"The issues you’re discussing here at this summit – the intersection of drugs and crime, gang and youth violence, the future of juvenile justice – are all issues the Department of Justice and my office, the Office of Justice Programs, are working diligently to address," said Acting Assistant Attorney General Leary.

Lina Rodriguez, 34, was sentenced today in the U.S. District Court for the Southern District of Florida to serve 72 months in prison, followed by 24 months of supervised release, for operating and facilitating the operation of an Internet-pharmacy business that illegally shipped over $1.5 million of pharmaceuticals since July 2007 to U.S. and overseas purchasers.

The Justice Department announced today that the United States has filed a second civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers.

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA Inc., a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty today to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India.

Aurelio Cano Flores, a Mexican national and high ranking member of the Gulf Cartel, was sentenced today to serve 35 years in prison for conspiring to import multi-ton quantities of cocaine and marijuana into the United States.

Michael P. Jackson, 40, of Carmi, Ill., was sentenced today in the U.S. District Court for the Southern District of Florida to serve 72 months in prison for selling the prescription drug known as Adderall.

A federal jury in the Eastern District of Pennsylvania that voted in favor of death for a North Philadelphia drug kingpin, Kaboni Savage, today voted in favor of life for a co-defendant, Steven Northington. Savage was sentenced to death last week by U.S. District Court Judge R. Barclay Surrick.

Acting Assistant Attorney General Stuart F. Delery announced today that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals.

While incarceration is a necessary part of the strategy for ensuring public safety, we know it is not the only answer in every case -- especially for the low-level drug offender. If any of us hope to change the behavior of our criminal population – and make our communities safer – we must make the investment to treat individuals with substance use disorders and others in need of help as a part of the criminal justice system.

Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA).

Christian Fernando Borda, a major narcotics trafficker aligned with paramilitary groups in Colombia, was sentenced today to serve 25 years in prison for conspiring to import ton-quantities of cocaine into the United States, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and Administrator Michele M. Leonhart of the Drug Enforcement Administration (DEA).

Southfield, Mich., resident Bashar Saroki pleaded guilty to filing a false tax return and selling drug paraphernalia, the Justice Department and the Internal Revenue Service (IRS) announced today.

The government filed suit in the U.S. District Court for South Dakota against Dakota Laboratories LLC and its owner, Charles L. Voellinger, Sr., to block them from violating the Food, Drug and Cosmetic Act (FDCA) in connection with their alleged violations of Current Good Manufacturing Practices (CGMP).

Jose Maria Corredor-Ibague, aka “Boyaco,” a high-level drug trafficker and supporter of the Fuerzas Armadas Revolucionarias de Colombia (FARC), has been sentenced in Washington, D.C., to serve 194 months in prison. Corredor-Ibague was the first person in the nation to be indicted under the federal narco-terrorism statute, which became law in March 2006.

A member of the Playboy Bloods street gang was sentenced today to life in prison for the retaliation murder of a man in November 2004 and the armed robbery of a Henderson, Nev., casino in 2002, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and U.S. Attorney Daniel G. Bogden of the District of Nevada.

Gilberto Lerma Plata, a former commander of the Mexican State Police and member of the Gulf Cartel, was sentenced today to serve 151 months in prison for conspiring to import multi-ton quantities of marijuana into the United States, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and Administrator Michele M. Leonhart of the Drug Enforcement Administration (DEA).

Acting U.S. Attorney A. Lee Bentley III and Acting Assistant Attorney General Jocelyn Samuels of the Civil Rights Division today announced the conviction of Andrew Blane Fields, 62, of Lutz, Fla., in the Middle District of Florida on charges of possession with intent to distribute controlled substances, namely Oxycodone, Dilaudid and Morphine, and sex trafficking by force, fraud and coercion.

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.

As we move forward with these and other reforms, we will continue to stand and work alongside you, drawing upon your experience, relying on your expertise, and depending on your engagement to refine and strengthen each new proposal.

U.S. District Court Judge Kim R. Gibson of the Western District of Pennsylvania has entered a consent decree of permanent injunction against Metzler & Sons LLC and Pleasant View Farms Inc., the Justice Department announced today.

A former Puerto Rico Department of Corrections officer was sentenced today to serve 811 months in prison for his role in providing armed security for three drug transactions.

Bashar Saroki, a resident of Southfield, Mich., was sentenced today in the U.S. District Court for the Eastern District of Michigan to serve 30 months in prison to be followed by one year of supervised release, the Justice Department and the Internal Revenue Service announced.

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.

In testimony delivered before the U.S. Sentencing Commission Thursday, Attorney General Eric Holder endorsed a proposed change to the Federal Sentencing Guidelines that would reserve the harshest penalties for the most serious drug offenders.

I believe that the only real, sustainable choice – the only safe and humane option – is the one that broadens opportunity and widens the path to success. Each of you is helping to lead us in that direction, and we are marching forward with you. And I am optimistic that we will continue to see an America that is safer, healthier, and more just.

U.S. Attorney General Eric Holder—who testified before the U.S. Sentencing Commission last month in support of a proposal to reduce the federal sentencing guidelines for low-level, nonviolent drug offenders—released the following statement Thursday in response to the Commission voting to formally adopt those changes.

I know the paths that brought you to this courtroom have been anything but easy. But each of you is here today because you’ve decided not to let past choices – and challenges – define you. You’re working hard to stay on a constructive path. And I am proud of every one of you.

Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use.

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.

A former private security guard was sentenced in the District of Puerto Rico today for his role in providing armed security for a drug transaction.

Attorney General Eric Holder announced Tuesday that the Justice Department would formally support a proposal under consideration by the U.S. Sentencing Commission to allow certain individuals serving time in federal prison for nonviolent drug offenses to be eligible for reduced sentences.

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 Department of Justice today announced the filing of a civil lawsuit against Laclede Inc. and its president, Michael A. Pellico, seeking to stop the distribution of over-the-counter vaginal drug products that the company makes and sells nationwide

An Illinois man, who previously pleaded guilty to trafficking in counterfeit goods and introducing counterfeit drugs into interstate commerce in violation of the Food, Drug and Cosmetic Act, was sentenced today to serve 41 months in prison

Attorney General Eric Holder today released the following statement regarding the U.S. Sentencing Commission vote approving retroactivity of sentence reductions for drug offenses

On the second day of his federal jury trial, a Las Vegas Playboy Bloods street gang member pleaded guilty today to racketeering and drug charges, announced U.S. Attorney Daniel G. Bogden of the District of Nevada and Leslie R. Caldwell, Assistant Attorney General of the Justice Department’s Criminal Division

Kelvin L. Brown, aka “Doom,” 34, of Newport News, Virginia, was convicted yesterday by a federal jury of participating in a drug conspiracy in the Newport News area, from the early 2000’s through September 2013. Brown was also convicted of distribution of cocaine, possession with intent to distribute cocaine, two counts of possession of firearms in furtherance of a drug trafficking crime and felon in possession of a firearm

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

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.

Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.

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.

The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

Today's Daily Dose brings you news about the revised FDA decision date for Bristol Myers' CAR T cell therapy for refractory large B-cell lymphoma; Enanta Pharma's primary biliary cholangitis trial results; MacroGenics' anticipated clinical data read-outs and regulatory event for this year and Trovagene's name change.

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.

Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results.

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.

The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

The perennial drug pricing debate has reached a fever pitch, as loud as it’s ever been over the past few decades. Politicians on both sides are bashing the drug industry with the typical talking points about exorbitant prices, countered of

The post Venturing A Perspective On The Drug Pricing Debate appeared first on LifeSciVC.

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]