predict drug efficacy and side effects.  The technology can be utilized to guide and optimize clinical trial planning, greatly reducing the timeline for new drug development. (more…)
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