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Key FDA Actions Anticipated in 2018

Key FDA Actions Anticipated in 2018

The FDA approved a number of new therapies and indications for a variety of conditions this past year (read our 2017 recap here). With 2017 behind us, we’re looking ahead at the next year for what’s on the horizon in pharmacy. These are some of the upcoming drugs slated for review by the FDA in... Read More »

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The FDA approved a number of new therapies and indications for a variety of conditions this past year (read our 2017 recap here). With 2017 behind us, we’re looking ahead at the next year for what’s on the horizon in pharmacy. These are some of the upcoming drugs slated for review by the FDA in… Read More »

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By: Jason Marcewicz  |  Content and Communications Specialist | Advanced Medical Strategies Specialty drugs continue to outpace traditional brand-name pharmaceuticals and generics, both in percentage of growth and absolute costs. In 1990 there were 10 specialty drugs on the market. By the mid-1990s, about 30. In 2015, 300. That year the average annual price of… Read More »

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Advanced Medical Strategies (AMS) is pleased to release our 4th annual Top 5 list of the most commonly researched specialty drugs of 2017.   For the PredictRx Top 5 Researched Drugs of 2017, Remicade again tops the list as the one AMS clients inquired about the most during the past 12 months. Industry professionals should… Read More »

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2017 drug approvals: Records, milestones, and controversies

In his first year as FDA Commissioner, Scott Gottlieb has chaperoned the agency through a blockbuster 2017 with 46 novel drug approvals to date. The final tally is the highest seen this century, surpassing the previous record holder 2015, which clocked in at 45. Both were more than double 2016’s sad tally of 22 new molecular... Read More »

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In his first year as FDA Commissioner, Scott Gottlieb has chaperoned the agency through a blockbuster 2017 with 46 novel drug approvals to date. The final tally is the highest seen this century, surpassing the previous record holder 2015, which clocked in at 45. Both were more than double 2016’s sad tally of 22 new molecular… Read More »

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FDA Approvals in 2017

By: Jason Marcewicz  |  Content and Communications Specialist | Advanced Medical Strategies The FDA approved 46 new molecular entities (NMEs) in 2017, the most in over two decades. (Just 22 NMEs were approved in all of 2016; the average approval rate for the past decade is about 30 per year.) This list of so-called novel... Read More »

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By: Jason Marcewicz  |  Content and Communications Specialist | Advanced Medical Strategies The FDA approved 46 new molecular entities (NMEs) in 2017, the most in over two decades. (Just 22 NMEs were approved in all of 2016; the average approval rate for the past decade is about 30 per year.) This list of so-called novel… Read More »

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FDA permits marketing of device to treat diabetic foot ulcers

December 28th, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The... Read More »

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December 28th, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The… Read More »

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Not Just Mylan: Misclassifications May Have Cost Medicaid More Than $1B

The US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) released a report this week finding that drugmakers may have caused the Medicaid program to lose out on $1.3 billion for 10 potentially misclassified drugs from 2012 to 2016. The release of the report follows a settlement between Mylan and the... Read More »

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The US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) released a report this week finding that drugmakers may have caused the Medicaid program to lose out on $1.3 billion for 10 potentially misclassified drugs from 2012 to 2016. The release of the report follows a settlement between Mylan and the… Read More »

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U.S. Life Expectancy Is Falling Because Fentanyl Drug Overdoses Are Killing Americans in Terrifying Numbers

Late last year, a man went to his 10-year high school reunion in a small town just outside of Charleston, West Virginia. His close-knit community meant no one was forgotten a decade after graduation. “Everyone knows who is there and who is not there,” said Dr. Daniel Ciccarone, a researcher from the University of California, San Francisco. The former classmates began... Read More »

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Late last year, a man went to his 10-year high school reunion in a small town just outside of Charleston, West Virginia. His close-knit community meant no one was forgotten a decade after graduation. “Everyone knows who is there and who is not there,” said Dr. Daniel Ciccarone, a researcher from the University of California, San Francisco. The former classmates began… Read More »

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DaVita Rx hit with $63.7 million DOJ settlement over improper billing and kickback allegations

DaVita Rx, the Coppell, Texas-based pharma giant that serves patients with severe kidney disease, has agreed to pay $63.7 million to resolve allegations relating of improper billing practices and kickbacks to federal healthcare program beneficiaries, the Justice Department announced today. The agreement settles allegations that DaVita Rx billed federal healthcare programs for prescription medications that... Read More »

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DaVita Rx, the Coppell, Texas-based pharma giant that serves patients with severe kidney disease, has agreed to pay $63.7 million to resolve allegations relating of improper billing practices and kickbacks to federal healthcare program beneficiaries, the Justice Department announced today. The agreement settles allegations that DaVita Rx billed federal healthcare programs for prescription medications that… Read More »

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Gene Therapy May Allow Hemophilia Patients to Go Without Meds

Gene therapy has helped 10 men with a form of the bleeding disorder hemophilia produce a critical blood clotting factor. This could eliminate the need for tedious and costly standard treatments, researchers report. While saying the one-time gene therapy was an ideal treatment goal because of its effects, the researchers stopped short of calling it... Read More »

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Gene therapy has helped 10 men with a form of the bleeding disorder hemophilia produce a critical blood clotting factor. This could eliminate the need for tedious and costly standard treatments, researchers report. While saying the one-time gene therapy was an ideal treatment goal because of its effects, the researchers stopped short of calling it… Read More »

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