Meet us at DIA Europe 2018

 

17-19 April 2018 – BASEL, SWITZERLAND

Opera CRO, a TIGERMED company, will be present at DIA Europe 2018. Meet us @ Tigermed Exhibition Booth No. 105

“DIA is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow.”

Follow DIA Europe 2018 official webpage for meeting programme and other details.

Download the Exhibition Floorplan here (or click on the image below)

 

Timisoara breaks all the preconceptions you can have about Romania

“Timisoara looks like the business card of Romania.

A city that breaks all the preconceptions one can have about Romania. In Timisoara, the houses are renovated, the streets are paved, there is full employment.

In the meantime, there are so many jobs here that the companies could grow much faster, there would not be any shortages of labor now. in Timisoara, wages are now around 500 euros on average, but they are rising rapidly.

The tax is in Romania at a flat rate of 16 percent, people are well-trained, can speak foreign languages. In Timisoara the entrepreneurs say they have never had to pay a cent as bribe to an official.”

Find out more interesting facts about Timisoara reading the full german article on Stern’s official website

How Romania became a popular tech destination

“At first glance Romania seems an unlikely base for cutting-edge tech start-ups. Even regular visitors associate it with misty mountains, medieval churches and potholed roads.

But many reasons seemed to confirm that Romania’s science-savvy workforce, a sizeable and growing domestic market, and EU membership make it a promising European destination for tech investors.”

Find out more on this interesting article posted by FINANCIAL TIMES

 

New Adjuvant Treatment for Breast Cancer approved by FDA

HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. This type of breast cancer is more aggresive than other types of breast cancer.

The drug neratinib (Nerlynx, Puma Biotechnology) was approved by the US Food and Drug Administration as an adjuvant of the treatment of HER2-positive breast cancer.

According to a pivotal phase 3 randomized clinical trial performed on 2840 patients with early stage HER2-positive breast, the 1 year  administration of neratinib led to a disease-free survival rate of 94.2%, comparable with 91,9% at patients treated with placebo. Patients received the study drug and placebo after the treatment with trastuzumab.

The pharmacological action of neratinib is determined by the inhibition of tyrosine kinase and it works by blocking several enzyme that promote the grown of the cancer cells.

More information can be found here.

Proton-pumps inhibitors (PPIs) may be linked to an increased risk of death

Proton-pump inhibitors (PPIs) are widely use for controlling stomach acid and they are available for sale without prescription in many countries.

According to a new clinical study performed by Yan Xie, PhD, from the Clinical Epidemiology Center, Research and Education Service, Veterans Affairs Saint Louis Health Care System in Missouri, and colleagues, use of PPIs can lead to increased risk of death. They analyzed data for more than 6 million people for nearly 6 years — until 2013 or death. Three comparison groups were analyzed: first group, PPIs vs histamine-2 (H2)–blockers, second group  PPI users vs non-users and third group, patients receiving neither PPIs nor H2-blockers.

 

The results have shown that use of PPIs is associated with  increased risk of death compared with use of H2 blockers or no known exposure to any acid suppression therapy.

For more information, please access the full text article.

 

Development of new antibiotics

Antibiotics resistance represents one of the biggest problems of global health. Many infections, such as tuberculosis, pneumonia and gonorrhoea are harder to treat because the antibiotics used for their treatment become less effective.

In order to reduce the antibiotic resistance, European Medicines Agency (EMA), Food and Drug Administration (FDA) and Japanese Pharmaceutical and Medical Devices Agency (PMDA) encourage the clinical development of new antimicrobial agents. During the meeting in Vienna, the representatives from the three regulatory agencies have discussed about the design of new clinical trials for testing new treatments for several bacterial infections.

For more information please access European Medicines Agency website.

The effects of chocolate in cognitive function improvement

Nowadays, decline of cognitive function represents a major health issue and new studies are focused on the detection of preventive agents for cognitive decline and dementia.

Interest in nutraceuticals and functional food has increased in last years. Cocoa represents a rich source of flavonoids, a class of nutraceuticals with polyphenolic structure and several effects on human health, like cardioprotection, neuroprotection, and neuromodulation. Flavonols have antioxidant properties, meaning that they have the ability to reduce the effects of cell damage caused by oxidative stress.

According to a new review published in the journal Frontiers in Nutrition, by Valentina Socci and her colleagues from University of L’Aquila in Italy cognitive function could be improved within few hours after cocoa flavonols consumption. Furthermore, it was found that regular, long-term intake of cocoa flavonols protects againts cognitive decline.

For more information please access the full review article here.

The magic formulas of MD Ana Aslan to prevent aging

Gerovital H3, a romanian brand was marketed after the succes of clinical studies on olderly population.

In 1951, MD Ana Aslan had formulated a procaine product she called Gerovital H3 (GH3) after first studying it as a local anestethic in the National Institute of Gerontology and Geriatrics in Romania.  She initiated a clinical study on a group of 25 patients that received procaine 2%. She was the first gerontologist to study the effects of procaine as an anti-aging tool.

Procaine is an ester composed of PABA (para-amino benzoic acid) and DEAE (diethyl amino ethanol). Both of these are water soluble B vitamins. PABA stimulates the production of folic acid and vitamins K and B1. It has its greatest beneficial effects in the hair, glands and intestines. DEAE is a precursor to choline and acetylcholine. These factors are well known for their importance in nerve function.

Another product containing procaine, Aslavital was formulated later,  in 1970. Aslavital contains additional antioxidants as well as the GH3 ingredients. It is considered to be more potent than GH3 and to be used in addition to GH3 for chronic situations. It is acceptable to take a combination of GH3 and Aslavital.

The beneficial effects of Gerovital have been scientifically recognized. However, some studies have failed to replicate the anti-aging effects. In 1957 GH3 was approved by the romanian Ministry of Health, followind clinical investigations involving 7600 patients but is currently banned in the U.S. by the FDA as an “unapproved new drug”.

Please read the full material here: www.longevity-formulas.com

 

 

Administration of Aspirin in Preeclampsia

Administration of Aspirin in Preeclampsia

 

Decreased incidence of preterm preeclampsia was asscociated with admistration of low doses of aspirin.

Preeclampsia represents one of the most frequent causes of maternal and perinatal morbidity and mortality and the interventions to reduce the prevalence of this desease represent a major challenge in modern obstetrics.

The efficacy of low-dose aspirin administration during pregnancy in prevention of preeclampsia was shown by the researchers from King’s College Hospital, London, England after a double blind clinical trial.

The clinical trial was performed on 1620 pregnant women with high risk of preterm preeclampsia who received a dose 150 mg aspirin per day or placebo from 11 to 14 weeks of pregnancy until 36 weeks of pregnancy. Preterm preeclampsia appeared at 1.6% of participants treated with aspirin, as compared with participants treated with placebo (4.3 %).

For more information, please access the full text article.

 

New Medical Device Regulations!

Challenges for Medical Device manufacturers as the European Medical Device Regulations (MDR 2017/745) will enter into force

Substantial changes were included in the new “REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MEDICAL DEVICES, AMENDING DIRECTIVE 2001/83/EC, REGULATION (EC) No 178/2002 AND REGULATION (EC) No 1223/2009 AND REPEALING COUNCIL DIRECTIVES 90/385/EEC AND 93/42/EEC” published in May 2017 (MDR 2017/745)

The Regulations will enter into force in 26 May 2020 bringing key changes related to the aspects of market surveillance, device identification and traceability, Conformity Assessment, Clinical Evaluation, and Safety.

Medical device manufacturers will be challenged to prove the clinical safety or performance for their medical devices placed on market in a more rigorous way. Requirements for clinical data and clinical investigation will be replacing the equivalence.

Mandatory Unique Device Identification (UDI) will be introduced with the intention to facilitate the traceability of devices.

Also, manufacturers will be required to report a serious incident (or Field Safety Corrective Action (FSCA)) to the relevant using EUDAMED within 15 days, in case of death or unanticipated serious health deterioration the maximum is 10 days. In case of a serious public health threat this timeframe is limited to two days.