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Posts Tagged ‘life sciences’

France issues stricter rules for pharma trials

lab_franceThe French government took measures last week to lower the health risks to clinical trial participants following the final report regarding a phase 1 clinical trial that killed one person and hospitalized five others in January. France’s health minister Marisol Touraine presented a plan on Monday for stricter rules regarding human drug trials. The plan also requested the Rennes-based Biotrial CRO that conducted the trial to submit a “plan of action” within a month to explain how it will avoid a repeat of these or else lose its operating license.

The report, issued by France’s General Inspectorate of Social Affairs (IGAS), also calls on the government to “mobilize the international scientific community” to find out what went wrong and suggests a range of scientific approaches, such as testing whether the drug hits other brain targets than the intended one and a study of the potential toxicity of the compound’s metabolites. Read more…

3D printing’s breakthrough in the life science market

March 24, 2016 Leave a comment

16661915478_b89cf8096e_qA new item is being introduced into the life science market and it’s getting wide recognition for being the first of its kind: 3D printing. There has been much talk regarding the world of 3D printing but it has not been previously connected with the life science industry. The FDA has approved the first 3D printing drug, produced by Aprecia Pharmaceuticals and its being made to treat seizures and epilepsy.

The 3D pill hit the market earlier this year and questions as to whether the same guidelines apply to the production are arising. When a new drug is introduced, there are several markers that the company must follow, what companies are wondering now is if the same rules apply for a drug that is being 3D printed. Will there be similar guidelines for equipment use and quality control? Quality assurance has been one of the biggest questions surrounding 3D printing in terms of products; with the product now being of a medical background the quality control guidelines are going to be strictly followed and monitored to be sure the product comes out the same as it would under a mechanically generated pill. Read more…

One dead after Phase 1 drug trial in France

January 18, 2016 Leave a comment

er_testtubeA phase 1 drug trial is under scrutiny after one person has died and 5 others are in critical condition following ingestion of the drug. The private laboratory in France, Biotrial, has been testing a pain and mood disorder medication for Bial a Portuguese pharmaceutical company. The drug was a FAAH inhibitor and was supposed to act on the body’s pain, enocannabinoid, system. It had been tested on chimpanzees and just moved to the human phase earlier this month.

A multitude of media outlets have been reporting on the incident and additional details are becoming available to the public.  There are now reports of French prosecutors launching a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers.
Read more…

Life science companies face increased risk of cyber exposure

November 3, 2015 Leave a comment

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Cyber hackers frequently target life sciences companies due to the amount of sensitive data that they possess. Vulnerabilities within the industry often include outsourcing information technology services, limited data storage protection, and inadequate IT policies and procedures. A PwC survey was recently conducted and revealed that almost 50 percent of pharmaceutical and life science organizations have experienced a security breach in the past year; and the biggest threats to these two industries are sophisticated viruses such as Advanced Persistent Threats (APTs) and malware exploits. Read more…

Steps to reduce the risk of nutraceuticals

October 23, 2015 Leave a comment

pills3Dietary supplements, such as amino acids, vitamins, minerals, and other complementary nutrition products, send approximately 23,000 people in the U.S. to the emergency room each year. A new study published in the New England Journal of Medicine reports that there is legitimate risk associated with taking these supplements.

At the hospitals analyzed in the study, researchers connected 3,667 emergency room visits to supplements. Based on these numbers, the study infers that 23,005 adverse events occur each year across the U.S and adults ages 20 to 34 made up 28 percent of hospitalizations. Weight-loss products were attributed to most emergency room visits per year by women, while visits for men were contributed to body building products or sexual enhancement products. Read more…

New insurance template for Swiss clinical trials

October 2, 2015 Leave a comment

clinicalTrialsThe Swiss Ethics Committees on research involving humans has recently released a new certificate of insurance/policy template that insurers must follow. As part of this new format, the Committee now requires the insured risk be categorized as category A, B, or C as outlined by Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance; ClinO) of September 20, 2013 (Status as of January 1, 2014). Insurers do not have the descriptions for the classifications, and are prohibited from providing advice regarding categorization of a trial. Sponsors or their CROs must seek advice from the Swiss Ethics Committees on research involving humans to determine the appropriate classification for their trial. Categorization of the trial is required before the certificate of insurance meets the requirements of the Human Research Act (HRA) and the Ordinance on Clinical Trials in Human Research (ClinO) can be issued. Certificates cannot be issued without the categorization of the Insured risk. Read more…

Court approves Vascepa® for off-label use despite pushback from FDA

pill_bottlesOn Friday August 7th, the Southern District Court of New York permitted Amarin Pharma to promote certain off-label uses of its 2012 FDA-approved drug, Vascepa®. The FDA has made it known that promoting uses of drugs that are not on FDA-approved labeling violates the Food, Drug, and Cosmetic Act (FDCA). This means that a manufacturer can promote its drug for its approved intended use, but a true and non-misleading promotion of an off-label use is considered misbranding. Doing so is prohibited conduct, and could result in penalties and criminal prosecution. Read more…