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The European Medicines Agency recommends suspension of Protelos Servier


Pharmacovigilance Committee of the European Medicines Agency (EMA) has recommended suspending the European market for anti-osteoporosis drug Protelos, Friday announced separately EMA and Servier Laboratories that manufacture it. Following a reassessment, the Committee for Risk Assessment for pharmacovigilance (Prac) "now considers that the benefit / risk Protelos is more favorable," according to a statement from Servier.

Protelos, which was previously indicated for the treatment of severe osteoporosis, finally "have shown a modest effect" on this disease characterized by skeletal fragility and decreased bone mass, explained EMA .

Protelos is marketed in France since January 2006.

It is subject to increased surveillance since 2007 2011 and September, the government decided to limit the terms of repayment.

The Prac conducted a "fundamental reassessment" of the drug and took into account the available data on the risks and benefits of Protelos, a statement of the EMA.

This drug causes for those who take the increased risk of "serious heart condition" including heart attack, the risk of blood clots and stroke, says the BMA.

1.000 on patients treated for one year, the excess risk of heart attacks caused by Protelos is estimated at four.

Similarly, the excess risk of thrombosis is estimated at four (ie four cases of patients suffering from such accidents 1.000 treaties).

The Committee also notes "a number of other risks," as serious skin reactions, consciousness disorders, epileptic-type seizures, or inflammation of the liver or decrease in the number of blood cells.

PRAC's recommendation will be forwarded to the opinion of the Human Medicinal Committee (CHMP) which will decide at its next meeting in January 20 23 2014 to.

In the statement, Servier explain that EMA had already restricted in April 2013 "the conditions of use of Protelos pending a full review of its benefits and risks" because "one in cardiovascular risk newly identified ".

Servier indicates that address the health professionals "detailed information specifying the decision of the CHMP and the practical implications for the care of their patients."

Already, the laboratory notifies all health agencies registered with the Protelos of the proceedings, and set up a hotline for health professionals and patients (0 800 003 936).

2011 in October, the French Medicines Agency (AFSSAPS at the time) had sent a warning to healthcare professionals so that they restrict the use of Protelos, due to serious adverse thromboembolic venous (blood clots), and allergic risk.

The French agency had seized the EMA for a reassessment of the benefit / risk ratio for this drug.

In March 2012 the European health authority had recommended against new indications for the use of Protelos but had always felt it had more benefits than risks.

Sanofi and German Fraunhofer working on infectious diseases


French pharmaceutical group Sanofi and German applied research organization Fraunhofer Wednesday announced the creation of a research center specializing in natural products for developing treatments against infectious diseases.

This center of excellence aims to "accelerate research and discovery of new treatments against infectious diseases, the second cause of death worldwide causing millions of deaths in 10 2011" according to a joint statement.

The two partners have jointly planned to identify new biological and chemical molecules for natural treatments against infectious diseases.

Collaboration could be extended to other indications such as diabetes, pain and rare diseases, "areas in which substances derived from natural products have shown that they can play an important therapeutic and preventive role."

"This cooperation with Fraunhofer is unique and will allow our researchers and external researchers to work together as one team in joint projects, shared in order to acquire new knowledge in order to bring new drugs to laboratories patients with infectious diseases, "said Dr. Elias Zerhouni, President of Research and Development, Sanofi, said in the statement.

Hepatitis C about to be overcome by a new drug cocktail


A new cocktail of two drugs proved very effective against hepatitis C, according to the results Wednesday of a clinical trial showing that this chronic liver infection that killed more Americans than AIDS, would be poised to be defeated.

This study, which focuses on the combination of two antiviral drugs taken orally, the Daclatasvir and sofosbuvir respectively pharmaceutical companies Bristol Myers Squibb and Gilead Sciences, resulted in a cure rate of 98% without significant side effects.

"This research opens the way for safe treatment, well tolerated and effective for the vast majority of cases of hepatitis C," comments Dr. Mark Sulkowski, director of viral hepatitis Centre of the Faculty of Medicine Johns Hopkins (Baltimore, Maryland, is), lead author of the study published in the New England Journal of Medicine in January 16, funded by both laboratories.

"The standard drugs against the disease will experience significant improvement by next year, leading to unprecedented advances in the treatment of patients," he promises.

The clinical trial of phase two was conducted on 211 men and women infected with one of the three strains of the virus responsible for this chronic liver infection, which leads to cirrhosis and liver cancer, requiring a transplant of that organ .

This cocktail was effective even in difficult to treat patients for whom conventional therapy triple (telaprevir or boceprevir plus peginterferon and ribavirin), failed.

Among participants infected 126 1 genotype of hepatitis C, the most common strain in the US, and not having received any prior treatment, 98% were cured.

Similarly, 98 41% of infected again after a triple conventional therapy patients had no trace of the virus in their blood three months after the end of the experimental treatment.

The cure rate was similar in 44 other study participants infected with genotypes and the 2 3 the virus, less common in the United States.


simplified treatment

Participants took a daily combination of 60 400 and Daclatasvir milligrams milligrams sofosbuvir, with or without ribavirin, for three to six months.

With a sofosbuvir conducted clinical trial, combined with the antiviral ribavirin, whose results were published in August 2013, showed a cure rate of 70% in patients with hepatitis C with the damaged liver.

In December, the Food and Drug Administration (FDA), the US drug agency approved the marketing of combined sofosbuvir to peginterferon and ribavirin for the treatment of hepatitis C due to 1 genotype and ribavirin combination only to treat hepatitis C genotype resulting from the 2 3.

The Daclatasvir has not yet been approved by the FDA.

If the agency gives the green light to the placing on the market declatasavir and other new molecules effective against hepatitis C, the dreaded weekly injections of peginterferon will be a thing of the past, according to Dr. Sulkowski.

The treatment of hepatitis C will also be greatly simplified, from 18 tablets daily plus a weekly injection, one or two tablets daily, he said.

According to the federal Centers American control and disease prevention (CDC), less than 5 3,2% of the millions of Americans with hepatitis C were cured.

The CDC also estimate that in 50 75% are unaware of being infected, usually by drug injections, blood transfusions contaminated in 70 and 80 years, or by sexual contact.

French NGOs such as Médecins du Monde see a "great hope" in particular sofosbuvir Gilead, but the cost of 55.000 euros (more than 70.000 dollars) for treatment of 12 weeks puts it out of reach of the majority of countries ill in development.

At least 185 million people are infected with hepatitis C in the world.

The anti-acne Diane 35 Bayer is back in pharmacies


The drug against acne Diane 35, diverted long as contraceptive pills and whose marketing was suspended in France, is again available in pharmacies Wednesday, told AFP Bayer Healthcare.

The discount on the market "as of mid-January" Diane 35 and its generic, subject to restriction of information and strengthening the warnings on the risk of blood clots (venous thrombosis), was announced Monday online evening by the drug agency ANSM.

The latter had suspended the marketing 21 May 2013 but was due to the demand of Europe's back on the market, however under "enhanced surveillance" and strengthening precautions to minimize risk.

The restoration actual sale of generics - Minerva Biogaran of laboratories Epevar Mylan and Cyproterone / ethinylestradiol Teva Health - depends on each of these laboratories.

Other laboratories have given up back on the French market generic.

The new manual intended for patients Diane 35 details the cons-indications and stressed that the risk increases with age and in the smoky (like the pill), especially beyond 35 years.

In practice, Diane 35 and generics are now reserved for the treatment of moderate to severe acne after trying other treatments.

The ANSM and specifies that these products can not be prescribed that "after failure" of treatment to be applied to the skin or antibiotic oral therapy in women of childbearing age.

These drugs are also indicated in cases of excessive hair growth called hirsutism.

Due to their contraceptive effect, they should not be prescribed in conjunction with another hormonal contraceptive.

A nasal vaccine against whooping cough successfully tested on humans


A nasal vaccine against whooping cough with a single dose may be sufficient to protect babies less than six months, has been successfully tested on humans, according to a published Wednesday in the journal Plos One online preliminary study.

Highly contagious respiratory disease that results in fits of violent coughing, whooping cough, bacterial, continues to affect tens of millions of people and cause about 300.000 deaths each year worldwide, particularly among too young to be immunized by current vaccines infants.

It is on the rise in recent years in several Western countries like the United States, Australia, the United Kingdom and France.

Genetically modified and specially designed for nasal administration, the experimental vaccine was developed by a team of European researchers in the framework of a European consortium led by researchers from Inserm.

According to Camille Locht, coordinator of Child-Innovac project was successfully tested in 48 adults as part of a test 1 phase has mainly safety measure its people.

Adults were divided into 4 groups, one receiving a placebo, while the three others have received different doses of the vaccine.

After six months of follow up, the results showed that a single nasal enough to rapidly induce an immune response and the vaccine showed no side effects compared to placebo, even at high doses, "said Dr. Locht.

The next step is to "optimize" the dose needed and "stabilize" the vaccine - which for the moment "is that the temperatures of the order of-80 degrees Celsius" - in order to consider a Industrial Development, he added.

Among the benefits of the vaccine, the researcher cites ease of administration and much less than the vaccines available on the market cost.

Existing vaccines require three injections in total, usually performed 2, and 3 4 months for optimal protection from 6 months, while whooping cough is often severe, even fatal in younger babies.

Developed to fight against whooping cough, nasal vaccine might in addition be used to prevent other respiratory infections such as bronchiolitis in infants (mainly due to a virus, RSV), a "positive effect which was not expected not, "said researcher yet.

Established there are two and a half years, the European consortium Child-Innovac brings together experts from seven European countries and has received funding of € 5 million granted by the European Commission.

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