The Justice Department announced today a settlement agreement with the Clay County School District in Alabama

The Justice Department announced today that U.S. District Court Judge Otis D. Wright II of the Central District of California entered a consent decree of permanent injunction against GM Manufacturing Inc. (GMM) and Mao L. Yang, Mary Chen and David Yang on Friday, June 20, 2014, to prevent the distribution of adulterated dietary supplements

The Justice Department announced today that it reached a settlement with the Delran Township School District in New Jersey under Title II of the Americans with Disabilities Act (ADA).

The Department of Justice announced today that it will require Martin Marietta Materials Inc. to divest one Oklahoma quarry and two Texas rail yards in order to proceed with its proposed $2.7 billion acquisition of Texas Industries Inc.

According to court documents submitted today, BNP Paribas S.A. (BNPP), a global financial institution headquartered in Paris, agreed to enter a guilty plea to conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA) by processing billions of dollars of transactions through the U.S. financial system on behalf of Sudanese, Iranian, and Cuban entities subject to U.S. economic sanctions

The Justice Department announced today that the U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction against Triceutical Inc. and its president, Liqun Zhang, of Farmingdale, New York, to prevent the distribution of adulterated dietary supplements

This fourth annual report to Congress describes efforts to collect and improve data on crime and justice in Indian country, as required by the Tribal Law and Order Act of 2010. The report details the number of tribal law enforcement agencies reporting crime data to the FBI’s Uniform Crime Reporting program. It describes BJS’s first National Survey of Tribal Court Systems which will collect data on tribal courts in the lower 48 states and Alaska covering 566 tribes

The Justice Department announced today that the U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction against Applied Polymer Systems dba APS Pharmaco (APS) and its president, Nuka Reddy, all of Lindenhurst, New York, to prevent the distribution of adulterated dietary supplements

The Justice Department today announced the payment of more than $1.5 million in damages under a consent decree previously reached with QuikTrip Corporation. The payments were made by QuikTrip to compensate 47 individuals with disabilities who experienced discrimination at QuikTrip gas stations and convenience stores across the country, in violation of Title III of the Americans with Disabilities Act (ADA).

Attorney General Eric Holder and United States Attorney for the Southern District of New York Preet Bharara announced today the completion of the Justice Department’s multi-year civil investigation pursuant to the Civil Rights of Institutionalized Persons Act (“CRIPA”) into the conditions of confinement of adolescent male inmates on Rikers Island. The investigation, which focused on use of force by staff, inmate-on-inmate violence, and use of punitive segregation during the period 2011-2013, concluded that there is a pattern and practice of conduct at Rikers Island that violates the rights of adolescents protected by the Eighth Amendment and the Due Process Clause of the Fourteenth Amendment of the United States Constitution. The investigation found that adolescent inmates are not adequately protected from physical harm due to the rampant use of unnecessary and excessive force by New York City Department of Correction (“DOC”) staff and violence inflicted by other inmates

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

A civil complaint was filed today in federal court in Michigan against S. Serra Cheese Company of Clinton Township, Michigan, and its owners, Stefano and Fina Serra, to prevent the distribution of adulterated cheese, announced Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division

McKesson Corporation has agreed to pay $18 million to resolve allegations that it improperly set temperature monitors used in shipping vaccines under its contract with the Centers for Disease Control and Prevention (CDC), the Justice Department announced today. McKesson is a pharmaceutical distributor with corporate headquarters in San Francisco

A Russian national indicted for hacking into point of sale systems at retailers throughout the United States and operating websites that distributed credit card data of thousands of credit card holders appeared today for arraignment in U.S. federal court, announced U.S. Attorney Jenny A. Durkan of the Western District of Washington and Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division

The remaining two defendants of 36 accused in the Southern District of Texas of racketeering activities as part of their roles with the Aryan Brotherhood of Texas (ABT) have pleaded guilty, capping a six-year sweeping effort that has led to 73 convictions across five federal districts and the decimation of the gang’s leadership and violent members and associates. Those convicted were charged with involvement in a criminal organization that engaged in murders, kidnappings, brutal beatings, fire bombings and drug trafficking

The Civil Rights Division of the Department of Justice, working closely with the U.S. Attorney’s Office for the Eastern District of Michigan, reached a comprehensive settlement agreement with the Crestwood School District in Dearborn Heights, Michigan, to improve educational services for students who are English Language Learners (ELLs), establish a system for recruiting and hiring faculty and staff and ensure that individuals who complain about discrimination do not face unlawful retaliation

Mr. Chairperson, distinguished members of the committee, and representatives of civil society, it is an honor to be a part of the U.S. delegation and share some of the highlights of the Department of Justice’s efforts to eliminate racial discrimination and uphold human rights in the area of criminal justice.

The former chief executive officer of Hanover Corporation was sentenced today to serve 14 years in prison, to be followed by three years of supervised release and ordered to pay $14,784,983.75 in restitution for orchestrating an $18 million Ponzi scheme

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 Louisiana psychiatrist was sentenced in federal court in Baton Rouge, Louisiana, today to serve 86 months in prison for his role in a $258.5 million Medicare fraud scheme involving partial hospitalization psychiatric services. He was further ordered to pay $43.5 million in restitution and to forfeit all proceeds from the fraudulent scheme

Associate Attorney General Tony West today announced $3 million dollars in grants from the Office on Violence Against Women (OVW) to increase local and tribal capacity to prosecute crimes of violence against women and provide services to victims of sexual assault, domestic violence and stalking in the Bakken Region of North Dakota and Montana

An owner of an electrical contracting company pleaded guilty today to falsifying disclosure documents required under the Employee Retirement Income Security Act (ERISA), by intentionally under-reporting hours worked by employees to avoid contractually required contributions to employee benefit plans.

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.

Attorney General Eric Holder released the following statement Wednesday on the resignation of U.S. Attorney Jenny Durkan for the Western District of Washington:

The United States has filed two complaints under the False Claims Act against Michigan neurosurgeon Dr. Aria Sabit, spinal implant company Reliance Medical Systems, two Reliance distributorships—Apex Medical Technologies and Kronos Spinal Technologies—and the companies’ owners, Brett Berry, John Hoffman and Adam Pike.

The Department of Justice announced today that it has entered into a settlement agreement with the School District of Philadelphia that resolves a religious accommodations lawsuit filed in March 2014. In its lawsuit, the United States alleged that the school district violated Title VII of the Civil Rights Act of 1964 (Title VII) by failing to accommodate the religious beliefs, observances and/or practices of Siddiq Abu-Bakr, a school police officer who is Muslim, and similarly-situated employees who maintain a beard longer than one-quarter inch for religious purposes.

William P. Danielczyk, theformer head of a Virginia-based defense contracting company, was sentenced today to serve 18 months in prison for failing to collect and pay more than $2.2 million in employee payroll taxes and engaging in theft of more than $186,000 from an employee pension plan.

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

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

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 …

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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.

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.

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.

The U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.'s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions. The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms.

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.

Valensa International announced today a joint venture agreement between Valensa’s parent company EID Parry and Synthite Industries Ltd., expanding plans to lead development and distribution of value-added microalgae extracts.

Baby Boomers, Gen X and Millennials are key consumer target groups for marketers, with three different sets of needs and buying propensities; it’s important that brands define their unique selling propositions.

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

Nutrition 21, LLC has announced its Nitrosigine® is now featured in EVERTRAIN PRE, a recently launched pre-workout supplement designed to provide athletes with sustained energy, superior focus and increased endurance.

Exercise is good for the immune system but, as with anything, balance is key and this is especially the case when it comes to matching the type and level of activity with the right nutrition, as will be expertly explained in NutraIngredients' upcoming webinar.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

Chinese Taipei has voluntarily contributed USD 550,000 in funding to support APEC initiatives that advance regional economic integration and inclusive sustainable growth across the Asia-Pacific.

Regional cooperation key to containment and rebound

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.

Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars…

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