February 22nd 2024
Research and development funding increased in 2023 but clinical trial starts fell by 15%, partly because of fewer COVID-19-related trials, according to IQVIA's worldwide report on research and development in the biopharmaceutical industry.
Orphan drug program continues to yield treatments for serious conditions
July 3rd 2008The US orphan drug program has demonstrated that economic incentives and regulatory flexibility can spur development of treatments for small patient populations. Since enactment of the Orphan Drug Act (ODA) in 1983, FDA has approved >300 medicines for approximately 12 million patients around the world. However, there are approximately 6,000 to 8,000 rare diseases, so “we still have a very long way to go,” commented Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), at a May conference commemorating ODA’s 25th anniversary, which was sponsored by the Drug Information Association (DIA).
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Tolvaptan is an oral selective vasopressin V2 receptor antagonist that works to produce aquaresis (water diuresis without electrolyte excretion) by blocking the effects of AVP. This effect makes tolvaptan a viable treatment option for patients with acute decompensated heart failure (ADHF) and hyponatremia.
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Reformers seek more comparative effectiveness information to control healthcare spending
June 5th 2008Healthcare reform is a high-profile issue in the presidential election campaign, and drug access has become a central theme in the debate. Both Democratic and Republican candidates have rolled out healthcare reform plans that promise to cover the uninsured while also providing tax breaks and other incentives to help individuals obtain health insurance.
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Electronic medication management system available to improve medication adherence
June 1st 2008In June 2007, FDA approved an Electronic Medication Management Assistant (EMMA) device and electronic medication administration record (eMAR) to help combat problems involving drug identification and dosing.
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Glatiramer, interferon beta-1b comparable in early RRMS
June 1st 2008An investigational 500-mcg dose of interferon beta-1b demonstrated no advantage compared with the approved 250-mcg dose of interferon beta-1b or with glatiramer 20 mg in reducing relapse risk in patients with early relapsing-remitting multiple sclerosis (RRMS), said Paul O'Connor, MD, MS Program Director, St. Michael's Hospital, the University of Toronto, at the 60th Annual Meeting of the American Academy of Neurology, Chicago.
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Glatiramer effective in delaying clinical MS
June 1st 2008Glatiramer represents a new option for delaying conversion of clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (CDMS), according to the results of a new study known as PRECISE, presented at the 60th Annual Meeting of the American Academy of Neurology, Chicago.
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Iloperidone: A novel atypical antipsychotic for the treatment of schizophrenia
June 1st 2008Iloperidone, a new-generation atypical antipsychotic, is currently under investigation for the treatment of schizophrenia. In 4 separate phase 3 trials, iloperidone has demonstrated efficacy in treating schizophrenia, with total Positive and Negative Symptom Scale (PANSS) scores decreasing by a range of 8 to 14 points depending on the iloperidone dose.
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New biologic: Certolizumab pegol (Cimzia), a tumor necrosis factor blocker, was approved on April 22, 2008, for the reduction of the signs and symptoms of Crohn's disease and the maintenance of clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
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Istradefylline: An adenosine receptor antagonist for the treatment of Parkinson disease
May 1st 2008Istradefylline, a highly selective adenosine A2A receptor antagonist, is a new agent being investigated for the adjunctive treatment of the motor signs and symptoms of idiopathic Parkinson disease.
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Approximately 1.7 million healthcare-associated infections (HAIs) occur in US hospitals each year. These HAIs, which include pneumonia, bloodstream infections (BSIs), and urinary tract infections (UTIs), account for approximately 99,000 deaths and $5 billion in additional healthcare costs.
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CDER gains Woodcock as permanent chief
May 1st 2008Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.
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Research disclosure and drug safety monitoring requirements raise new challenges
April 3rd 2008The Food and Drug Administration Amendments Act (FDAAA) enacted in September 2007 requires new initiatives to expand information on the risks and benefits of prescription drugs. One goal established in FDAAA is the modernization of FDA’s system for detecting adverse drug events (ADEs); therefore, the current system is being reviewed so limitations and capabilities can be identified.
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