Category Archives: Uncategorized

Alloy four times stronger than titanium, obtained by a researcher Romance | mobile


http://m.ziare.com/scoala/aliaj-metalic-de-patru-ori-mai-rezistent-decat-titanul-obtinut-de-o-cercetatoare-romanca-1430575

A metal super-hard was created in the laboratory by a team of American researchers led by Romanian woman Emilia Morosan at Rice University, Houston, by melting together titanium and gold, thus obtaining the toughest alloy known that proves compatible with living tissues.

Materialulul newly created is four times stronger than pure titanium and has medical applications, extending the life of implants, team members say the researchers. Currently, knee and hip implants conventional need to be replaced due to wear after about 10 years.

Prof. Emilia Morosan, Rice University, said his team made ​​the discovery while studying unconventional magnets made ​​of titanium and gold.

New materials must be turned into powders to verify their purity, but the new alloy obtained – beta-Ti3Au – was too strong to be crushed in a mortar covered with diamonds.

The material “showed the highest hardness of all alloys Ti-Au (titanium gold) and their compounds, and compared to many other alloys in engineering, “said Emilia Morosan.

She said the hardness of the alloy, together with its high biocompatibility, making him a “composed of next generation extending substantially lifetime of dental implants and prosthetic joints.”

It may also have applications in the drilling industry in the sports equipment and many other potential areas, added Emilia Morosan.

Titanium is one of the few metals around which human bones are able to grow strongly, this property allows it to be widely used in medicine and dentistry .

Emilia Morosan was born in 1976 in Suceava. He completed his studies at the Faculty of Physics of the University “Alexandru Ioan Cuza” and obtained his PhD in 2005 at the University of Iowa. After working a while at Princeton University, he became an assistant professor of physics, astronomy and chemistry at Rice University.

In 2010, researcher Romanian woman was honored by President Barack Obama at the gala Presidential Early Career Awards for Scientists and Engineers (PECASE).
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#Cisnadioara, Fortified Church


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#Cisnadioara, Fortified Church

The fortified church is one of the oldest architectural monument built in a genuinely Romanesque style in Transylvania (1223).The general aspect of the Church has remained unchanged to the day.

Source:http://fav.me/d5dee2o
Posted by Diana Talos

Locul MISTIC din România unde toate dorințele se împlinesc | Dezvaluitorul – Misterele dezvaluite


http://dezvaluitorul.ro/templul-dorintelor/

Mick Jagger implineste azi 73 de ani


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Mick Jagger implineste azi 73 de ani
Sir Michael Philip “Mick” Jagger s-a nascut pe data de 26 iulie 1943 in oraselul Dartford din Anglia. Provenind dintr-o familie de profesori, Mick s-a indragostit de muzica si a decis sa-si puna in aplicare pasiunea, initial cantand in corul bisericii, ca mai apoi sa devina celebrul cantaret pe care il cunoastem azi.
Desi a fost tentat sa urmeze o cariera in politica, Jagger a ales sa-si investeasca toata energia intr-un proiect pe care l-a numit “Rollin’ Stone”, dupa numele unei piese compuse de Muddy Waters. Anii 60 au reprezentat avantul unei formatii care avea sa devina ambasadoarea genului rock din intreaga lume.
Dupa 55 de albume si compilatii, 37 de piese in top 10 si peste 200 de milioane de albume vandute in intreaga lume, formatia The Rolling Stones, proiectul de suflet al lui Mick Jagger, a fost clasata pe locul 4 in topul 100 Greatest Artists of All Time.

France 24 : Hollande joins religious leaders in calling for unity after church attack


Hollande joins religious leaders in calling for unity after church attack

http://f24.my/2a4bHiP

President François Hollande displayed interfaith solidarity with France’s religious leaders on Wednesday after two Islamist militants killed a priest in a church, igniting fierce political criticism of the government’s security record.

One of the assailants was a known would-be jihadist awaiting trial under supposedly tight surveillance, a revelation that raised pressure over the Socialist government’s response to a wave of attacks claimed by Islamic State since early in 2015.
“We cannot allow ourselves to be dragged into the politics of Daech (Islamic State), which wants to set the children of the same family against each other,” the Archbishop of Paris, Cardinal André Vingt-Trois, told journalists after the meeting at the Elysee presidential palace.
He was flanked by representatives of other Christian denominations as well as Jewish, Muslim and Buddhist leaders.
Hollande and his ministers were already under fire from conservative opponents over the policing of Bastille Day celebrations in the Riviera city of Nice in which 84 people died when a delivery man drove a heavy truck at revellers.
Former president Nicolas Sarkozy, who is expected to enter a conservative primary for next year’s presidential election, stepped up his attack on Hollande’s record since the first major attack against satirical magazine Charlie Hebdo last year.
“All this violence and barbarism has paralysed the French left since January 2015,” Sarkozy told Le Monde newspaper. “It has lost its bearings and is clinging to a mindset that is out of touch with reality.”
Sarkozy has called for the detention or electronic tagging of all suspected Islamist militants, even if they have committed no offence. France’s internal security service has confidential “S files” on some 10,500 people, although not all are suspected jihadists.
Interior Minister Bernard Cazeneuve rejected Sarkozy’s proposal, saying that to jail them would be unconstitutional and in any case could be counterproductive.
“What has enabled France to break up a large number of terrorist networks is keeping these people under ‘S file’ surveillance, which allows intelligence services to work without these individuals being aware,” he said on Europe 1 radio.
The chairman of France’s conference of religious faiths, Protestant community leader Francois Clavairoly, said after the talks with Hollande that it was impossible to protect every place of worship in the country.
“Everyone has to take responsibility, use best practice and keep an eye open,” he said.
Death at the altar
Tuesday’s attackers interrupted a church service, forced the 85-year-old priest to his knees at the altar and slit his throat. As they came out of the church hiding behind three hostages and shouting “Allahu akbar” (“God is Greatest”), they were shot and killed by police.
The knifemen arrived during morning mass in Saint-Etienne-du-Rouvray, a working-class town near Rouen, northwest of Paris, where Father Jacques Hamel had been celebrating mass. One of the hostages was badly wounded during the attack.
Islamic State said on its news agency that its “soldiers” carried out the attack. It has prioritised targeting France, which has been bombing the group’s bases in Iraq and Syria as part of a U.S.-led international coalition.
Police said they arrested a 16-year-old local youth after the incident but Cazeneuve said on Wednesday he did not appear to be linked to the church attack.
One of the attackers, 19-year-old Adel Kermiche, was a local man who was known to intelligence services after his failed bids to reach Syria to wage jihad.
Kermiche first tried to travel to Syria in March 2015 but was arrested in Germany. Upon his return to France he was placed under surveillance and barred from leaving his local area.
Less than two months later, Kermiche slipped away and was intercepted in Turkey making his way towards Syria again.
He was sent back to France and detained until late March this year when he was released on bail pending trial for alleged membership of a terrorist organisation. He had to wear an electronic tag, surrender his passport and was only allowed to leave his parents’ home for a few hours a day.
Kermiche’s tag did not send an alarm because the attack took place during the four hour period when he was allowed out.
According to the justice ministry, there are just 13 terrorism suspects and people convicted of terrorist links wearing such tags. Seven are on pre-trial bail. The other six
have been convicted but wear the electronic bracelet instead of serving a full jail term.
France was already in a state of shock less than two weeks after the Nice truck attack. In November, 130 people died in shooting and suicide bombings in and around Paris.

In March, three Islamist militants linked to the Paris attackers killed 32 people in suicide attacks on Brussels airport and a metro station in the Belgian capital.
Since the Bastille Day killings in Nice, there has been a spate of attacks in Germany too.
(REUTERS)

France 24 : French church attacker stopped twice from reaching Syria


French church attacker stopped twice from reaching Syria

http://f24.my/2a2Uc25

The 19-year-old Normandy native who killed an elderly French priest during a church service on Tuesday was under house arrest for two failed attempts to reach Syria and was wearing an electronic bracelet at the time of the attack, investigators said.

Adel Kermiche, one of two assailants who attacked a church in Saint-Etienne-du-Rouvray in northern France on Tuesday, was wearing an electronic surveillance bracelet at the time of the attack, according to French Prosecutor François Molins.
Kermiche was first arrested in March 2015 by German police when he tried to use his brother’s passport to travel to Syria. He was returned to his family home but ran away again one month later.
Two months after his first attempt, he tried to go to Syria again via Turkey, but was detained and sent back to France via Switzerland.
Kermiche spent the next several months in a French prison before his release earlier this year but remained under house arrest. The teenager was fitted with an electronic surveillance device that allowed him to leave his house on weekdays between 8am and 12.30pm, Molins said.
The attack happened around 9.25am during morning Mass at a church in Saint-Etienne-du-Rouvray, a suburb of Rouen, when two assailants interrupted the service and charged up to the altar, where they slit the throat of Father Jacques Hamel, an 85-year-old Roman Catholic priest.
The two attackers were shot dead by police as they emerged from the church. The second assailant has not been formally identified.
A ‘sermon’ in Arabic, recorded by attackers
The attack, the first on a Western church claimed by the Islamic State (IS) group, shocked France and has been condemned across the world by religious leaders, including Pope Francis.
Witnesses said the assailants recorded the attack from the altar of the church.
“They forced [Father Hamel] to his knees. He wanted to defend himself, and that’s when the tragedy happened,” a Roman Catholic nun, identified as Sister Danielle, told French media. “They recorded themselves. They did a sort of sermon around the altar, in Arabic. It’s a horror.”
Sister Danielle managed to escape and call the police, who upon arrival tried to negotiate with the hostage-takers through a small door.
But police were unable to launch an assault on the church as three hostages – two nuns and one worshipper – were lined up in front of the door, Molins said.
The hostages then exited the church followed by the two attackers, one carrying a handgun. The assailants charged police, shouting “Allahu Akbar” (“God is great”) before officers opened fire.
One parishioner was severely wounded in the attack.
Charlie Hebdo attack ‘acted as a detonator’
Born in 1997 near the northern French city of Rouen, Kermiche was raised on a housing estate in Saint Etienne-du-Rouvray.
His mother, a teacher, told the Swiss French-language daily Tribune de Genève that the Charlie Hebdo attacks of January 2015 “acted as a detonator” on the teen. “He said we could not practice our religion in peace in France,” she said. “He was speaking with words that did not belong to him. He was bewitched, like he was in a cult.”
Shortly after the family confronted the boy over a secret Facebook account he used to contact other radicalised youth, Kermiche made his first attempt to go to Syria to join the IS group. He used his brother’s passport but was apprehended by German police.
For his second attempt he used his cousin’s ID, but was once again detained and sent back to France, where he was charged with conspiracy to commit a crime with a terrorist organisation and held until March 2016.
‘I knew it was him’
His involvement in the attack came as no surprise to the residents of Saint Etienne-du-Rouvray who knew him. “I saw him last Saturday, in the centre of Rouen,” a neighbour, who identified himself only by his first name of Redwan, told reporters Tuesday morning. “He was wearing a kameez (a long tunic). And this morning … I was told that an attack occurred, and I knew it was him, I was sure.”
According to Redwan, the teen talked openly about his attempts to go to Syria. “We tried to bring him to his senses. [But] every time we did, he cited a verse from the Koran – he was inventing things. He was saying that we should go there (to Syria) and fight for our brothers.”
Police on Tuesday raided the home of Kermiche’s parents, who had alerted French authorities about their son’s radicalisation after the Charlie Hebdo attacks.
A minor was taken into custody on Tuesday morning in connection with the attack.
Attack on ‘crusaders’
The two attackers were carrying a “fake explosive device covered in aluminium foil” when they entered the Catholic church, according to Molins.
Shortly after the police arrived, they used their hostages as human shields to block authorities from entering the church, he said.
Tuesday’s attack by the IS group appears to fulfill its longstanding threat against “crusaders” in what the militants paint as a centuries-old battle for power.
The incident comes as France remains under high alert after an attack in Nice that killed 84 people and a string of deadly attacks last year claimed by the IS group.

BBC News: French church attack: Faith leaders call for more security


French church attack: Faith leaders call for more security – http://www.bbc.co.uk/news/world-europe-36901897

From Wikipedia : SS Washingtonian was a cargo ship launched in 1913 by the Maryland Steel Company


SS Washingtonian was a cargo ship launched in 1913 by the Maryland Steel Company as one of eight sister ships for the American-Hawaiian Steamship Company. At the time of her launch, she was the largest cargo ship under American registry. During the United States occupation of Veracruz in April 1914, Washingtonian was chartered by the United States Department of the Navy for service as a non-commissioned refrigerated supply ship for the U.S. fleet stationed off the Mexican coast.

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Today’s Holiday: Cheyenne Frontier Days


Today’s Holiday:
Cheyenne Frontier Days

What began in 1897 as an attempt to keep alive the sports and customs of the Old West has grown into a week-long festival that regularly attracts over 300,000 visitors. Cheyenne, Wyoming, was one of the wealthiest cattle-raising cities in the world in the 1880s, and now it celebrates its colorful history by staging one of the world’s largest outdoor rodeos. The festival also includes parades of covered wagons, stagecoaches and other old-time vehicles; ceremonial Native American dances; the crowning of a “Miss Frontier” queen; and pageants recreating events from Cheyenne’s past.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Today’s Birthday: Ludovico Sforza (1452)


Today’s Birthday:
Ludovico Sforza (1452)

Sforza effectively ruled Milan from 1480, first as regent for his young nephew and later, after his nephew’s suspicious death, as duke. The patron of Leonardo da Vinci, he presided over the final and most productive period of the Milanese Renaissance but was captured and imprisoned while fighting to expel the French from Italy. Before his fall, he was one of the wealthiest and most powerful princes of Italy, spending immense sums to further the arts and sciences. What painting did he commission?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

This Day in History: Centennial Olympic Park Bombing (1996)


This Day in History:
Centennial Olympic Park Bombing (1996)

During the 1996 Summer Olympics in Atlanta, Georgia, a bombing in Centennial Olympic Park killed one person and injured 111 others. Despite the attack, officials and athletes agreed that the games should continue. Security guard Richard Jewell was initially hailed as a hero for discovering the bomb and helping clear the area before it detonated, but he soon fell under suspicion and was vilified by various media outlets before finally being exonerated. Who was actually behind the bombing?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Quote of the Day: Jonathan Swift


Quote of the Day:
Jonathan Swift

He was a bold man that first eat an oyster.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Article of the Day: Homo Floresiensis


Article of the Day:
Homo Floresiensis

Since their discovery on the Indonesian island of Flores in 2003, small, hominid remains—labeled Homo floresiensis—have divided scientists into two camps. While some believe the remains are the bones of a modern human with a disorder that results in a smaller-than-average skull, others see them as evidence of a newly discovered species in the genus Homo that lived among modern humans and survived until as recently as 12,000 years ago. What arguments have been raised by both sides?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Word of the Day: edification


Word of the Day:
edification

Definition: (noun) Intellectual, moral, or spiritual improvement
Synonyms: enlightenment
Usage: He knew very well that he must tell some story this evening for the edification of the company.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

As a Romanian living in “insulin green” business in which it has invested 100 euros. “I never made the demand”


http://m.adevarul.ro/locale/oradea/insulina-verde-leguma-oradean-dat-lovitura-agricultura-niciodata-nu-facut-fata-cererii-kilogramul-vinde-50-lei-1_5794b1a05ab6550cb8277fe4/index.html

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Lucian coat Oradea (34) are among the first Romanian who have chosen to deal with bitter cucumber culture. It all began in 2009 when, back in Denmark, the young engineer has invested 100 euros horticultural seeds brought from Nepal.
Several years ago, Oradea Lucian fur reading an article about bitter cucumber, so that when she decided to start an agricultural business with such a culture.
“I read about a cucumber that decrease blood glucose. As a horticultural engineer I thought it would be a good culture that would help people, and also a profitable crop, ” he confessed Eng. Lucian coat
The first seeds had bought in Nepal, 100 euros. He began to cultivate bitter cucumbers in a greenhouse than in Oradea, then expanded in culture bihorean Roit village, where he was to cultivate “insulin green” even 2.000 square meters.
“We started with some seed in Nepal. I have grown and I started wondering ecological plasticity of this cucumber. Does not have diseases, are free of viruses. Unlike ordinary cucumbers, one, what surprised me very much. Production is not so great. Only a few cucumbers per plant and seed germinates quite difficult. These were the only inconvenience, “Lucian told us. 
Oradea focused more on selling seeds and powder, but sell and bitter cucumbers, both in Oradea markets and popular websites on sales.

Prices are quite high. One kilogram is sold even 50 lei, but there were times when it was sold and more expensive. Production at the national level is quite low, it reached several hundred kilograms. For now, bitter cucumber plant is very little known in Romania.
“Do not meet demand and I never did. Seed sells for a penny apiece, the kilogram of cucumbers from 30 to 50 lei, while powder sells for 50 money gram or 1 leu. I request from all the counties, but also in Hungary, Poland, Italy or England, “said Oradea.
Fur Lucian returned to Romania after two years in Denmark where he attended a school in agriculture. He returned to the country with the thought of making more money, and do not regret a single moment choice.
“I work a lot of passion and I love everything I do,” says the young Oradea.

Momordica exotic fruit or cucumber is bitter about that, recently, researchers speak as a panacea. The fruit of the plant of Asian origin was dubbed “vegetable insulin”, but also has proven anti-tumor effects and support the functioning of important organs such as the liver or the gall. The cucumbers are bitter and vines can grow in two ways, either on trellises that can stretch up to 3-4 meters, it is left to lie on the ground.
“Cucumber bitter consuption of the meal, according to the patient’s glucose level, from half a cucumber to 3 cucumbers. Contraindications in people who have hypoglycemia and pregnant women, “explains Lucian coat.
Regarding planting seeds, it is done at a distance of one meter between plants and two meters between rows. A plant gives about 20 fruit and their size varies between 50-60 grams, but can reach up to 300 grams.
The plant adapts well soil and climate in our country. Planted in April-May, resisting temperatures up to 14 degrees. Baking needs heat up to 32 degrees. It is very drought resistant, requires no irrigation and has no natural pests.

The fruit can be kept fresh in the refrigerator up to two weeks, can mura, or dried and give the coffee grinder to yield a powder that diabetics who consume a pinch before a meal.
Bitter cucumber is the best remedy, combined with physical movement to combat diabetes. Researchers found that momordica is antitumor and remove power tumors. Also a panacea and helps the pancreas, liver and gall. Even healthy people should consume such fruits, preventive, “says Lucian.
We also recommend:
Bihorean a bright idea who wants to conquer Transylvania. Delivers free vegetables they cultivate with their parents’ help

Realitatea EUROPEANĂ A INVSZIEI MUSULMANE : Andrei Ilarionov, noiembrie 2014


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„Țările și națiunile europene nu ar trebui să fie surprinse, dacă, să spunem, la anul, în primăvară, apare o masivă mișcare politică islamistă, o primăvară islamică în Europa, care va destabiliza țările europene și va consuma energia și atenția liderilor europeni, în timp ce Putin va încerca să-și ducă la capăt proiectele sale neo-imperiale.„ — Andrei Ilarionov, noiembrie 2014

Breathing made easy: give it a try#


http://img.ifcdn.com/images/43c0bf31c89138912ab5b35cb07bc04825f133dcbe113b52c3d4aea2b086c059_1.gif

Fluoride Action Network | PRESS RELEASE: Toxic Waters, Broken Laws


http://fluoridealert.org/articles/texas_fluoride_summary/

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Severe Dental Fluorosis – Photograph by Hardy Limeback, DDS

Severe Dental Fluorosis – Photograph by Hardy Limeback, DDS

Investigation Finds Widespread Failure by Texas Regulators to Notify Residents of Toxic Fluoride Levels

LOS ANGELES, CA – Texas water systems with high levels of naturally occurring fluoride failed to warn consumers about the hazards of fluoride-contaminated water for years, in clear violation of the Safe Drinking Water Act. The violations, revealed in a five-month investigation by the Fluoride Action Network (FAN), resulted from systematic failures at the local, state, and federal levels, placing Texas children at risk for disfiguring dental fluorosis and other potential harms.

High levels of fluoride in water cause a disfiguring tooth condition called dental fluorosis, also known as “Texas Teeth” due to the high levels of fluoride that have long plagued the Lone Star state. In its advanced forms, fluorosis produces extensive brown/black staining, pitting and crumbling of the enamel.  Elevated fluoride levels have been linked to other health effects as well, including learning problems, thyroid disease, and bone fragility.

Severe
Severe Dental Fluorosis – Photograph by Hardy Limeback, DDS
To protect against disfiguring fluorosis, the Environmental Protection Agency (EPA) has established a “Secondary Maximum Contaminant Level” (SMCL) for fluoride, which requires water systems with more than 2 mg/L of the contaminant to warn consumers that children under nine should not drink the water. However, FAN’s investigation reveals that Texas water systems with  more than 2 mg/L fluoride have consistently failed to provide the federally-required warning, dating as far back as 2000.

“Every Texas water system with a fluoride SMCL violation for which we were able to obtain annual water quality reports (19 in all) failed to provide the federally required warning,” states attorney and FAN Executive Director, Michael Connett. “The real culprits, however, are not the local water operators, but the state regulators upon whom the local officials rely when drafting the water quality reports.”

Most annual water quality reports in Texas are prepared by state regulatory officials at the Texas Commission on Environmental Quality (TECQ). “There is no excuse, therefore, for TCEQ to have ever allowed fluoride SMCL violations to go unreported, let alone for so many years,” notes Connett.

In fact, TCEQ specifically told at least one local water operator (Jason Biemer from the city of Kyle) that SMCL notifications are no longer required. Based on TCEQ’s advice, Kyle ceased providing notices for fluoride violations.

The city of Kyle’s experience shows that “TCEQ not only ignored, but actively undermined, the notification requirement for fluoride SMCL violations, which is a key safeguard in the Safe Drinking Water Act for protecting against fluoride harms,” states FAN researcher Doug Cragoe.

FAN’s investigation also revealed a surprising degree of misinformation at the federal level about the requirements for fluoride SMCL violations, with one EPA webpage falsely implying that the fluoride SMCL regulation is completely voluntary, and Outreach Specialists at EPA’s Safe Drinking Water Act hotline repeatedly assuring FAN that notifications are not required for SMCL violations.

Fortunately, FAN’s investigation into Texas’s Safe Drinking Water Act violations has already sparked change, with both local and state officials scrambling to correct the glaring and longstanding violations.  In April 2016, the TCEQ posted an “update” to its website to remind local officials of the need to include SMCL notifications for fluoride, and in June, TCEQ followed up by calling water systems with high levels of fluoride to directly inform them of the SMCL requirement.

“While we are happy our investigation has sparked vital and necessary changes, these changes will be too little, too late for the children who have already been harmed by the widespread negligence of Texas officials,” concludes Connett.

For FAN’s full report, see: http://www.fluoridealert.org

Commentary by Erin Brockovich:
You gotta love the Texas Commission on Environmental Quality… they are notorious for picking and choosing the regulations that they enforce.

” If your system exceeded the fluoride secondary constituent level (SCL) of 2.0 mg/L but has not exceeded the maximum contaminant level of 4.0 mg/L, you are required to notify your customers in the CCR per 30 Texas Administrative Code §290.118(g) and §290.122(d)(3)(B). “

Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM) | Business Wire


http://www.businesswire.com/news/home/20160523005679/en/Janssen%E2%80%99s-Single-Agent-DARZALEX%C2%AE-daratumumab-Approved-European-Commission
Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM)
First-in-class CD38-directed active immunotherapy provides new treatment option for MM patients who have exhausted other approved treatment options

May 23, 2016 06:57 AM Eastern Daylight Time
BEERSE, Belgium–(BUSINESS WIRE)–

“However, there is still a lot of work to be done to ensure that daratumumab is available for patients in health systems across Europe.”
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Janssen-Cilag International NV (“Janssen”) today announced that the European Commission (EC) has granted conditional approval to DARZALEX® (daratumumab) for monotherapy of adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Daratumumab was approved under an accelerated assessment, a process reserved for medicinal products expected to be of major public health interest, particularly from the point of view of therapeutic innovation.1

Daratumumab is the first CD38-directed monoclonal antibody (mAb) approved in Europe. It works by binding to CD38, a signalling molecule highly expressed on the surface of multiple myeloma cells regardless of stage of disease.2-4 In doing so, daratumumab triggers the patient’s own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumour cell death via apoptosis (programmed cell death).5-9

“Despite recent advances, multiple myeloma remains a complex, incurable disease, with relapse being inevitable in almost all patients. With each relapse, the disease typically becomes more aggressive and more challenging to treat,” said Professor Jesús San Miguel, Director of Clinical & Translational Medicine, Universidad de Navarra, Spain. “Daratumumab has shown promising efficacy results and a manageable safety profile as a single agent for heavily pre-treated and refractory myeloma patients. Overall survival improved significantly in these patients, whose prognosis is typically very poor, and who therefore have the greatest need for new treatments.”

The approval of daratumumab was based on data from the Phase 2 MMY2002 (SIRIUS) study, published in The Lancet; the Phase 1/2 GEN501 study, published in The New England Journal of Medicine;10,11 and data from three additional supportive studies. Findings from a combined efficacy analysis of the GEN501 and MMY2002 (SIRIUS) trials demonstrated that after a mean follow-up of 14.8 months, the estimated median OS for single-agent daratumumab (16 mg/kg) in these heavily pre-treated patients was 20 months (95 percent CI, 15-not estimable). The overall response rate (ORR) for the combined analysis was 31 percent, and 83 percent of patients achieved stable disease or better.12 Daratumumab demonstrated a tolerable and clinically manageable safety profile as a monotherapy in heavily pre-treated patients. 10,11 The most common adverse events (AEs) in the Phase 2 MMY2002 (SIRIUS) trial, which occurred in more than 20 percent of patients, were fatigue, anaemia, nausea, thrombocytopenia, back pain, neutropenia and cough.10 The most common adverse events (AEs) in the Phase 1/2 GEN501 trial were fatigue, allergic rhinitis, and pyrexia (fever).11

“Today’s decision on daratumumab is fantastic news for patients as it will help to address a major area of unmet need in people with relapsed or refractory myeloma,” said Sarper Diler, MD, PhD, President of Myeloma Patients Europe. “However, there is still a lot of work to be done to ensure that daratumumab is available for patients in health systems across Europe.”

“The approval of daratumumab within an accelerated timeframe is a result of working with patient-focused urgency, delivering against unmet needs with transformational science and through strong collaborations,” said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. “We are delighted that daratumumab has been approved in Europe and will continue to study its potential across the treatment continuum in multiple myeloma and other tumour types.”

The marketing authorisation approval follows a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued on 01 April 2016.13 This approval allows for the marketing of daratumumab in all 28 member states and the three European Economic Area countries of the European Union.

Janssen has exclusive worldwide rights to the development, manufacturing and commercialisation of daratumumab. Janssen licensed daratumumab from Genmab A/S in August 2012.

#ENDS#

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.14 MM is the second most common form of blood cancer, with around 39,000 new cases worldwide in 2012.15 MM most commonly affects people over the age of 65 and is more common in men than in women.16 The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed patients do not reach five-year survival.17 Almost 29 percent of patients with MM will die within one year of diagnosis.18 Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure. While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.14 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.19

About Daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.2-4 Daratumumab induces rapid tumour cell death through apoptosis (programmed cell death)6,7 and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).5,6,8 Daratumumab has also demonstrated immunomodulatory effects that contribute to tumour cell death via a decrease in immune suppressive cells including T-regs, B-regs and myeloid-derived suppressor cells.9 Five Phase 3 clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed. For more information, please see http://www.clinicaltrials.gov.

About MMY2002 (SIRIUS) and GEN501

These studies included heavily pre-treated patients with relapsed and refractory multiple myeloma who had exhausted other approved treatment options and whose disease was progressive at enrolment. Safety data from the MMY2002 (SIRIUS) and GEN501 trials suggested that daratumumab (16 mg/kg) has a tolerable and clinically manageable safety profile as a monotherapy.10,11

The most common adverse events (AEs) in the Phase 2 MMY2002 (SIRIUS) trial, which occurred in more than 20 percent of patients, were fatigue (40 percent), anaemia (33 percent), nausea (29 percent), thrombocytopenia (25 percent), back pain (22 percent), neutropenia (23 percent) and cough (21 percent).10 The most common adverse events (AEs) in part 2 of the Phase 1/2 GEN501 trial were fatigue, allergic rhinitis, and pyrexia (fever).11 The most frequent haematologic AE was neutropenia (abnormally low levels of neutrophils, a type of white blood cell), which occurred in 12 percent of patients (n=5) in the 16 mg/kg cohort.11

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/janssenEMEA.

Janssen in Oncology

Our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on haematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualised use of our therapies; as well as safe and effective identification and treatment of early changes in the tumour microenvironment.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the anticipated benefits and potential of a newly approved product. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including further investigation of the clinical benefits of the product; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

###

References

  1. Johnson & Johnson. Janssen’s daratumumab accepted for accelerated CHMP assessment for treatment of European patients with heavily pre-treated multiple myeloma. Available at: http://www.jnj.com/news/all/Janssens-daratumumab-accepted-for-accelerated-CHMP-assessment-for-treatment-of-European-patients-with-heavily-pre-treated-multiple-myeloma. Last accessed May 2016.
  2. Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm. 2013;2013:564687.

  3. Lin P, Owens R, Tricot G, et al. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8.

  4. Santoconito AM, Consoli U, Bagnato S et al. Flow cytometric detection of aneuploid CD38++ plasmacells and CD19+ B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in multiple myeloma patients. Leuk Res. 2004;28:469-77.

  5. de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011;186:1840-8.

  6. DARZALEX® Prescribing Information November 2015. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf. Last accessed May 2016.

  7. Jansen JH, Bross P, Overdijk MB, et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;120(21):abstract 2974.

  8. Overdijk MB, Verploegen S, Bögels M, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs 2015;7(2):311-21.

  9. Krejcik J, Casneuf T, Nijhof I, et al. Immunomodulatory effects and adaptive immune response to daratumumab in multiple myeloma. Blood 2015:126(23):abstract 3037.

  10. Lonial S, Weiss BM, Usmani SZ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016;387:1551-60.

  11. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med. 2015;373:1207-19.

  12. Usmani S, Ahmadi T, Ng Y, et al. Analyses of real world data on overall survival in multiple myeloma patients with at least 3 prior lines of therapy including a PI and an IMiD, or double refractory to a PI and an IMiD. Blood. 2015:126(23):abstract 4498.

  13. European Medicines Agency. Committee for Medicinal Products for Human Use: Summary of opinion. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004077/WC500203957.pdf. Last accessed May 2016.

  14. American Society of Clinical Oncology. Multiple myeloma: overview. Available at: http://www.cancer.net/cancer-types/multiple-myeloma/overview. Last accessed May 2016.

  15. GLOBOCAN 2012. Multiple myeloma. Available at: http://globocan.iarc.fr/old/burden.asp?selection_pop=62968&Textp=Europe&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=13&type=0&window=1&submit=%C2%A0Execute. Last accessed May 2016.

  16. American Cancer Society. Multiple myeloma: detailed guide. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf. Last accessed May 2016.

  17. De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68.

  18. Costa LJ, Gonsalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia. 2015;29:1616-8.

  19. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

May 2016

PHEM/DAT/0416/0007

Contacts
Janssen
Media Enquiries:
Natalie Buhl
Mobile: +353 (0)85-744-6696
Email: nbuhl@its.jnj.com
or
Investor Relations:
Lesley Fishman
Phone: +1 732-524-3922
Louise Mehrotra
Phone: +1 732-524-649

JANSSEN

Release Versions
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More NewsRSS feed for Janssen
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Banff, Alberta
Please rate this picture from 1 to 10

Home – ClinicalTrials.gov


https://clinicaltrials.gov/

Haiku: Garabetele, by GeorgeB


Haiku:  Garabetele, by GeorgeB
(The Smudge snd other poems page )

Garabetele
Îşi scoate capul, sf
ios
Din carapace…

Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM) | Business Wire


http://www.businesswire.com/news/home/20160523005679/en/Janssen%E2%80%99s-Single-Agent-DARZALEX%C2%AE-daratumumab-Approved-European-Commission

Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM)
First-in-class CD38-directed active immunotherapy provides new treatment option for MM patients who have exhausted other approved treatment options

May 23, 2016 06:57 AM Eastern Daylight Time
BEERSE, Belgium–(BUSINESS WIRE)–

“However, there is still a lot of work to be done to ensure that daratumumab is available for patients in health systems across Europe.”
Tweet this
Janssen-Cilag International NV (“Janssen”) today announced that the European Commission (EC) has granted conditional approval to DARZALEX® (daratumumab) for monotherapy of adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Daratumumab was approved under an accelerated assessment, a process reserved for medicinal products expected to be of major public health interest, particularly from the point of view of therapeutic innovation.1

Daratumumab is the first CD38-directed monoclonal antibody (mAb) approved in Europe. It works by binding to CD38, a signalling molecule highly expressed on the surface of multiple myeloma cells regardless of stage of disease.2-4 In doing so, daratumumab triggers the patient’s own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumour cell death via apoptosis (programmed cell death).5-9

“Despite recent advances, multiple myeloma remains a complex, incurable disease, with relapse being inevitable in almost all patients. With each relapse, the disease typically becomes more aggressive and more challenging to treat,” said Professor Jesús San Miguel, Director of Clinical & Translational Medicine, Universidad de Navarra, Spain. “Daratumumab has shown promising efficacy results and a manageable safety profile as a single agent for heavily pre-treated and refractory myeloma patients. Overall survival improved significantly in these patients, whose prognosis is typically very poor, and who therefore have the greatest need for new treatments.”

The approval of daratumumab was based on data from the Phase 2 MMY2002 (SIRIUS) study, published in The Lancet; the Phase 1/2 GEN501 study, published in The New England Journal of Medicine;10,11 and data from three additional supportive studies. Findings from a combined efficacy analysis of the GEN501 and MMY2002 (SIRIUS) trials demonstrated that after a mean follow-up of 14.8 months, the estimated median OS for single-agent daratumumab (16 mg/kg) in these heavily pre-treated patients was 20 months (95 percent CI, 15-not estimable). The overall response rate (ORR) for the combined analysis was 31 percent, and 83 percent of patients achieved stable disease or better.12 Daratumumab demonstrated a tolerable and clinically manageable safety profile as a monotherapy in heavily pre-treated patients. 10,11 The most common adverse events (AEs) in the Phase 2 MMY2002 (SIRIUS) trial, which occurred in more than 20 percent of patients, were fatigue, anaemia, nausea, thrombocytopenia, back pain, neutropenia and cough.10 The most common adverse events (AEs) in the Phase 1/2 GEN501 trial were fatigue, allergic rhinitis, and pyrexia (fever).11

“Today’s decision on daratumumab is fantastic news for patients as it will help to address a major area of unmet need in people with relapsed or refractory myeloma,” said Sarper Diler, MD, PhD, President of Myeloma Patients Europe. “However, there is still a lot of work to be done to ensure that daratumumab is available for patients in health systems across Europe.”

“The approval of daratumumab within an accelerated timeframe is a result of working with patient-focused urgency, delivering against unmet needs with transformational science and through strong collaborations,” said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. “We are delighted that daratumumab has been approved in Europe and will continue to study its potential across the treatment continuum in multiple myeloma and other tumour types.”

The marketing authorisation approval follows a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued on 01 April 2016.13 This approval allows for the marketing of daratumumab in all 28 member states and the three European Economic Area countries of the European Union.

Janssen has exclusive worldwide rights to the development, manufacturing and commercialisation of daratumumab. Janssen licensed daratumumab from Genmab A/S in August 2012.

#ENDS#

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.14 MM is the second most common form of blood cancer, with around 39,000 new cases worldwide in 2012.15 MM most commonly affects people over the age of 65 and is more common in men than in women.16 The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed patients do not reach five-year survival.17 Almost 29 percent of patients with MM will die within one year of diagnosis.18 Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure. While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.14 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.19

About Daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.2-4 Daratumumab induces rapid tumour cell death through apoptosis (programmed cell death)6,7 and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).5,6,8 Daratumumab has also demonstrated immunomodulatory effects that contribute to tumour cell death via a decrease in immune suppressive cells including T-regs, B-regs and myeloid-derived suppressor cells.9 Five Phase 3 clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed. For more information, please see http://www.clinicaltrials.gov.

About MMY2002 (SIRIUS) and GEN501

These studies included heavily pre-treated patients with relapsed and refractory multiple myeloma who had exhausted other approved treatment options and whose disease was progressive at enrolment. Safety data from the MMY2002 (SIRIUS) and GEN501 trials suggested that daratumumab (16 mg/kg) has a tolerable and clinically manageable safety profile as a monotherapy.10,11

The most common adverse events (AEs) in the Phase 2 MMY2002 (SIRIUS) trial, which occurred in more than 20 percent of patients, were fatigue (40 percent), anaemia (33 percent), nausea (29 percent), thrombocytopenia (25 percent), back pain (22 percent), neutropenia (23 percent) and cough (21 percent).10 The most common adverse events (AEs) in part 2 of the Phase 1/2 GEN501 trial were fatigue, allergic rhinitis, and pyrexia (fever).11 The most frequent haematologic AE was neutropenia (abnormally low levels of neutrophils, a type of white blood cell), which occurred in 12 percent of patients (n=5) in the 16 mg/kg cohort.11

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/janssenEMEA.

Janssen in Oncology

Our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on haematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualised use of our therapies; as well as safe and effective identification and treatment of early changes in the tumour microenvironment.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the anticipated benefits and potential of a newly approved product. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including further investigation of the clinical benefits of the product; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

###

References

  1. Johnson & Johnson. Janssen’s daratumumab accepted for accelerated CHMP assessment for treatment of European patients with heavily pre-treated multiple myeloma. Available at: http://www.jnj.com/news/all/Janssens-daratumumab-accepted-for-accelerated-CHMP-assessment-for-treatment-of-European-patients-with-heavily-pre-treated-multiple-myeloma. Last accessed May 2016.
  2. Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm. 2013;2013:564687.

  3. Lin P, Owens R, Tricot G, et al. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8.

  4. Santoconito AM, Consoli U, Bagnato S et al. Flow cytometric detection of aneuploid CD38++ plasmacells and CD19+ B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in multiple myeloma patients. Leuk Res. 2004;28:469-77.

  5. de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011;186:1840-8.

  6. DARZALEX® Prescribing Information November 2015. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf. Last accessed May 2016.

  7. Jansen JH, Bross P, Overdijk MB, et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;120(21):abstract 2974.

  8. Overdijk MB, Verploegen S, Bögels M, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs 2015;7(2):311-21.

  9. Krejcik J, Casneuf T, Nijhof I, et al. Immunomodulatory effects and adaptive immune response to daratumumab in multiple myeloma. Blood 2015:126(23):abstract 3037.

  10. Lonial S, Weiss BM, Usmani SZ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016;387:1551-60.

  11. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med. 2015;373:1207-19.

  12. Usmani S, Ahmadi T, Ng Y, et al. Analyses of real world data on overall survival in multiple myeloma patients with at least 3 prior lines of therapy including a PI and an IMiD, or double refractory to a PI and an IMiD. Blood. 2015:126(23):abstract 4498.

  13. European Medicines Agency. Committee for Medicinal Products for Human Use: Summary of opinion. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004077/WC500203957.pdf. Last accessed May 2016.

  14. American Society of Clinical Oncology. Multiple myeloma: overview. Available at: http://www.cancer.net/cancer-types/multiple-myeloma/overview. Last accessed May 2016.

  15. GLOBOCAN 2012. Multiple myeloma. Available at: http://globocan.iarc.fr/old/burden.asp?selection_pop=62968&Textp=Europe&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=13&type=0&window=1&submit=%C2%A0Execute. Last accessed May 2016.

  16. American Cancer Society. Multiple myeloma: detailed guide. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf. Last accessed May 2016.

  17. De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68.

  18. Costa LJ, Gonsalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia. 2015;29:1616-8.

  19. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

May 2016

PHEM/DAT/0416/0007

Contacts
Janssen
Media Enquiries:
Natalie Buhl
Mobile: +353 (0)85-744-6696
Email: nbuhl@its.jnj.com
or
Investor Relations:
Lesley Fishman
Phone: +1 732-524-3922
Louise Mehrotra
Phone: +1 732-524-649

JANSSEN

Release Versions
English German French Spanish Italian EON: Enhanced Online News
More NewsRSS feed for Janssen
Log InSign Up
More from Business Wire
BlogAppsUK/IrelandDeutschlandFranceHong KongItalyJapanEON: Enhanced Online NewsTradeshownews.comPYMNTS.com
Contact UsPrivacy StatementTerms of Use©2016 Business WireShare
Toggle Dock

Downtown no.2


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Downtown no.2

Downtown no.2

Image

Downtown no.1


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Părintele Hamel – ultimul său mesaj în foaia parohială


image

Părintele  Hamel – ultimul său mesaj în foaia parohială. Un mesaj simplu, curat, limpede, ce arată adevărata natură a religiei creștine atât de crunt lovită:

„Primăvara a fost cam rece. Iar dacă spiritul nostru a fost un pic în doliu – răbdare, vara se va instaura în cele din urmă! Și cu ea – vacanța.

Vacanța este un moment în care ne desprindem de activitățile noastre obișnuite. Dar nu e vorba de o simplă paranteză în activitatea noastră. Este timpul relaxării, dar, de asemenea, al revenirii la izvoare, al întâlnirilor, al părtășiei, al convivialității.

Timpul întoarcerii la rădăcinile noaste: unii vor dedica câteva zile unei retrageri spirituale ori unui pelerinaj. Alții vor reciti Evanghelia, singuri sau împreună cu alții, ca pe un cuvânt al zilelor noastre. Alții vor putea reveni la izvorul măreței Cărți a Creației admirând peisaje atât de diferite și de magnifice încât ne înalță și ne vorbesc despre Dumnezeu.
Fie ca noi să auzim în aceste momente invitația lui Dumnezeu de a avea grijă de această lume, de a face din ea, acolo unde trăim fiecare, o lume mai caldă, mai umană, mai fraternă.

Un timp al întâlnirii cu rude și prieteni: o ocazie de a ne găsi timp să trăim ceva împreună. Un timp pentru a fi grijuliu cu altii, oricine ar fi ei.

Un timp al părtășiei: să împărtășim prietenia noastră, bucuria noastră. Să dedicăm timpul nostru copiilor, arătându-le că ei contează pentru noi.

Un timp de rugăciune, de asemenea: atenți la ceea ce se întâmplă în lumea noastră în acest moment. Să ne rugăm pentru cei care au cea mai mare nevoie de rugăciunea noastră, pentru pace, pentru o mai bună trăire împreună.

Acesta va fi Anul Milostivirii. Să avem o inimă trează, deschisă către lucrurile frumoase, către fiecare, către aceia și către acelea care se pot simți un pic mai singuri.

Vacanța să ne dea ocazia de a ne împlini de bucurie, de prietenie și de vindecare, de a ne reîncărca cu puterea rădăcinilor noastre.

Vom putea astfel, mai bine echipați, reporni la drum împreună.
Vacanță fericită tuturor!
Părintele Jacques

http://www.lefigaro.fr/actualite-france/2016/07/26/01016-20160726ARTFIG00151-qui-etait-le-pere-jacques-hamel-egorge-dans-son-eglise-pres-de-rouen.php

Silence is like an empty glass: anything could fill it, anytime. George Bost


Silence is like an empty glass: anything could fill it, anytime.

George Bost.

Today’s article: “Petrus Plancius


Vhttps://en.wikipedia.org/wiki/Petrus_Plancius?wprov=sfla1

Watch “F. Schubert Sonata A major # 20 D.959 Valentina Lisitsa” on YouTube


FagarasExpres More than 2,700 troops will take part in an exercise at Cincu – FagarasExpres


http://fagarasexpres.ro/peste-2-700-de-militari-vor-participa-la-un-exercitiu-la-cincu/

NEWSMore than 2,700 troops will take part in a drill in CincuAnnouncement Hall FagarasHall Fagaras organizational voted! Vacancies. Among them – the city manager and the general manager of the Local PoliceUPDATE: Helicopter been dropped, the tourist will be rescued by Rescue teams and gendarmerie mountainCity Council regular meeting: More money for schools, kindergartens and hospitalMore than 2,700 troops will take part in a drill in CincuAnnouncement Hall FagarasHall Fagaras organizational voted! Vacancies. Among them – the city manager and the general manager of the Local PoliceUPDATE: Helicopter been dropped, the tourist will be rescued by Rescue teams and gendarmerie mountain City Council regular meeting: More money for schools, kindergartens and hospital

Prin Breaza de Făgăraş


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Prin Breaza de Făgăraş

Quota: Constantin Brâncuşi.


image

Există un scop în toate lucturile. Pentru a sjunge acolo, trebuie să te desparți de egoism.
Constantin Brâncuşi.

Sulphur Miners by Renato Guttuso 1911 1987 Date: 1949 private collection New York


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Sulphur Miners
by Renato Guttuso   1911 1987
Date: 1949
private collection New York

Analist american: “Vom asista în curând la dezintegrarea Uniunii Europene. Italia și Ungaria sunt pregătite să părăsească UE!”


http://gandeste.org/general/analist-american-vom-asista-in-curand-la-dezintegrarea-uniunii-europene-italia-si-ungaria-sunt-pregatite-sa-paraseasca-ue-2/72376

Analistul american Frederic William Engdahl afirmă că recenta tentativă de stat din Turcia a fost opera Washingtonului, dar și că în curând vom asista la dispariția Uniunii Europene.

eu puzzle
Într-un interviu acordat publicației belgrădene Vecernje Novosti, analistul susține că Uniunea Europeană a fost concepută în anii ’50 ca un proiect prin care SUA să domine Europa. Acesta consideră că Brexitul va duce la o reacție în lanț, europenii fiind sătui să fie conduși de “birocrați necunoscuți, care decid toate aspectele vieții noastre, de la un minut la altul”.
“Sunt convins că vom fi martorii dezintegrării UE ca și creație politică. Va urma eliberarea țărilor din această alianță, care a fost proiectată încă din anii ’50 ca o modalitate a SUA de a ține sub control Europa. Azi, UE a devenit un monstru în care birocrați fără față decid toate aspectele vieții noastre, de la un minut la altul. Conceptul lui Charles de Gaulle era mult mai bun: state naționale care cooperează, negociază pe probleme comune, dar rămân suverane în fiecare aspect. Italia este un candidat ideal pentru a părăsi UE, la fel și Ungaria. În curând poate fi și Franța, dacă Le Pen câștigă mai mulți aderenți. Atunci totul se va succede cu repeziciune. Moneda Euro este un eșec complet, economia Europei este distrusă în beneficiul mai multor bănci internaționale. Va rămâne în sarcina cetățenilor Europei să decidă în ce viitor vor să trăiască”, a spus el.
În ceea ce privește terorismul, americanul crede că valul de atentate este finanțat de cineva și totul se va opri când banii se vor termina.
“Statul Islamic va dura în funcție de banii care le sunt necesari pentru a-i finanța și antrena. Până acum au venit dinspre Qatar, Arabia Saudită și Turcia -, până de curând. Dacă se termină banii, se va termina și fanatismul”, a declarat Engdahl.
Acesta a spus că dominația americană în domeniile cultural, politic și economic este demantelată pe zi ce trece. Engdahl crede că noile piețe care se deschid în Asia vor muta centrul de importanță al lumii spre Est.
Autor: Andrei Nicolae

Angels and lions, Bernini fountain, piazza Navona / Roma


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Angels and lions, Bernini fountain, piazza Navona / Roma

France 24 : Attacks across Europe: ‘Terrorists are not mentally ill’


Attacks across Europe: ‘Terrorists are not mentally ill’

http://f24.my/2a1RcDh

Several of the perpetrators of recent attacks in Europe, from Nice to this weekend’s suicide bombing in Germany, have been reported to suffer from psychiatric problems. Yet for Dr. Samuel Leistedt, mental illness does not explain their actions.

Mohamed Lahouaiej Bouhlel, the man who killed 84 people at the end of Bastille Day celebrations in Nice, used to have “episodes” during which he “destroyed everything” in sight, his father told Tunisian media after the attack.
The young Syrian refugee who blew himself up near Ansbach, Germany on Sunday, injuring 15, was said to have suffered from depressive episodes and had stayed in a psychiatric hospital after a number of failed suicide attempts.
These horrific acts have raised the question of whether there is a relationship between mental illness and terrorism. But for Dr. Samuel Leistedt, a psychiatrist and professor at the Free University of Brussels who specialises in terrorism, the situation is more complex.
FRANCE 24: Is there a link between terrorism and mental illness?
Dr. Samuel Leistedt: It’s fundamental to understand that a terrorist is not mentally ill in the strictest scientific terms. There are no real signs of mental illness among those we have been able to study. Even if we’ve observed highly narcissistic and paranoid personality traits, it’s not enough to qualify as pathological.
That said, we can make a real distinction between actual terrorism and what we refer to in psychiatric jargon as the “pseudocommando”. Although these are two completely different things, they can both manifest as attacks and mass killings, whether carried out using explosives, a knife or weapons of war.
We use the term pseudocommando because unlike the terrorists involved in some of the more recent jihadist attacks, who were often trained in Syria or Iraq to learn how to use weapons, the pseudocommando often acts alone and without much preparation. He’ll obtain weapons, but will not have necessarily done any physical training – he’s not a warrior.
A pseudocommando can present serious personality disorders, with narcissistic and paranoid tendencies. These are people who will often kill themselves before being caught. A typical example of this kind of profile is Nordine Amrani, the Liège killer, who killed five people in an attack in December 2011 [Amrani, who acted alone, was heavily armed. Among the five killed was a baby. He also wounded more than 121 people before ultimately committing suicide]. The Norwegian Anders Behring Berivik, who killed 77 people in July 2011, also falls into this category, because despite adhering to extreme-right ideology, he acted alone. The question was raised at some point whether he should be committed to an institution. But it’s yet another example of a highly narcissistic personality.
FRANCE 24: What can we make so far of Nice attacker Mohamed Lahouaiej Bouhlel’s profile?
Dr. Samuel Leistedt: We can’t yet determine if he belongs to the pseudocommando category, because he was apparently in contact with the Islamic State group, even though he never travelled to Syria or Iraq. What’s more, it seems as though there was extensive preparation beforehand.
The difference between a pseudocommando and a terrorist is that a terrorist functions as part of a network. Pseudocommandos are isolated, if not lonely. Often, there’s a catalyst for their actions – a divorce, the loss of a job… They don’t let anyone in on their project, and obtain weapons on their own. It’s an isolated and immediate act.
FRANCE 24: According to initial reports, Bouhlel appeared to be extremely psychologically unstable…
Dr. Samuel Leistedt: It’s an exception. Generally terrorists don’t have this type of profile. Depression, ill-being are not the rule. Very few display traits of psychiatric disorders. This man was presented in some media as a psychopath. It was a false analysis. For the moment, that’s not what is emerging. Psychopathy has a very precise definition. A psychopath would not have reacted at all like the killer in Nice: a psychopath doesn’t take, doesn’t kill, doesn’t explode.
FRANCE 24: The Syrian refugee who blew himself up on Sunday in Ansbach, Germany had spent time in a psychiatric hospital. Are people who are mentally vulnerable a target for Islamic State group recruiters?
Dr. Samuel Leistedt: In Europe, Daesh [an alternative name for the Islamic Sate group] recruits from a fertile ground of people who are disenfranchised professionally, socially and who also have family issues – a situation that is particularly common among migrants. They are targeted by Daesh, who seek to use these individuals as moving bombs.
FRANCE 24: Are there any warning signs?
Dr. Samuel Leistedt: Warning signs are very complicated. Yes, there are some, but how do you intervene within a legal and democratic framework when someone hasn’t committed a crime? There are dangerous behaviours, but it’s very difficult to intervene beforehand. How can you tell if someone will decide to take action?
I personally work with research groups that study attacks on Belgian and French soil to better understand as well as prevent them. It’s important to understand what kind of killer we’re dealing with, because the way we extract information from an investigation depends on these profiles. It’s also important in how we judge a criminal in court.

France 24 : Religious leaders express ‘horror’ at attack on church in France


Religious leaders express ‘horror’ at attack on church in France

http://f24.my/2a26ckr

Pope Francis led condemnation of an assault on a church in northwestern France on Tuesday, which claimed the life of an 86-year-old priest and left four people injured, one critically. The Islamic State group claimed responsibility for the attack.

Francis expressed his “horror” at the attack a day before he was due to attend World Youth Day, an international gathering of young Catholics, in Krakow, Poland, where security was immediately tightened in response to the assault.
“We are particularly shocked because this horrible violence took place in a Church, in which God’s love is announced, with the barbarous killing of a priest and the involvement of the faithful,” said Father Federico Lombardi, director of the Holy See press office.
The pope’s comments came hours after two armed men stormed a parish church in the town of Saint-Etienne-du-Rouvray – a suburb of Rouen located around 128 kilometres northwest of Paris – taking the priest, Father Jacques Hamel, and four other people hostage.
The two assailants slit the priest’s throat and wounded the four hostages, one critically, before they were shot dead by elite BRI police who had surrounded the building, according to the interior ministry.
Archbishop Dominique Lebrun of Rouen, who was in Krakow for World Youth Day at the time of the attack, issued a statement calling on both followers and non-believers to come together.
“I cry out to God with all men of goodwill. I invite non-believers to join in the cry. (…) The Catholic Church has no other arms besides prayer and brotherhood among men,” he said, adding that he would be returning to his diocese that night.
There was also an outpouring of support and condolences from other religious leaders across France in the aftermath of the attack.
Mohammed Karabila, president of the Regional Council of the Muslim Faith in Haute-Normandie (Conseil régional du culte musulman de Haute-Normandie), deplored the loss of his friend, Father Hamel.
“I don’t understand, all of our prayers go out to his family and the Catholic community,” Karabila said.
The two men met frequently over the past 18 months as part of an interfaith council to discuss religion and community life. “He was someone who gave his life to others. We are stunned here at the mosque,” Karabila said.
The nationwide French Council of the Muslim Faith (Conseil français du culte musulman or CFCM) echoed Karabila’s comments, denouncing the attack as a “terrifying and horrifying act” and expressing its solidarity with “all Catholics of France”.
“[We call on] all leaders of different faiths to meet, exchange and fight against this hateful speech,” the CFCM said.
The Representative Council of Jewish Institutions in France (Conseil représentatif des institutions juives de France) also condemned the “odious murder”, which it said “marks a new phase in the progession of terrorism in France”.
The Islamic State group claimed the assault on Tuesday via its Amaq news agency. The church attack is the latest in a string of deadly incidents across Europe claimed by the jihadist organisation, including a Bastille Day massacre in the southern French city of Nice and two attacks in Germany last week.

BBC News: France church attack: Priest killed by two ‘IS soldiers’


France church attack: Priest killed by two ‘IS soldiers’ – http://www.bbc.co.uk/news/world-europe-36892785

BBC News: Key Islamic State leader Saad Emarati ‘killed in Afghanistan’


Key Islamic State leader Saad Emarati ‘killed in Afghanistan’ – http://www.bbc.co.uk/news/world-asia-36892100

Quotation: Albert Einstein


When forced to summarize the general theory of relativity in one sentence:
“Time and space and gravitation have no separate existence from matter”.
“People before me believed that if all the matter in the universe were removed, only space and time would exist. My theory proves that space and time would disappear along with matter.”
Albert Einstein

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Sunflower


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From the past: Moby Dick


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Today’s Holiday: RAGBRAI


Today’s Holiday:
RAGBRAI

A bicycle ride (not race) across the state of Iowa, RAGBRAI is billed as the oldest, longest, and largest bicycle-touring event in the nation. The sponsor from the start has been the Des Moines Register, and RAGBRAI stands for Register’s Annual Great Bicycle Ride Across Iowa. The field is limited, and participants are chosen through a drawing. The ride began in 1973 and was intended as a one-time event, but interest was such that it continued the next year, and the next, when it got the RAGBRAI name. The route is different each year but always runs from west to east.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Today’s Birthday: Carl Jung (1875)


Today’s Birthday:
Carl Jung (1875)

Jung was a Swiss psychiatrist and the founder of analytical psychology. Early in his career, he worked with psychiatrist Eugen Bleuler, who studied and named “schizophrenia.” Jung wrote a book on the illness, which led to a meeting with Sigmund Freud, and the two formed a close relationship for a number of years. However, Jung’s criticism of Freud’s emphasis on the sexual basis of neuroses ended their collaboration, and a formal break came when Jung published what revolutionary book?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

This Day in History: The Battle of Edgecote Moor (1469)


This Day in History:
The Battle of Edgecote Moor (1469)

The Battle of Edgecote Moor was an important turning point in the series of dynastic civil wars for the English throne known as the Wars of the Roses (1455-1485). The battle pitted the forces of Richard Neville, Earl of Warwick, against those of King Edward IV. Warwick had once been loyal to Edward and had even helped put him on the throne, but Edward began to resent him and suppress his influence. Angered, Warwick allied with Edward’s brother, George, and rose in rebellion. Who won the battle?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Quote of the Day: Jane Austen


Quote of the Day:
Jane Austen

How quick come the reasons for approving what we like!: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Article of the Day: Cargo Cults


Article of the Day:
Cargo Cults

First appearing in the late 19th c. but particularly prevalent after WWII, when many Pacific Islanders witnessed airdrops of supplies, cargo cults are the unorthodox religious movements that appeared in tribal societies after interaction with Westerners. Believing fallen cargo came from divine spirits who would send more upon seeing rituals based on the foreigners’ behavior, the tribes built straw airplanes, radios made of coconuts, and other pseudo-Western items. Do any cargo cults exist today?: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

Word of the Day: befuddled


Word of the Day:
befuddled

Definition: (adjective) Perplexed by many conflicting situations or statements; filled with bewilderment.
Synonyms: bewildered, confounded, baffled, mixed-up, bemused, lost
Usage: The audience was befuddled by the speaker’s contradictory statements.: https://play.google.com/store/apps/details?id=com.tfd.mobile.TfdSearch

All life is sacred


All life is sacred

France 24 : Erdogan extends post-coup crackdown, meets opposition leaders


Erdogan extends post-coup crackdown, meets opposition leaders

http://f24.my/2ac8Vv9

Turkey’s government on Monday continued its crackdown on those suspected of supporting a failed coup last week as President Recep Tayyip Erdogan made overtures to the political opposition.

Turkey ordered the detention of 42 journalists on Monday, broadcaster NTV reported, as part of a sweeping purge that began immediately after the unsuccessful military coup of July 15.
The crackdown has already targeted more than 60,000 people, drawing fire from the European Union.
The arrests or suspensions of soldiers, police, judges and civil servants have raised concerns among rights groups and Western countries, who fear Erdogan is capitalising on the failed coup to consolidate his grip on power.

The well-known commentator and former parliamentarian Nazli Ilicack was among the 42 journalists subject to arrest warrants, NTV reported.
Meanwhile, the state-run Turkish Airlines said it had fired 211 employees, citing suspected links to US-based preacher Fethullah Gulen, whom Erdogan has blamed for the attempted putsch.
Turkish Airlines said their contracts were terminated due to “the non-fulfilment of performance criteria and in line with the necessary actions we are taking against the FETO structure”, an acronym used by Ankara for Gulen’s movement. Gulen has denied any involvement in the attempted coup.
Erdogan nevertheless made overtures to Turkey’s political opposition on Monday, inviting some of their leaders to meet with him in the presidential palace.

He held a three-hour meeting with Kemal Kiliçdaroglu of the secularist Republican People’s Party (CHP). In a rare show of unity, Kiliçdaroglu said it had been a “positive meeting”.
Erdogan also met with Devlet Bahceli of the right-wing Nationalist Movement Party (MHP).
He did not invite the leader of the left-wing pro-Kurdish Peoples’ Democratic Party (HDP), Selahattin Demirtas, who Erdogan has referred to as a “terrorist” in the past.
The Turkish president has declared a nationwide state of emergency, which allows him to sign new laws without prior parliamentary approval and limit rights as he deems necessary.
The government has said these steps are needed to root out supporters of the coup and won’t infringe on the rights of ordinary Turks.
(FRANCE 24 with REUTERS)