The Department of Justice announced today that a federal criminal complaint has been filed in the Eastern District of Virginia charging defendants Abdelkader and Hnia Amal with immigration offenses in connection with allegations that they held a woman in their home as a domestic servant for three years.

Memorial Hospital (Memorial), an Ohio nonprofit corporation that operates an acute care hospital in Fremont, Ohio, has agreed to pay $8.5 million to settle claims that it violated the False Claims Act, the Anti-Kickback Statute and the Stark Statute by engaging in improper financial relationships with referring physicians.

Dmitry Firtash, 48, a Ukrainian businessman, was arrested Wednesday by Austrian authorities in Vienna on a provisional arrest request based on charges filed in the Northern District of Illinois.

Anthony Williams, of Baton Rouge, La., was sentenced to serve 24 months in prison followed by two years of supervised release, the Justice Department, the Internal Revenue Service (IRS) and the Treasury Inspector General for Tax Administration (TIGTA) announced today.

Attorney General Eric Holder issued the following statement today on the status of same-sex marriages performed in the state of Michigan.

As we convene this morning, I know we’re all mindful of yesterday’s mass shooting at Fort Hood. I am being regularly briefed on the situation and have directed that the full resources of the Department of Justice and the FBI be made available to ensure the security of everyone on base. We will work with local officials and the Department of Defense to provide assistance to those who need it and to help conduct a full and thorough federal investigation.

A co-owner of a Middlesex, N.J., industrial pipes, valves and fittings supply company pleaded guilty today to one count of making a false statement.

Despite significant challenges, the past year has been characterized by remarkable progress – from expanding civil rights for all Americans to holding private corporations accountable for wrongdoing. In the financial sector, concerns have been raised recently about a practice called “high-frequency trading.”

In an important step to reduce sentencing disparities for drug offenders in the federal prison system, Attorney General Eric Holder on Monday announced that the Justice Department will soon detail new, more expansive criteria that the Department will use in considering when to recommend clemency applications for the President’s review.

As part of the Justice Department’s new clemency initiative, Deputy Attorney General James M. Cole announced six criteria the department will consider when reviewing and expediting clemency applications from federal inmates.

The Justice Department’s Office on Violence Against Women announced the release of two grant solicitations to launch a new $3 million special initiative for the Bakken Region.

Two alleged members of the Almighty Imperial Gangsters Nation have been indicted for their alleged roles in a 2007 murder in the Southern District of Florida.

The Justice Department reached an agreement today with Master Klean Janitorial, a company based in Denver, resolving claims that the company engaged in a pattern or practice of discriminatory documentary requests based on citizenship status in violation of the Immigration and Nationality Act.

As difficult as times may be – and as wrenching as every loss we mark this evening – we affirm this week that our work must go on. Each of us is called to serve, to protect, and to help forge a society worthy of the passion, the dedication, and the sacrifices made by each of our fallen heroes. To create not merely a monument to their stories, but a living memorial. And to build a country dedicated to preserving and perpetuating their memories by reaching for the better and brighter future that all of our citizens deserve.

In a speech Tuesday, Attorney General Eric Holder called Syria "a cradle of violent extremism" and urged multilateral law enforcement action to confront the security threat posed by radicalized individuals from the United States and Europe traveling there

Three defendants were arrested today on charges of providing material support to al-Shabaab, a designated foreign terrorist organization that is conducting a violent insurgency campaign in Somalia

Ivan Soto-Barraza, who is charged with the first degree murder of United States Border Patrol Agent Brian Terry, was extradited to the United States from Mexico today, announced Attorney General Eric Holder and U.S. Attorney Laura E. Duffy of the Southern District of California

Five alleged members of the violent Almighty Imperial Gangsters Nation gang have been indicted by a federal grand jury in the Southern District of Florida for their roles in multiple murders. A sixth alleged gang member was indicted for unlawfully possessing a firearm

The Department of Justice has forfeited more than $480 million in corruption proceeds hidden in bank accounts around the world by former Nigerian dictator Sani Abacha and his co-conspirators

A California investment manager was found guilty in federal district court in Salt Lake City, Utah for his role in a $33 million investment fraud scheme

Rosario Rafael Burboa-Alvarez was indicted by a federal grand jury in Tucson yesterday, becoming the seventh man charged in connection with the murder of U.S. Border Patrol Agent Brian Terry, announced Attorney General Eric Holder and U.S. Attorney Laura E. Duffy of the Southern District of California

Waldemar Lorenzana Sr., 75, the patriarch of the Lorenzana drug trafficking organization in Guatemala, pleaded guilty today to conspiracy to import over 450 kilograms of cocaine into the United States

A Detroit-area man was indicted today for obstruction of justice in connection with his alleged attempts to conceal evidence relevant to his upcoming trial for an alleged health care fraud scheme with estimated losses exceeding $30 million.

John P. Carlin, Assistant Attorney General for National Security and Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, announced today that U.S. District Judge Marcia Cooke re-sentenced Jose Padilla to serve 21 years in prison for his 2007 conviction for conspiracy to murder, kidnap and maim individuals in a foreign country; conspiracy to provide material support to terrorists; and providing material support to terrorists.

Shannon Conley, age 19, of Arvada, Colorado, pleaded guilty this morning before U.S. District Court Judge Raymond P. Moore to one count of conspiracy to provide material support to a designated foreign terrorist organization, U.S. Attorney John Walsh for the District of Colorado and Special Agent in Charge Thomas Ravenelle of the FBI Denver Division announced. Conley is scheduled to be sentenced by Judge Moore on January 23, 2015. The defendant appeared at the change of plea hearing in custody, and was remanded at its conclusion.

Attorney General Eric Holder, Assistant Attorney General for National Security John Carlin and U.S. Attorney William J. Hochul Jr. for the Western District of New York announced today that a federal grand jury in Rochester has returned a seven-count indictment charging Mufid A. Elfgeeh, 30, of Rochester, with three counts of attempting to provide material support and resources to the Islamic State of Iraq and the Levant (ISIL), aka the Islamic State of Iraq and Syria (ISIS), a designated foreign terrorist organization. In addition, Elfgeeh is also charged with one count of attempted murder of current and former members of the United States military, one count of possessing firearms equipped with silencers in furtherance of a crime of violence, and two counts of receipt and possession of unregistered firearm silencers.

U.S. Attorney Peter Smith for the Middle District of Pennsylvania, Special Agent in Charge John Kelleghan for Philadelphia, U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and Special Agent in Charge Sidney M. Simon of the New York Field Office, Office of Export Enforcement, U.S. Department of Commerce announced that yesterday Harold Rinko, 72, of Hallstead, Pennsylvania, appeared before Senior District Court Judge Edwin M. Kosik in Scranton and pleaded guilty to conspiracy to illegally export laboratory equipment, including items used to detect chemical warfare agents, from the United States to Syria, in violation of federal law

ALEXANDRIA, Va

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

Continue reading »

The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.

Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis.

Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging.

Avadel Pharmaceuticals plc's (AVDL) pivotal phase III trial evaluating FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy has met its three co-primary efficacy endpoints at all three doses.

Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.

Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space.

Organicell Regenerative Medicine Inc. (BPSR.OB) has received FDA clearance to initiate a phase I/II multi-center clinical trial of Organicell Flow in patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection.

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

Let's take a look at the biotech/pharma companies that are slated to report clinical trial results this quarter.

Probi's largest clinical trial ever, focused on probiotic immune health, has recently been completed.

Finance Ministers from APEC member economies issued a joint statement reflecting the outcomes of the APEC Finance Ministers’ Meeting in Santiago, Chile, chaired by Chile’s Minister of Finance Felipe Larrain.

President Sebastián Piñera, Chair of APEC Chile 2019, announced that APEC Leaders’ Week will not be held in Chile this year.

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.

Over the years, attendees of MAGI Clinical Research Conferences have collected a set of practical, actionable suggestions for improving clinical trials. More than eighty such tips appear in the July 2019 edition of Journal of Clinical Research Best Practices*.  In this post, Polaris auditors weigh in on some of their favorite MAGI suggestions. Surprising no one, they also were eager to share some of their own.

Our Favorites Tips from MAGI

So how does a clinical trial tip earn a spot on our exalted Faves List?  First, it must be something we don’t see too often, or not as much as we’d like.(If most organizations already do a useful thing, it doesn’t really qualify as a helpful tip; it’s really just a common practice.) Second, the effort to implement the tip can’t be too onerous. If a practice requires too much interdepartmental coordination, change management, training, money, or resources, it’s not a tip. It’s a full-blown initiative.

So here they are. Each tip from MAGI attendees is in bold font. Our accompanying commentary is in plain text:

• To help ensure quality study conduct, clinical sites should prepare protocol-specific quality checklists for each study. We’ve written about quality checklists from the auditing perspective before. They’re not a panacea, certainly, but that doesn’t mean they can’t be very useful.
  
  
• After study close-out, sponsors and CROs should consider holding conference calls with groups of sites to capture lessons learned. This in turn could be used to improve training, SOPs, SIVs, etc.
  
  
• As a recruitment aid, clinical sites should create pocket-sized, laminated study cards that list the inclusion/exclusion criteria for a study.  Site staff members can keep these cards in their lab coat pockets and quickly refer to them when treating a patient who could be a potential subject.
  
  
• CROs should share risk assessments and mitigation plans with Sponsors. We agree, but would also encourage CROs to keep the sites involved and aware of risks so they can anticipate them and proceed accordingly.
  
  
• Sponsors/CROs should ensure proper qualifications of vendors prior to executing contracts. It’s hard to argue with this logic, but we don’t see it as much as we should. Too often qualification audits come after the paperwork has been signed. Should the audit uncover noncompliance or quality risks at the vendor site, it’s much harder to get the vendor to make necessary changes after the contract is in place.
  
  
• CROs should align 3rd party contracts with the Sponsor/CRO contract and the Clinical Trial Agreement. Yep.

Additional Tips from Polaris QA/Compliance Auditors

The MAGI list of clinical trial tips brought others to mind that we wanted to share. We applied the same criteria to these suggestions as we did to the MAGI contributions: (1) not necessarily rare, but not as common as it could be, and (2) not overly complex or expensive to implement.

• When evaluating outsourcing partners and clinical sites, Sponsors and CROs should make sure to look at personnel turnover rates. Frequent turnovers may suggest underlying problems that could jeopardize study conduct and quality.
  
  
• Sponsors and CROs should make sure their Monitoring Report templates are consistent with the Clinical Monitoring Plan (CMP). For example:
  
  
• The CMP calls for a focus on a particular set of critical variables, but the report template only has a place for recording that 100% SDV was completed. This means that there’s no way to document that the monitor put special emphasis on anything.
• The CMP requires bi-direction review of study data – a confirmation that what is in the CRF can be verified in the source, and all pertinent data in the source can be found in the CRF – but the report template only allows for the former to be documented.
  
  
• Every member of the site team has valuable input. It’s important to include the study PI, CRC, pharmacist, and other key personnel in the discussions. In 2017, we wrote an article about the important, yet often overlooked, input that the pharmacist on site can provide.
  
  
• There are many reasons that trial participants leave a study, many of which can’t be remedied with improved site practices. But sites that demonstrate they value the participation of their study volunteers, and honor the time they’re spending and contribution they’re making, tend to have better retention results. To that end:
  
  
• To help participants schedule their time, sites can prepare calendars that include all study visit dates and indicate the activities and procedures they entail. (This, of course, needs to be approved by the IRB).
• When participants arrive, they shouldn’t have to sit in a waiting room or empty exam room; they should be seen immediately so they don’t feel their time is being wasted.
• Sites can provide beverages and light snacks to their study participants who especially appreciate them immediately after a fasting blood draw (protocol permitting, naturally). It’s a small courtesy, and not difficult to do. Whose day isn’t brightened by a proffered nosh?**

Uh oh. Now we got you all thinking about mini muffins and cheddar popcorn. Go ahead. Grab a treat. We'll talk later.

________________________________________________________________
 * Journal of Clinical Research Best Practices, July 2019

** Proffered Nosh™ would be a really great name for a restaurant. Or a fictional Scotland Yard Inspector -- legendary for his wit, brilliance, wine pairings, and fashion sense.

The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary…

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

Q: Congress must act on FY 21 appropriations. What are the possible ways for Congress to address this? A: Congress must decide if they will do substantive work on the 12 appropriations bills with the goal of passing full-year funding bills before October 1. One alternative would be to fund the beginning of the fiscal year […]

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

by Alice Wilder, WNYC

Presidential lawyer and former New York City Mayor Rudy Giuliani has largely fallen out of the public eye since his starring role in President Donald Trump’s impeachment. But Giuliani hasn’t gone silent.

Instead, he’s in his home, doing a call-in radio show and a podcast — “Common Sense” — during which he has repeatedly gone on bigoted rants about China and its government.

“They have no morals,” he said on his April 28 radio show. “They’re amoral in the sense that human life means something in Western civilization, it means a lot. Human life doesn’t mean the same thing to them.”

Giuliani has also speculated that the spread of the coronavirus may be a plot by the Chinese government.

For example, Giuliani has raised the possibility that China purposely released the virus from a biological lab in Wuhan. “We have to say accidentally,” Giuliani said in a recent radio broadcast. “But I don’t think as responsible investigators we can rule out that it wasn’t done deliberately.”

Experts say there’s no public evidence the virus came from the lab. Amid a reported White House push, U.S. intelligence agencies have said they are investigating the origins of the virus.

Giuliani is also fixated on the idea that the Chinese government sent sick people overseas. In an April 27 episode of his podcast, he said that China allowed “over a million people from Wuhan travel to us, to the United States, to England to France to Italy to Germany.” He added, “I hope the people there have the same reaction we have to the value of human life and the loss of human life.”

“When they found out about this terrible virus that escaped, assuming they didn’t do it on purpose,” Giuliani said a day later on his radio show, “they were going to make sure the West suffered as much if not more than they did and jumped on top of an opportunity, it’s not a big assumption to make. And there isn’t a contrary explanation.”

The New York Times found that thousands, not millions, of people flew internationally out of Wuhan.

Asked about his comments, Giuliani did not respond.

The comments by Giuliani have come as discrimination against Asian Americans has spiked. And they reinforce the White House’s emerging push to blame China for the pandemic.

Giuliani has said he’s spoken to the president a number of times about the coronavirus. Two days after Giuliani said he was sure the virus came from the Wuhan lab, Trump said he has evidence of the same. (The president declined to give the evidence, saying it’s secret.)

Giuliani appears to have found a receptive wider audience too. An advertising executive at 77 WABC, which airs Giuliani’s radio show, said “feedback has been amazing” and online listening has “skyrocketed.”

The station’s parent company, Red Apple Media, did not respond to a request for comment.

In an April 23 radio show, Giuliani interviewed Gordon Chang, a conservative pundit who frequently predicts the collapse of the Chinese government. Chang said if China released the virus accidentally — for which, again, there’s no evidence — it then decided to create a global pandemic. “I think what Xi Jinping did was he decided he was going to spread the virus so that he would level the playing field so that China would not be in such a hole,” Chang said, referring to China’s president.

“Wow,” Giuliani responded. “So he saw an opportunity, if that theory is correct, and it wasn’t a bioweapon to start with, he saw an opportunity that was sort of accidentally presented to him, and then he took advantage of it. It was opportunistic.”

Chang acknowledged, “We can’t know what was in Xi Jinping’s mind for sure.” But then he went on, “It looks more like they were deliberate and malicious and that means Mr. Mayor ... this is a crime against all of humanity.”

Giuliani ended the interview by inviting Chang to be a guest on his other show, the podcast.

Giuliani has also said he’d use his access to help guests on his show move ahead with exploratory treatments. Talking with one pharmaceutical executive on his show in late March, Giuliani told his guest, “I’ll use whatever my yelling and screaming can do to do it faster, to help you.”

As the Times reported, the executive’s company received initial trial approval from the Food and Drug Administration soon after. (The FDA has said the application was subject to “internal scientific review.” And Giuliani has said he has no business connection to the company.)

“I don’t lobby the government,” Giuliani emailed in response to a request for comment. “I do hope, however, that they and others are successful.”

Giuliani appears to have strong feelings about the government’s process for approving drugs.

In an April 23 broadcast, Mark, a pharmacist from New Jersey, called in to report on his “informal study” of the patients who have used a drug cocktail that includes hydroxychloroquine — the anti-malaria drug that Trump long has touted.

Giuliani was excited when Mark reported that none of his patients had been hospitalized: “Why doesn’t this count with all these geniuses in Washington? The double blind study and the triple blind study and this study and that study, we don’t have time for that, we’ve got to go to people like Mark in New Jersey!”

In fact, the FDA has warned against widespread use of the drug, noting that it can cause heart problems.

The discussions with his listeners, though, often come back to China.

One caller to Giuliani’s radio show, identifying himself as “George from Bay Ridge,” went on a rant against Chinese people, likening them to serial killers with “no conscience” who are attempting to take over businesses all over the world.

Giuliani responded, “George, I’ve been getting complaints about this for a long time.” He added: “It almost reminds me of the Mafia. You know, they say, if you do business with America it’s one thing. If you do business with China you don’t realize, all of a sudden you start owing them too much and they believe they own you.”

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by Yeganeh Torbati

Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies.

“Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.”

ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead.

Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.”

In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday.

The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March.

On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures.

Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak.

The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million.

Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely.

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