A third senior U.S. Navy official has been charged in a complaint unsealed today with accepting prostitutes, luxury travel and $100,000 cash from a foreign defense contractor in exchange for classified and internal U.S. Navy information, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and U.S. Attorney Laura E. Duffy of the Southern District of California.

A federal jury today found Robroy MacInnes, 54, of Inverness, Fla., and Robert Keszey, 47, of Bushnell, Fla., guilty of conspiracy to traffic in state and federally protected reptiles. MacInnes also was convicted of trafficking in protected timber rattlesnakes in violation of the Lacey Act.

Caremark LLC, a pharmacy benefit management company (PBM), will pay the government and five states a total of $4.25 million to settle allegations that it knowingly failed to reimburse Medicaid for prescription drug costs paid on behalf of Medicaid beneficiaries, who also were eligible for drug benefits under Caremark-administered private health plans.

Three Georgia men have been charged in a 51-count indictment for their alleged participation in fraud and corruption schemes at the Marine Corps Logistics Base (MCLB) in Albany, Ga., resulting in the loss of millions of dollars to the United States government.

Four current and former employees of International Adoption Guides Inc. (IAG), an adoption services provider, have been indicted by a grand jury in South Carolina for allegedly conspiring to defraud the United States in connection with IAG’s adoption services in Ethiopia.

Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration.

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.

Kristopher Michael Montemayor, a county commissioner for Precinct 1 of the Webb County Commissioners Court in Texas, was arrested today on charges of bribery.

Now more than ever, we are fighting global corruption on multiple fronts and in real time. We are going after corrupt individuals and corporations using all of the investigative and legal tools at our disposal.

Deputy Attorney General James M. Cole will preside over the National Crime Victims’ Rights Service Awards ceremony 2 p.m. Wed., April 9, honoring ten individuals and programs for exceptional perseverance and innovation in advancing crime victims’ rights.

Allen Wayne Densen Morgan, 29, of Munford, Ala., was sentenced in the U.S. District Court for the Northern District of Alabama to serve 72 months in prison to be followed by three years supervised release for attempting to hire members of the Ku Klux Klan to torture and murder his African-American neighbor.

"Each of the 2014 grant recipients are doing amazing work – day in and day out they are changing the lives of the most vulnerable residents in the District of Columbia. And they are strengthening our nation’s legal community," said Principal Deputy Director Hanson

Baptist Health System Inc. (Baptist Health), the parent company for a network of affiliated hospitals and medical providers in the Jacksonville, Florida, area, has agreed to pay $2.5 million to settle allegations that its subsidiaries violated the False Claims Act by submitting claims to federal health care programs for medically unnecessary services and drugs.

And it’s not enough until the circle of opportunity and equality is so wide – and so accessible – that the American Dream is available to everyone with the heart to dream it.

Kristopher Michael Montemayor, a county commissioner for Precinct 1 of the Webb County Commissioners Court in Texas, pleaded guilty to bribery today

You know as well as anyone that the challenges we face are daunting. You’ve shown us that, as we seek to address the problem of substance abuse, it makes sense to focus on the most dangerous types of drugs. And right now, few substances are more lethal than prescription opioids and heroin.

The Justice Department today filed a status report with the United States District Court for the Western District of Pennsylvania updating the court on the progress in disrupting the Gameover Zeus botnet and the malicious software known as Cryptolocker

"Because if a government of, by and for the people means anything at all, it means that a ballot has the power to give equal voice to the high and the low; the weak and the strong; those at the bottom as well as the top. It means that in the polling place, the line is just as long for the richest among us as it is for those who often work the hardest but have the least."

A former foreign program director of International Adoption Guides Inc. (IAG), an adoption agency, pleaded guilty today to conspiring with others to defraud the United States by paying bribes to foreign officials and submitting fraudulent documents to the State Department for adoptions from Ethiopia

Political consultant Gregory Naylor, 66, of Philadelphia, pleaded guilty today to making false statements to federal agents and misprision of a felony in connection with his role in attempting to conceal two campaign finance-related fraud schemes

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.

A federal jury returned guilty verdicts today against former Virginia Governor Robert F. McDonnell and former First Lady of Virginia Maureen G. McDonnell for participating in a scheme to violate federal public corruption laws.

Calling prescription drug addiction an “urgent and growing threat” to our nation’s public health, Attorney General Eric Holder on Monday announced a new Drug Enforcement Administration(DEA) regulation that would allow pharmacies, hospitals, clinics, and other authorized collectors to serve as authorized drop-off sites for unused prescription drugs.

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.

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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High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.

Bergstrom Nutrition, manufacturer of OptiMSM®, a branded form of methylsulfonylmethane (MSM), recently published an article detailing how the small intestine absorbs MSM, particularly in relation to sulfur.

Rousselot, the collagen-based ingredients producer, has revealed a new study which it says provides important answers surrounding the bioavailability of collagen peptides and the modifications they undergo during digestion.

The impact of corruption is far-reaching and devastating, especially for women.

Business leaders from around the Asia-Pacific met in Sydney last week to discuss the year ahead

Research Promoting Women’s Health to Receive $20,000 Prize

The first Senior Officials Meeting for APEC Malaysia 2020 begins

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partenships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements.



Strategic Partnerships in Big Pharma: Implications for the Rest
Advantages for one segment of the industry can introduce disadvantages for another.  Alliances among the large players increase competition for top-drawer CRO resources. Smaller sponsors may find it more difficult to receive the quality of service and level of commitment they might otherwise expect.  A large CRO is likely to assign their most talented personnel to projects associated with their strategic partners.  And if a partner study were to run into trouble, it would be hard to fault a CRO for pulling experienced staff members off a smaller project in order to help out with the big client.  Though a reputable CRO wouldn’t jeopardize the relationship with the smaller client, their responsiveness to routine requests might suffer.  It might take longer to get a question answered, receive requested documentation, making the job of vendor oversight difficult.

Though selecting a large, well-established CRO at the outset may have seemed like the safe bet, what do you do if you’re a small sponsor or biotech start-up who is dissatisfied with the level of service you’re receiving?

“Let’s Bring It In-house.”
Put off by a negative experience, many companies decide to curtail outsourcing, and bring functions like monitoring and project management in-house.

This response is understandable, but it rarely goes well.  There’s good reason to outsource study functions to a CRO, especially if you’re small, or new, or both.  Mid-study is a terrible time to realize you’re in over your head.  You may find it difficult to contract with the service providers you want in the timeframe you need them.  Services you would have preferred be performed by a single company may now have to be farmed out piecemeal, which has the overhead of multiple contracts and makes vendor oversight more difficult to manage.  You don’t have time to go through a thorough qualification process.  You’re not in a good bargaining position; you’re trying to buy a new car after they’ve towed away your old one.  And now you have to rely on your new service provider(s) – the ones who may not be your first choice, whom you had to choose in haste, whom you didn’t get to thoroughly vet – to jump in midstream and pick up a study that is already in trouble.

Options for Small Sponsors and Start-ups
So what’s the answer?  You have several good options we’ve seen work well for smaller organizations.

(1) Go smaller.  Look beyond traditional outsourcing choices and consider selecting smaller vendors who may well be in a better position to focus on individual projects and give priority to shorter term engagements.  After all, a project that’s small to a big CRO will be comparatively big to a small CRO.

(2) Go long-term.  Consider establishing strategic partnerships of your own.   Doing so would increase the expertise and technology to which you’d have ready access, and could extend your global reach.

(3) Go big, but go vigilantly.  There’s a reason companies hire big, reputable CROs.  ‘Big’ means the CRO has an impressive set of resources at its disposal.  ‘Reputable’ means it has a proven record of successfully completing studies, producing reliable data, and preserving subject safety.  Smaller sponsors can still take advantage of everything a big CRO offers if they can commit to conducting very strict vendor oversight.  They need to closely monitor the quality of the work the CRO performs, frequently assess adherence to the many written study plans, and make sure deadlines are being met.  Service contracts should guarantee a certain level of responsiveness (by specifying maximum turn-around times, for example), especially for those requests that enable these oversight activities.


Qualification is Key
While the key to Option 3 is effective vendor management, the key to Options 1 and 2 is effective vendor qualification.  Resources are tight in a small company, so you need to direct them where your exposure is greatest, where they’ll do the most good.  What could be more essential to the success of your study than choosing the right company to conduct it?   Many sponsors conduct on-site vendor audits.  That’s good.  That’s necessary.  But it’s not sufficient.  To consistently choose the best possible CRO for your study, sponsors need to:

• Formally document and maintain vendor selection criteria and qualification process
• Form selection committees that represent all sides of your business – finance, contracting, operations, finance, QA, data management, pharmacovigilance, biostatistics, etc.
• Conduct on-site audits with well-trained, well-prepared QA auditors
• Track the resulting CAPA activities
• Ensure outstanding issues are resolved before the contract is signed
• Periodically re-evaluate vendors to make sure they can continue to deliver the same level of quality they’ve delivered in the past

Strategic partnerships among large companies have reshaped the research environment for industry players of every size.  Small and mid-sized companies who take the time to review current outsourcing arrangements, assess alternative models, and thoroughly qualify new vendors and partners will fare the best.

Photo Credit: FreeImages.com/Svilen Milev

• 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

NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background.

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A novel combination of two Lactobacillus paracasei strains may increase absorption of key amino acids in plant proteins, according to a new placebo-controlled, randomized, double-blind, multicenter, crossover study.

Ethan Perlstein, founder of Perlstein Lab, asked a question on Twitter and got some great answers from David Grainger, partner at Index Ventures and Katrine Bosley, CEO of Editas Medicine. (You can read the whole thread by clicking through.) @LifeSciVC @sciencescanner @ksbosley @scientre what's the burn rate distribution of biotech NewCos in for the first year of

By Karla L. Palmer —

U.S. and U.K. intel agencies are reviewing the private report, but intel analysts examined and couldn't confirm a similar theory previously.

ExRobotics B.V., a Netherlands-based developer of robotics technology for hazardous environments, and Yokogawa Electric Corporation (TOKYO: 6841), a global provider of industrial automation, control, and measurement technology, announce the signing of a licensing agreement that will enable Yokogawa to sell and deploy ExRobotics' inspection robot hardware and software platforms worldwide.

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of Exaquantum R3.20, an enhanced version of its plant information management system (PIMS) software package in the OpreX Asset Operations and Optimization family.

Persons with disabilities would be provided six months’ pension in advance for adapting their homes as per their requirement.