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Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO

Trovagene (NASDAQ: TROV), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational […]




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Steven T Gill returns to Alimera as VP, Thought Leader Engagement

Ophthalmology specialist Alimera Sciences has announced that Steven T Gill is to return to the company in the newly created role of Vice President, Thought Leader Engagement.

Gill had previously served at Alimera as its Senior Director, Thought Leader Liaison, before leaving the company for Novartis, where he most recently held the position of Associate Director, Thought Leader Liaison at Novartis US.

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EPS taps CluePoints for trial management solution

The Japanese pharma development firm will harness risk-based quality management solutions to help sponsors improve trial quality and safety.




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Pharmaseal adds eTMF document storage to trial platform

The company has incorporated electronic trial master file document storage capabilities to its Engility clinical trial management platform.




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NEW: The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

I am pleased to announce our new 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, available for purchase and immediate download.
We’re offering special discounted pricing if you order before March 22, 2020.

The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers is a truly unique resource. With 203 proprietary charts, exhibits, and data tables, this 11th edition provides a comprehensive, fact-based, and non-partisan tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system.

The full document clocks in at 374 pages. I can safely say there is nothing else available that comes close to this report.

The chart below illustrates the depth and breadth of the 2020 edition. The numbers indicate the report chapter that corresponds to, explains, and analyzes each channel flow.

[Click to Enlarge]

Below, you can read more info and some behind-the-scenes tidbits.

P.S. If you would like to pay by corporate purchase order or check, please email Tamra Feldman. If you preordered the report, you should have already received an email with download instructions. Please contact us if you did not receive the email.
Read more »
        




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A Consistent Approach to Risk Based Quality Management: Collaboration is Key

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to...




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European Medicines Agency’s review of Picato finds its risks outweigh its benefits

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.




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Sanofi's Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.




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Glutagenic Virus Protection Kit

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.




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COVID-19 leading to shortage of orphan drugs in Russia

The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in…



  • Anti-virals/Coronavirus/Focus On/From our correspondent/Hydroxychloroquine/In Depth/Pharmaceutical/Public health/Rare diseases/Russia/Russian market

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Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT

Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports.




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Imprisoned Spy and His Son Indicted on Charges of Acting as Russian Agents and Money Laundering

A federal indictment was unsealed today in U.S. District Court for the District of Oregon charging Harold James Nicholson, 58, of Sheridan, Ore., and Nathaniel James Nicholson, 24, of Eugene, Ore., with two counts of Conspiracy, one count of Acting as Agents of a Foreign Government, and four counts of Money Laundering.



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U.S. Recovers $19 Million from AMEC Construction Management to Settle Litigation Regarding Fraud, False Claims, Kickbacks & Re-Procurement Costs on Federal Construction Contracts

The United States has recovered more than $19 million from AMEC Construction Management Inc. (ACMI) to resolve allegations of fraud, false claims and kickbacks on four General Services Administration (GSA) construction contracts, as well as litigation over claims by the GSA for excess re-procurement costs incurred by GSA after it terminated ACMI’s contract to build the Thomas F. Eagleton United States Courthouse in St. Louis, Missouri. ACMI was formerly known as Morse Diesel International Inc.



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N.J. Electrical Company Employee Pleads Guilty to Defrauding the Environmental Protection Agency at Superfund Site

An employee of a Sewell, N.J., company that provided temporary electrical utilities pleaded guilty today to participating in a fraud conspiracy at an Environmental Protection Agency (EPA)-designated Superfund site in New Jersey.



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U.S. Border Patrol Agent Indicted on Federal Civil Rights Charge for Assault in Federal Detention Facility

A U.S. Border Patrol agent has been indicted by a federal grand jury in Tucson, Ariz., on federal civil rights charges related to an alleged assault on a detainee at a federal detention facility. The two-count indictment, returned on March 11, 2009, alleges that on May 10, 2006, Eduardo Moreno violated the civil rights of a federal detainee by assaulting and causing bodily injury to the individual while Moreno was on duty at the U.S. Border Patrol processing facility in Nogales, Ariz.



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General Maritime Management (Portugal) Fined $1 Million for Enviromental Crimes

A federal judge in Corpus Christi, Texas, has sentenced General Maritime Management (Portugal), the operator of a fleet of tanker vessels, and two crewmembers of the motor tanker Genmar Defiance for making false statements to the U.S. Coast Guard and failing to maintain an accurate Oil Record Book designed to prevent pollution of the world’s oceans as required by United States and international law.



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Federal, State Partners Announce Multi-Agency Crackdown Targeting Foreclosure Rescue Scams, Loan Modification Fraud

As homeowners and communities throughout the country continue to face devastating consequences from the deep contraction in the economy and the housing market, the Obama Administration today announced a new coordinated effort across federal and state government and the private sector to target mortgage loan modification fraud and foreclosure rescue scams that threaten to hurt American homeowners and prevent them from getting the help they need during these challenging times.



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United States Announces Largest Settlement Under Environmental Protection Agency’s Audit Policy

Invista will pay a $1.7 million civil penalty and spend up to an estimated $500 million to correct self-reported environmental violations discovered at facilities in seven states. The company disclosed more than 680 violations of water, air, hazardous waste, emergency planning and preparedness, and pesticide regulations to EPA after auditing 12 facilities it acquired from DuPont in 2004.



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Border Patrol Agent Pleads Guilty for Attempting to Receive Protected Leopard Tortoises

Rene Soliz of Alice, Texas, pleaded guilty today in U.S. District Court in Corpus Christi, Texas, to a violation of the Lacey Act for attempting to receive fifteen Tanzanian leopard tortoises that were transported into the United States in violation of a law, regulation or treaty, specifically, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).



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Five Charged in $70 Million “Dream Home” Mortgage Fraud Scheme

A federal grand jury has indicted four defendants, and an information has been filed against a fifth defendant, for their participation in a massive mortgage fraud scheme that allegedly promised to pay off homeowners’ mortgages on their “Dream Homes,” but left them to fend for themselves. The indictment was returned on April 22, 2009, and unsealed today.



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Texas Man Pleads Guilty to Travel with Intent to Engage in Sexual Conduct with a Minor, Possession of Child Pornography

Patrick Cochran, 47, of Lake Jackson, Texas, pleaded guilty today to one count of travel with intent to engage in illicit sexual conduct with a minor, and one count of possession of child pornography.



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Former Bank of China Managers and Their Wives Sentenced for Stealing More Than $485 Million, Laundering Money Through Las Vegas Casinos

Two former managers of the Bank of China and their wives were sentenced today after their convictions on Aug. 29, 2008, by a federal jury in Las Vegas on charges of racketeering, money laundering, international transportation of stolen property as well as passport and visa fraud.



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Defense Department Official Charged with Espionage Conspiracy

A Defense Department official has been charged with conspiracy to communicate classified information to an agent of a foreign government.



  • OPA Press Releases

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Former Image Entry Inc., VP Pleads Guilty to Securities and Wire Fraud Conspiracy, and Tax Evasion

Michael Wayne Sulfridge, a resident of Union Grove, Ala., and former vice president of corporate finance at Image Entry, Inc. (Image Entry), pleaded guilty today to fraud and tax evasion charges stemming from the company’s 2001 acquisition by Sourcecorp, Inc. (Sourcecorp).



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Former State Department Official and Wife Arrested for Serving as Illegal Agents of Cuba for Nearly 30 Years

A former State Department official and his wife have been arrested on charges of serving as illegal agents of the Cuban government for nearly 30 years and conspiring to provide classified U.S. information to the Cuban government.



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United States Files False Claims Act Suit Against California Mortgage Lender Capmark Finance

The Department filed suit against California mortgage lender Capmark Finance Inc., charging that Capmark violated the False Claims Act by making false statements on applications for federal mortgage insurance covering residential nursing homes.



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Defense Department Official Indicted on Espionage, False Statement Charges

A federal grand jury in the Eastern District of Virginia has indicted James Wilbur Fondren Jr., on one count of conspiracy to communicate classified information to an agent of a foreign government and act as an illegal foreign agent; four counts of unlawfully communicating classified information to an agent of a foreign government; and three counts of making false statements to the FBI.



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Owner of New Jersey Landscaping Sub-Contractor Pleads Guilty to Defrauding the Environmental Protection Agency

The co-owner of a Martinsville, N.J., landscaping company pleaded guilty to participating in a fraud conspiracy at the Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J. Frederick Landgraber pleaded guilty in the U.S. District Court of New Jersey today to one count of conspiracy to defraud the EPA from approximately March 2002 until approximately June 2005 at the Federal Creosote site.



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Eight Miami-Area Residents Charged in $22 Million Medicare Fraud Scheme Involving Home Health Care Agencies

Eight Miami-Dade County, Fla., residents have been indicted in connection with an alleged $22 million Medicare fraud scheme operated out of Miami businesses purporting to specialize in home health care services. A temporary restraining order freezing assets of the indicted defendants and their companies was also filed.



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Fort Myers Real Estate Agents Sentenced to Prison for Tax Crimes

Sheri Redekker Barry and Warren Thomas Barry, a wife and husband who are both real estate agents in Fort Myers, Fla., have been sentenced to prison for conspiracy and failure to file tax returns. U.S. District Court Judge John E. Steele on Monday sentenced Sheri Barry to 36 months in prison and Warren Barry to 24 months in prison. The court also ordered the Barrys to pay restitution in the amount of $555,728.



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United States Settles False Claims Act Allegations Against National Home Builder and Mortgage Lender

Beazer Homes USA Inc. has agreed to pay the United States $5 million dollars, plus contingent payments of up to $48 million dollars to be shared with victimized private homeowners, to resolve allegations that it, and Beazer Mortgage Corp., were involved in fraudulent mortgage origination activities in connection with federally insured mortgages.



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Canadian Executive Pleads Guilty to Fraud and Money Laundering Conspiracies Involving a New Jersey Environmental Protection Agency Superfund Site

A former executive of Bennett Environmental Inc. (BEI), a Canadian-based company that treats and disposes of contaminated soil, pleaded guilty to participating in a conspiracy to pay kickbacks and commit fraud at the U.S. Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J. The former executive also pleaded guilty to participating in a money laundering conspiracy and impeding a proceeding before the U.S. Securities and Exchange Commission.



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Former Boeing Engineer Convicted of Economic Espionage in Theft of Space Shuttle Secrets for China

A former Rockwell and Boeing engineer from Orange County, Calif., was remanded into custody this morning after a federal judge convicted him of charges of economic espionage and acting as an agent of the People’s Republic of China, for whom he stole restricted technology and Boeing trade secrets, including information related to the Space Shuttle program and Delta IV rocket.



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Attorney General Eric Holder at the National Black Prosecutors Association’s Profiles in Courage Luncheon

"As a prosecutor, you need to be determined enough to pursue every single violent criminal, no matter how cold the evidence. You need to be dogged enough to charge all meritorious cases, no matter how difficult the challenges. You need to be tough enough to withstand public scrutiny, no matter how unfair the criticism."




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Justice Department Signs Agreement with the Village of Midlothian, Illinois, to Improve Civic Access for People with Disabilities

The Department announced an agreement with the village of Midlothian, Ill., to improve access to civic life for persons with disabilities. The agreement was reached under the Department’s Project Civic Access initiative, which aims to bring state and local governments into full compliance with the Americans with Disabilities Act (ADA). This agreement is the 162nd under Project Civic Access.



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Five Companies Agree to $21 Million Settlement for Environmental Damages in Pennsylvania

Five companies have agreed to compensate the United States and the Commonwealth of Pennsylvania nearly $21.4 million in cash and valuable property to address natural resource damages resulting from decades of zinc smelting operations at the Palmerton Zinc Pile Superfund site in northeast Pennsylvania.



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U.S. Sues First Choice Armor & Equipment for Providing Defective Bullet-Proof Vests to Law Enforcement Agencies

The United States has filed a False Claims Act lawsuit against First Choice Armor & Equipment Inc. and its founder, Edward Dovner, for submitting false claims for bullet-proof vests purchased by the United States for federal, state, local and tribal law enforcement agencies.



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Former Border Patrol Agent Sentenced for Attempting to Receive Protected Leopard Tortoises

Rene Soliz of Alice, Texas, was sentenced today in U.S. District Court in Corpus Christi, Texas, to serve three years of supervised probation, 250 hours of community service and pay a $1,500 fine for violating the Lacey Act by attempting to receive 15 Tanzanian leopard tortoises that were transported into the United States.



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Consortium of 49 Massachusetts Law Enforcement Agencies to Pay U.S. $200,000 for Alleged False Claims

The North Eastern Massachusetts Law Enforcement Council (NEMLEC) will pay the United States $200,000 to settle allegations that it made false claims related to the use of Justice Department grant funds. Based in Boston, NEMLEC is a non-profit corporation and a law enforcement council. It is comprised of a consortium of 47 police departments in Middlesex and Essex Counties, as well as two county sheriff’s departments.



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Tennessee Demolition and Salvage Companies Indicted for Clean Air Act Violations and Defrauding the United States

Two demolition and salvage companies and three of their respective owners and supervisors were indicted today by a federal grand jury in Chattanooga, Tenn. The indictment describes a year-long scheme in which the former Standard Coosa Thatcher plant in Chattanooga was illegally demolished while still containing large amounts of asbestos.



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Madhatta Haipe Extradited to U.S. for 1995 Hostage Taking Involving U.S. and Philippine Citizens

Madhatta Haipe, a citizen of the Philippines, has been extradited from the Philippines to face trial in the District of Columbia for various crimes relating to the hostage taking of U.S. and Philippine citizens in 1995.



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Detroit Clinic Manager Pleads Guilty in Medicare Fraud Scheme

Denver resident Lil Vargas-Arias pleaded guilty today in U.S. District Court in Detroit to participating in a conspiracy to defraud the Medicare program.



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Three Individuals Indicted for Roles in Conspiracy Schemes Involving Two U.S. Environmental Protection Agency Superfund Sites in New Jersey

A Newark grand jury indicted three individuals for their participation in fraud and kickback conspiracies related to contracts at a U.S. Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J.



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Manager of Bogus Foreign Currency Exchange Ponzi Scheme Pleads Guilty to Obstruction of Justice

Teresa Vogt, a resident of Anaheim, Calif., pleaded guilty on Sept. 15, 2009, to one count of obstruction of justice before U.S. District Court Judge Dale S. Fischer in Los Angeles. Vogt and eight co-defendants were indicted in May 2005 on tax fraud, conspiracy, money laundering and other charges related to the operation of the Genesis Fund.



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Texas Man Sentenced to 76 Months in Prison for Travel with Intent to Engage in Sex with Minors

Patrick Cochran, 47, of Lake Jackson, Texas, was sentenced late on Monday in Phoenix to 76 months in prison for travel with intent to engage in sex with minors and possession of child pornography.



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Five Individuals Charged in Scheme to Defraud U.S. Government Agency Related to $9.4 Million Loan

Donald Daniels, Martin William Washburn, Irina Rebegeneau and Tapani Koivunen have been charged in conjunction with a scheme to defraud the Overseas Private Investment Corporation (OPIC), a government lending agency.



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Detroit Clinic Owner and Manager Plead Guilty to Medicare Fraud Charges

Clinic owners and operators Jose Martinez and Denisse Martinez pleaded guilty today in U.S. District Court in Detroit to participating in a conspiracy to defraud the Medicare program.



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Owner of Tennesse Salvage and Demolition Company Pleads Guilty to Environmental Crimes

Gary Fillers pleaded guilty to one criminal felony count for conspiring to violate the Clean Air Act’s “work practice standards” related to the proper stripping, bagging, removal and disposal of asbestos.



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Detroit Clinic Owner, Doctor and Office Manager Indicted in Medicare Infusion Fraud Scheme

Three Miami-Dade County, Fla., residents have been indicted in connection with an alleged $2.3 million Medicare fraud scheme operated out of X-Press Center, a Detroit-area clinic that purported to specialize in providing injection and infusion therapies.



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Minneapolis Packaged-Ice Company Agrees to Plead Guilty to Customer Allocation Conspiracy

Arctic Glacier International Inc., headquartered in St. Paul, Minn., has agreed to plead guilty and to pay a $9 million criminal fine for allocating customers. Three of the company’s former executives pleaded guilty for their roles in the conspiracy.



  • OPA Press Releases