Tag Archives: FDA

EMA, MHRA and U.S. FDA among regulatory agencies participating at PDA’s 4th Annual European Meeting in Amsterdam

BERLIN, 10-Jun-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.

From the Max Planck Institute for Human Development, Felix G. Rebitschek will deliver the keynote speech, “Decision-Making Under Uncertainty.” Following him, the opening plenary “Regulatory Updates – Current Situation” will discuss understanding regulatory frameworks in an atmosphere of rapid change and provide the opportunity to participate in conversation with regulators and industry representatives.

Regulatory agencies sharing industry updates include the European Medicines Agency, U.S. FDA, WHO, MHRA and HPRA, PIC/S.

A series of parallel tracks will offer the chance to learn about topics ranging from virtual reality, data quality management, manufacturing technologies and much more.

Learn more about the topics that will be examined in-depth.

Registration (https://store.pda.org/Meetings/Login.aspx?ID=4520) can be completed until June 24.

Bona fide members of the press are welcome to apply for a press pass.

SOURCE: EuropaWire

Narconon Trois-Rivieres Looks into the Painful Drug Addictions Caused by OxyContin Abuse

When OxyContin was first manufactured, no one knew what type of destruction this particular drug would cause those who got caught up in abusing or misusing the drug. Perdue Pharma L.P. first introduced the drug in 1995 to help people battling cancer, and soon after the drug was being recommended for treating moderate to severe pain cases. When this happened, sales eventually sky rocketed, and in 2003 there were 1.6 billion dollars of worldwide sales. Perdue Pharma were being severely criticized by the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) for its very aggressive marketing tactics and ability to encourage physicians to prescribe the drug.

In the late 1990’s the Chief Coroner of Ontario at that time was noticing more people were dying from prescription drug overdose. When he asked for forensic scientists to review the drug related death files for the past five years, it was found that there was a major increase in deaths where Oxycodone was found in the blood stream. In 2003, there were 101 deaths in Ontario where the person had Oxycodone in their blood stream. The Chief Coroner at the time reported seeing this increase in deaths around the same time that the drug was being aggressively marketed. Many of the people who died where drug abusers, but many of the people who died from accidental overdose or suicide, were prescribed drugs with Oxycodone in it, and OxyContin being the most popular.

Perdue Pharma defended their drug saying it was no different then any other pain medication being marketed. Unfortunately, there was no other documentation of other pain medications causing the same problems at the time. Atlantic Canada was facing similar problems, and still is to this very day. They have been seeing dangerous social problems that have involved OxyContin abuse. In 2003 pharmacies dispensed over 2.8 million prescriptions for drugs containing Oxycodone in Canada, mainly Ontario, and the most popular was OxyContin. For more information call, 1-877-782-7409, or visit the web site at, http://narconon.ca/

(Ref: Works Cited CTV.ca News Staff “Deadly Prescriptions” CTV.ca 10 Jan. 2005:

Via EPR Network
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Jenken Biosciences Granted Key Patent for Compounds To Treat Chronic Liver and Kidney Diseases

Jenken Biosciences, Inc., an emerging specialty pharmaceutical company, announced today that the United States Patent and Trademark Office (USPTO) has granted a patent on Jenken’s compounds for the treatment of diseases associated with kidney diseases and chronic liver diseases, such as hepatitis and fatty liver disease.

Jenken’s patented compounds are developed by “repurposing” FDA-approved off-patent drugs for new, first-in-class therapeutic uses.

The patent, US 7501433, “Opioid and opioid-like compounds and uses thereof,” with an anticipated term through 2022, will provide broad protection for the Company’s repurposed drugs’ new indications targeted at treating organ damage associated with chronic liver or kidney diseases.

The Company’s leading drug candidate has been approved by the FDA for a Phase II clinical study targeted at treating liver damage in Hepatitis patients. The endpoint of the study will be to restore normal liver function by reducing inflammation in Hepatitis C patients who do not respond to current interferon/anti-viral therapies.

Jenken’s second clinical candidate has exhibited efficacy in preclinical trials as an anti-fibrotic for treating fatty liver disease.

“The validation by the USPTO of the potential utility of our compounds is a significant step in making totally new therapeutic options available to the millions of patients around the world who suffer from chronic liver diseases, such as hepatic fibrosis, steatohepatitis (NASH) or fatty liver disease,” said Barry Buzogany, Jenken’s President and CEO.

“In the U.S. alone, approximately 25 million people are afflicted with some form of chronic liver disorder,” Buzogany explained. “Of these, there are about four million people infected with the Hepatitis C virus and another 12 million with fatty liver disease. Currently there are no therapies available to treat liver damage associated with either hepatitis or with fatty liver disease.”

According to Dr. Edwin Wu, Jenken’s Founder and Chief Scientific Officer, “Jenken’s proprietary technology for cytokine modulation, a specific therapy for diseases associated with chronic inflammation, offers the potential to restore normal liver or kidney function regardless of the cause of the damage or disease.”

Via EPR Network
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