Kathryn Darlene Coryell, a Fresno, California, resident, pleaded guilty yesterday to conspiracy to defraud the Internal Revenue Service (IRS) and wire fraud, announced Deputy Assistant Attorney General Ronald A. Cimino for the Justice Department’s Tax Division and U.S. Attorney Melinda Haag for the Northern District of California

George Washington himself conceived and designed them, but it was Mount Vernon’s other residents -- the hundreds of men and women who worked for Washington -- it was their hands that built and tended this splendor. Like you, those men and women had origins that stretched around the globe. They were Christians and Muslims; Africans and Europeans.

A Southern California man who was convicted at trial of conspiracy to commit health care fraud, six counts of health care fraud and six counts of aggravated identity theft was sentenced to serve 121 months in prison today in federal court in Los Angeles

Two Long Beach, California, men pleaded guilty today to conspiracy charges arising from a sex trafficking scheme that exploited adult women for prostitution. Roshaun Nakia Porter, 39, and Marquis Monte Horn, 35, both pleaded guilty before Judge Josephine L. Staton in the U.S. District Court for the Central District of California to conspiring to engage in sex trafficking by force, fraud and coercion

The Justice Department announced today that it has released a Best Practices Guide to Reform HIV-Specific Criminal Laws to Align with Scientifically-Supported Factors . This guide provides technical assistance regarding state laws that criminalize engaging in certain behaviors without disclosing known HIV-positive status

Nathan Stoliar, 64, of Australia, pleaded guilty in federal court in Las Vegas today to five felonies for his role in multiple schemes, worth in excess of $41 million, to generate fraudulent biodiesel credits and to export biodiesel without providing biodiesel credits to the United States as required by law

I am honored to join you in this pursuit. I congratulate you, once again, on this extraordinary occasion. And I thank you for allowing me to share it with you.

The Justice Department today announced an agreement with the owners and operators of Woodland Garden Apartments in Fremont, California, to settle allegations of discrimination against families with children. Under the consent order, which must still be approved by the U.S. District Court for the Northern District of California, the defendants are required to pay $77,500 to the victims of their discrimination and an additional $2,500 to the government as a civil penalty

Kenny E. Toy, 54, the former Afloat Programs Manager at the United States Navy Military Sealift Command, was sentenced today to serve 96 months in prison for receiving bribes

On July 31, 2014, a federal jury in Los Angeles found that the former owner of a durable medical equipment (DME) supply company located in Carson, California, was guilty of health care fraud charges relating a 10-year scheme in which Medicare was fraudulently billed more than $8 million for DME that was not medically necessary

A former employee of a government contracting company was sentenced today to 36 months in prison to be followed by three years of supervised release for conspiracy to bribe public officials at the United States Navy Military Sealift Command in exchange for favorable treatment in connection with U.S. government contract work

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

Adam Michael Webber, of Salt Lake County, Utah, was indicted on Friday by a federal grand jury in the District of Utah, the Justice Department announced. The indictment, which was made public today, charges Webber with one count of dealing in firearms without a license, one count of smuggling goods from the United States and six counts of filing false tax returns

A former Iowa State Senator pleaded guilty today to concealing payments he received from a presidential campaign in exchange for switching his support and services from one candidate to another and to obstructing a subsequent investigation into his conduct.

A federal court has permanently barred a Rancho Santa Margarita, California, man from promoting and selling an alleged nationwide tax scheme that involved using welfare benefit plans to unlawfully increase and accelerate tax deductions and avoid income taxes.

A federal grand jury in San Francisco returned an eight-count indictment against five real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced

A federal grand jury in San Francisco returned three multi-count indictments against eleven real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced

A Northern California real estate investor has agreed to plead guilty for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Northern California, the Department of Justice announced

A Northern California real estate investor has agreed to plead guilty for his role in bid rigging and fraud conspiracies at public real estate foreclosure auctions in Northern California, the Department of Justice announced

A Las Vegas man pleaded guilty today to conspiracy for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors

A Las Vegas man was sentenced today to 60 months in prison for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors

NORFOLK, Va

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.

Equal pay, migrant workers, and maternal health are the issues highlighted by the finalists of the inaugural APEC Healthy Women, Healthy Economies Research Prize.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous For device-lead drug combination products, is there any difference in the quality (grade) of API used compared to a pure drug product? The cGMP guidance for combination products does not seem to specify, and since drug claims cannot be made on device-lead drug combination products, it was not clear what quality of drug is required. Thank you!

From : Communities>>Regulatory Open Forum
​I doubt FDA would have any willingness to change the requirements or expectations for a drug product based on whether it is in a strictly drug product versus in a combination product.  The fact also that there is not a published allowance for this is further evidence that FDA expects that the drug will meet the requirements as expected for drug products without providing any allowed changes or classes of changes.  Remember, FDA expects that drug products meet specific requirements.  Things like [More]

• 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

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.

Posted by Roger Bate The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa. It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study [...]

Posted by Roger Bate India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to li [...]

Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...]

Posted by Roger Bate A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations. Compulsory licensing (CL) allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported. In some cases the price cuts of CL can be substantial, notably in Thailand, where key medicines dropped to about 10% of the original price. But researchers (in [...]

by Marshall Allen

The links to the viral video “Plandemic” started showing up in my Facebook feed Wednesday. “Very interesting,” one of my friends wrote about it. I saw several subsequent posts about it, and then my brother texted me, “Got a sec?”

My brother is a pastor in Colorado and had someone he respects urge him to watch “Plandemic,” a 26-minute video that promises to reveal the “hidden agenda” behind the COVID-19 pandemic. I called him and he shared his concern: People seem to be taking the conspiracy theories presented in “Plandemic” seriously. He wondered if I could write something up that he could pass along to them, to help people distinguish between sound reporting and conspiracy thinking or propaganda.

So I watched “Plandemic.” I did not find it credible, as I will explain below. YouTube, Facebook and Vimeo have since removed it from their platforms for violating their guidelines. Now it’s available on its own site.

Sensational videos, memes, rants and more about COVID-19 are likely to keep coming. With society polarized and deep distrust of the media, the government and other institutions, such content is a way for bad actors to sow discord, mostly via social media. We saw it with Russia in the 2016 election and we should expect it to continue.

But what surprised me is how easily “Plandemic” sank its hooks into some of my friends. My brother also felt alarmed that his own church members and leaders in other churches might be tempted to buy into it.

The purpose of this column is not to skewer “Plandemic.” My goal is to offer some criteria for sifting through all the content we see every day, so we can tell the difference between fair reporting and something so biased it should not be taken seriously.

Here’s a checklist, some of which I shared with my friends on Facebook, to help interrogate any content — and that includes what we publish at ProPublica.

Is the Presentation One-Sided?

There’s never just one side to a story. I mentioned this point in 2018 when I wrote about my faith and the biblical basis for investigative reporting. One of my favorite Proverbs says, “The first to state his case seems right until another comes and cross-examines him.” So a fair presentation should at least acknowledge opposing points of view.

I didn’t see this in “Plandemic,” so I called the filmmaker, Mikki Willis, who is also the film’s narrator, to ask him whether I had somehow missed the other side of the argument. I had not. “The other side of the argument plays 24/7 on every screen in every airport and on every phone and in every home,” Willis said. “The people are only seeing one side of the story all the time. This is the other side of the story. This is not a piece that’s intended to be perfectly balanced.”

I asked Willis if it was fair to call his film “propaganda,” which the Oxford dictionary defines as “information, especially of a biased or misleading nature, used to promote or publicize a particular political cause or point of view.”

He said he doesn’t feel there’s anything misleading in his film, but otherwise the definition fits. And based on that definition he feels 100% of news reporting is propaganda. “What isn’t propaganda these days?” he asked. “In that sense, what we’re doing is fighting fire with fire.”

Is There an Independent Pursuit of the Truth?

The star of “Plandemic,” medical researcher Judy Mikovits, is controversial. The magazine Science reports that it published and then retracted one of her papers in 2011. A search warrant provided to ProPublica by one of her former attorneys shows she was fired from her position at Whittemore Peterson Institute, a research center in Nevada, in September 2011. Then she allegedly stole notebooks and a laptop computer from the Institute, the search warrant said, leading to an arrest warrant for alleged possession of stolen property and unlawful taking of computer data. She was arrested on Nov. 18, 2011, but denied wrongdoing. The charges were dropped.

But “Plandemic” ignores or brushes past these facts and portrays her as an embattled whistleblower. “So you made a discovery that conflicted with the agreed-upon narrative?” Willis says to Mikovits, introducing her as a victim. “And for that, they did everything in their powers to destroy your life.”

A typical viewer is not going to know the details about Mikovits’ background. But as the primary source of controversial information being presented as fact, it’s worth an online search. The fact-checking site PolitiFact details her arrest and criminal charges. Clearly, there’s more to her story than what’s presented in “Plandemic.” That should give us pause when we assess its credibility.

Is There a Careful Adherence to the Facts?

In “Plandemic,” Willis asks Mikovits about her arrest: “What did they charge you with?”

“Nothing,” she replies. “I was held in jail, with no charges.”

Being charged with a crime is one of those concrete facts that we can check out. Science magazine reported Mikovits’ arrest and felony charge. I also found a civil lawsuit she filed against the Whittemore Peterson Institute in 2014 in the U.S. District Court for the Southern District of California. “Mikovits was arrested on criminal charges…” her complaint says in the case, which was eventually dismissed.

I asked Willis about the apparent discrepancy, where she said in his film that she wasn’t charged, when court documents show that she was charged. After my inquiry, he said he spoke to Mikovits and now feels it is clear that she meant that the charges were dropped.

I tracked down Mikovits and she said what she meant in the film is that there were no charges of any type of wrongdoing that would have led to her being charged with being a fugitive from justice. She admitted that all the controversy has been hard for her to sort out. “I’ve been confused for a decade,” she told me. She said she would try to be more clear in the future when she talks about the criminal charge: “I’ll try to learn to say it differently,” she said.

This underscores the importance of careful verification, and it distinguishes the craft of journalism from other forms of information sharing. People often speak imprecisely when they’re telling their stories. It’s our duty to nail down precisely what they do and do not mean, and verify it independently. If we don’t, we risk undermining their credibility and ours. That’s in part why we at ProPublica and many other journalists often link directly to our underlying source documents, so you can verify the information yourself.

Are Those Accused Allowed to Respond?

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is one of the nation’s leaders in the response to the coronavirus. In “Plandemic,” Mikovits accuses Fauci of a cover-up and of paying off people who perpetrate fraud, among other things. PolitiFact found no evidence to support the allegations against Fauci.

Every time I write a story that accuses someone of wrongdoing I call them and urge them to explain the situation from their perspective. This is standard in mainstream journalism. Sometimes I’ve gone to extreme lengths to get comments from someone who will be portrayed unfavorably in my story — traveling to another state and showing up at their office and their home and leaving a note if they are not there to meet me. “Plandemic” doesn’t indicate whether the filmmakers reached out to Fauci for his version of the story. So I asked Willis about it. “We did not,” he told me.

Are All Sources Named and Cited, and if Not, Is the Reason Explained?

All sources should be identified, with their credentials, so viewers can verify their expertise or possible biases. If they can’t be for some reason, then that should be explained. “Plandemic” features unnamed people in medical scrubs, presented as doctors, saying they’re being wrongly pressured to add COVID-19 on people’s death certificates or are not being allowed to use the drug hydroxychloroquine to treat patients. But the speakers are not named, so we can’t really tell who they are, or even if they are doctors at all. That makes it impossible to tell if they are credible.

I asked Willis why he didn’t name those people. He told me he was in a hurry to release the 26-minute version of “Plandemic,” but the doctors will be named in the final version. “We should have done that,” he said.

Does the Work Claim Some Secret Knowledge?

“Plandemic” calls itself a documentary that reveals “the hidden agenda behind COVID-19.” We are in the midst of a global pandemic where few people in the world can figure out what is happening or the right way to respond, let alone agendas. We have almost every journalist in the country writing about this. And if the truth about a conspiracy is out there, many people have an incentive to share it. But “Plandemic” would like us to think it’s presenting some exclusive bit of secret knowledge that is going to get at the real story. That’s not likely.

Plus, to be honest, there were so many conspiratorial details stacked on top of each other in the film I couldn’t keep them straight. When I spoke to Willis I told him I was having a hard time understanding his point. Then I took a stab at what I thought was the main thrust of his argument. “Are you saying that powerful people planned the pandemic and made it happen so they could get rich by making everyone get vaccines?” I asked.

It turns out Willis isn’t sure either. “We’re in the exploratory phase,” he told me. “I don’t know, to be clear, if it’s an intentional or naturally occurring situation. I have no idea.”

Then he went on to say that the pandemic is being politicized and used to take away our civil liberties and leverage other political policies. “Certain forces” have latched onto the situation, he said. “It’s too fishy.”

He had me at, “I have no idea.” That sums it up. This is a vast pandemic and massive catastrophe. Our country wasn’t prepared for it, and the response by our top leaders has been disjointed. We’re restricted to our homes. Many people have lost their jobs and some are afraid or sick or dying. That makes us vulnerable to exploitation by people who will present inaccurate or intellectually dishonest information that promises to tell us the truth.

Perhaps “Plandemic” is guilty of sloppy storytelling, or maybe people really do believe the things they’re saying in the video. Or perhaps they’re being intentionally dishonest, or it’s a biased connecting of the dots rooted in personal and professional grievances. I don’t know because I can’t get inside their heads to judge their motives.

Ultimately, we’re all going to need to be more savvy consumers when it comes to information, no matter how slickly it’s presented. This may be but a signal of what’s to come in the run-up to the 2020 presidential election, when memes and ads of unknown origin come across our social media feeds. There are standards for judging the credibility of the media we take in every day, so let’s apply them.

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Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. 

To read the whole article click on the headline

March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […]

Eli Lilly has teamed with China’s Junshi Biosciences in the U.S., marking the company's second COVID-19 pact to develop neutralizing antibodies against the virus. It promises to be a faster approach than designing a new small-molecule drug would be, but getting from idea to an effective product may not be so simple.

Tough times at Orchard Therapeutics as it swings the ax across staffers and facilities, phases in new pipeline advances and reduces interest in others.

Consumers arenât just looking for custom-made approaches any more, theyâre expecting it. As technology advances, more companies are offering custom nutritional solutions.

The results provide priceless information on ancestry and predispositions to various illnesses.

Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains.

Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday.

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.

California DMV will reopen 25 field offices after shutdown

Kings County Supervisor Doug Verboon said the outbreak at Central Valley Meat Company in Hanford accounts for nearly two-thirds of the coronavirus cases in the rural county, which has a total of 211 reported cases.

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.

Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week.

Newsom cited the case when asked why personal services, such as nail salons, must remain closed.