The U.S. Food & Drug Administration Approves Endari, A New Treatment for Sickle Cell Disease

Endari has shown to decrease the number of sickle cell crises and hospitalizations in patients with sickle cell disease. SCD is a rare, debilitating and lifelong hereditary blood disorder that affects approximately 100,000 patients in the U.S. and up to 25 million patients worldwide, the majority of which are of African descent.

Emmaus Life Sciences Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Endari™ (L-glutamine oral powder) to reduce the severe complications of sickle cell disease (SCD) in adult and pediatric patients age 5 and older. Endari reduces oxidant damage to red blood cells by improving the redox potential of nicotinamide adenine dinucleotide (NAD), a coenzyme that has been identified as the primary regulator of oxidation.

"The approval of Endari is a significant milestone for the sickle cell patient community who has not had an advancement in treatment for nearly 20 years and which now, for the first time ever, has a treatment option for children," said Yutaka Niihara, MD, MPH, Chairman and Chief Executive Officer of Emmaus Life Sciences. "Endari reinforces our commitment to discovering innovative therapies that help to improve the lives of people with rare diseases. We thank the FDA for its prompt review and look forward to making treatment available to patients as early as this fourth quarter."

SCD is a rare, debilitating and lifelong hereditary blood disorder that affects approximately 100,000 patients in the U.S. and up to 25 million patients worldwide, the majority of which are of African descent as well as Latinos and other minority groups. Approximately one in every 365 African American children is born with SCD and children between the ages of 2 and 7 are 400 times more likely to suffer from stroke.

Caused by a genetic mutation in the beta-chain of hemoglobin that distorts red blood cells into crescent shapes, SCD lowers oxygen levels in the blood and has an extensive impact on morbidity, mortality and quality of life. Patients often suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells block the blood vessels, resulting in excruciating pain. Sickle cell crises can lead to organ damage, stroke, pulmonary complications, and other adverse outcomes, including acute chest syndrome (ACS), which may be potentially fatal and is the leading cause of death among people with SCD.

"A sickle cell crisis is the most common acute complication for patients and the number one cause of emergency room visits," said Wally Smith, MD, Florence Neal Cooper Smith Professor of Sickle Cell Disease, Division of General Internal Medicine, Virginia Commonwealth University. "Endari has clinically shown to reduce sickle cell crises and hospitalizations, representing a significant medical advancement for patients with limited therapeutic options that have many side effects."

FDA approval was supported by efficacy data from a 48-week randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the effects of Endari, prescription grade L-glutamine, as compared to placebo on 230 adults and children with SCD. The results demonstrated that Endari reduced the frequency of sickle cell crises by 25 percent and hospitalizations by 33 percent. Additional findings showed a decrease in cumulative hospital days by 41 percent and lower incidence of ACS by more than 60 percent.

Safety was based on data from 298 patients treated with L-glutamine and 111 patients treated with placebo in the Phase 2 and Phase 3 studies. Endari's safety profile was similar to placebo and well-tolerated in pediatric and adult patients. The most common adverse reactions occurring in greater than 10 percent of patients treated with Endari were constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain (non-cardiac).

About Emmaus Life Sciences

Emmaus Life Sciences is engaged in the discovery, development and commercialization of innovative treatments and therapies for rare diseases. The company's research on sickle cell disease was initiated by Yutaka Niihara, MD, MPH, Chairman and CEO of Emmaus, at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. For more information, please visit http://www.emmauslifesciences.com.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and potential commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Additional risks and uncertainties are described in reports filed by Emmaus Life Sciences, Inc. with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Emmaus is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

SOURCE Emmaus Life Sciences Inc.

Related Links: http://www.emmauslifesciences.com

White Maryland student indicted in black Army officer's murder

A grand jury indicted a white former University of Maryland student for murder on Thursday in the stabbing death of a black U.S. Army officer that is still being investigating as a possible hate crime, authorities said.

Sean Urbanski, 22, of Severna Park, Maryland, who was a member of a racist Facebook group, was indicted for common-law murder over the on-campus death of Lieutenant Richard Collins III in May, said John Erzen, a spokesman for the Prince George's County state's attorney.

"Right now, the investigation into the motive, including whether it was a hate crime, is still ongoing," Erzen said in a telephone interview.

The Federal Bureau of Investigation was helping police analyze Urbanski's digital devices. "We expect that to conclude in the coming weeks," Erzen said. A police investigation showed that Urbanski was part of the Alt-Reich group on Facebook, where members post disparaging material about African-Americans, Jews and others.

Erzen said prosecutors planned to seek life without parole for Urbanski, who remains jailed without bond. His attorney, William Brennan, did not respond to a request for comment.

[SOURCE]

Bernie Sanders endorses Ben Jealous for Governor of Maryland

Former Democratic presidential candidate Sen. Bernie Sanders weighed into Maryland's race for governor Thursday, endorsing Ben Jealous in the 2018 Democratic gubernatorial primary. Watch Sander's endorsement below.

DHS Debunks Trump Claim That Loretta Lynch Let Russian Lawyer Into U.S.

In his attempts to tarnish President Obama, Donald Trump tries to find a way to blame Obama or his administration for all of his problems. He now blames Obama appointee Loretta Lynch for letting the Russian lawyer into the country that his son foolishly spoke to and attempted to collude with in an attempt to get dirt on Hillary Clinton. Of course like most Trump claims this one isn't true either and the Department of Homeland Security has been quick to point that fact out. George L. Cook III African American Reports.

In the days before her June 2016 meeting with Donald Trump, Jr. and other top Trump campaign aides, Russian lawyer Natalia Veselnitskaya was granted a visa by the US State Department to enter the country.

"In Sept. 2015, DHS paroled Natalia Veselnitskaya into the U.S. in concurrence with the U.S. Attorney's Office, Southern District of New York, allowing her to participate in a client’s legal proceedings," the Department of Homeland Security said in a statement to BuzzFeed News Thursday night.

"Ms. Veselnitskaya was subsequently paroled into the U.S. several times between 2015 and 2016, ending in February 2016. In June 2016, she was issued a B1/B2 nonimmigrant visa by the U.S. Department of State," it said.

The statement contradicts remarks made by President Donald Trump earlier Thursday, suggesting that the Russian lawyer had somehow been allowed into the US by former Attorney General Loretta Lynch.

“Somebody said that her visa or her passport to come into the country was approved by Attorney General Lynch,” Trump said at a press conference in Paris. “Now, maybe that's wrong. I just heard that a little while ago, but a little surprised to hear that. So, she was here because of Lynch."

Almost immediately, a spokesperson for Lynch put out a statement insisting that she had no authority over whether or not the Russian lawyer was allowed to enter the country.

"Lynch, as the former head of the Justice Department, does not have any personal knowledge of Ms. Veselnitskaya's travel,” the statement said.

The Department of Homeland Security confirmed to BuzzFeed News that it granted Veselnitskaya special permission to enter the US in 2015, so that she could participate in a civil court case involving her client, the Russian-owned investment company Prevezon Holdings. The parole status was granted at the behest of the Department of Justice, specifically the Manhattan US Attorney's office, which had accused Prevezon of a massive money laundering scheme.

The timeline of Veselnitskaya's parole status appears to line up with statements she made in court during that case, in which she claimed that she had been denied a visa but granted parole so she could represent Prevezon. But in January 2016, after Veselnitskaya filed an affidavit saying that her parole status would soon expire, Justice Department lawyers told the court that her presence in the US, was no longer necessary.

Veselnitskaya's parole subsequently expired in February 2016, according to DHS. When she returned to the US in June, it was under a standard visitor's visa, newly issued by the State Department. It is not clear what prompted the State Department to change course on its decision to grant Veselnitskaya a visa.

But it was on that trip that Veselnitskaya met with key aides for Donald Trump's presidential campaign, on the premise that she would provide damaging information about Hillary Clinton. She remained in the US until at least the following week, when she traveled to Washington, DC, to push members of Congress into repealing the Magnitsky Act.

[SOURCE: BUZZFEED]

NABJ Gives Thumbs Down Awards to FOX News and Ebony Magazine

The National Association of Black Journalists (NABJ) awards The Thumbs Down Award is presented annually to an individual or organization for especially insensitive, racist or stereotypical reporting of African Americans. While Fox News is a no brainer for this award the inclusion of Ebony Magazine is a bit of a surprise, until you read the NABJ's reasons why Ebony won the "award". George L. Cook III African American Reports.

The National Association of Black Journalists (NABJ) issues its 2017 Thumbs Down Award to FOX News and Ebony magazine.

The Thumbs Down Award is presented annually to an individual or organization for especially insensitive, racist or stereotypical reporting, commentary, photography or cartoon about the black community or for engaging in practices at odds with the goals of the National Association of Black Journalists.

"We take this award very seriously," said NABJ President Sarah Glover. "It is our hope that the recipients would re-evaluate their policies and procedures to ensure that they are following the highest journalistic and ethical standards."

FOX News was selected for numerous reasons. In addition to lawsuits accusing the cable news network of "abhorrent, intolerable, unlawful and hostile racial discrimination," there have also been allegations of sexual harassment. Additionally, the lack of diversity in key positions, is a major concern for NABJ.

"It seems FOX has allowed a very unhealthy environment to fester," said NABJ Vice President of Broadcast Dorothy Tucker. "There has to be a level of accountability and it starts at the top. Management has to do better."

Co-recipient Ebony magazine, under its new owners Clear View Group, has made headlines this year because of staff cuts; the relocation of its headquarters from its founding base in Chicago to Los Angeles; and, its very public and sometimes offensive responses to reports of late or non-payment for work already performed by staff or freelance journalists.

"Many of the decisions being made by Ebony's new owners seem counter to the vision of founder John H. Johnson," said NABJ Vice President of Print Marlon A. Walker. "Ebony and its sister publication Jet are near and dear to us. To hear writers whose words bring us much joy aren't being paid for those words is sad, unconscionable, unacceptable.

"Johnson is probably rolling over in his grave."

FOX News must address its work culture and diversity at all levels of employment, including management positions, and the owners of Ebony magazine must resolve its pay issues with freelancers immediately and work to rebuild its image after several alarming missteps.

[SOURCE: NABJ.COM]