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NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population

NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent.




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Regeneron says antibody for COVID-19 could be ready this year

Two antibody cocktails for COVID-19 could be available as early as this autumn




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COVID-19 Core Formula

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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Antibodies from llamas could help in fight against COVID-19

The hunt for an effective treatment for COVID-19 has led one team of researchers to find an improbable ally for their work: a llama named Winter. The team - from The University of Texas at Austin, the National Institutes of Health and Ghent University in Belgium - reports their findings about a potential avenue for a coronavirus treatment involving llamas on May 5 in the journal Cell.




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Supercomputer simulations present potential active substances against coronavirus

Several drugs approved for treating hepatitis C viral infection were identified as potential candidates against COVID-19, a new disease caused by the SARS-CoV-2 coronavirus. This is the result of research based on extensive calculations using the MOGON II supercomputer at Johannes Gutenberg University Mainz (JGU). One of the most powerful computers in the world,




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Mallinckrodt’s INOmax successful in trial of neonates with pulmonary hypertension

UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive…



  • Drug Trial/Inomax/Mallinckrodt/Nitric Oxide/Pharmaceutical/Research/Respiratory and Pulmonary/UK

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Regeneron rockets as financial results provide perfect picture of growth

Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter…



  • Anti-virals/Biotechnology/Dermatologicals/Dupixent/Eylea/Financial/Immuno-oncology/Inflammatory diseases/Libtayo/Management/Oncology/Ophthalmics/Regeneron/REGN-COV2/USA

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Akebia soars on positive Ph III trial results for vadadustat

Shares of US biotech Akebia Therapeutics were up more than 35% at $11.72 by early afternoon today, after…



  • Akebia Therapeutics/Biotechnology/Drug Trial/Nephrology and Hepatology/Research/USA/vadadustat

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Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 




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Bristol Myers Squibb's blood thinner Eliquis soars on COVID-19 demand, but Opdivo could suffer: execs

Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year.




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China approves Novartis' multiple sclerosis treatment Mayzent

Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday.




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Canadian Company to Pay U.S. More Than $1 Million Related to Sale of Defective Bullet-proof Vests

Barrday Inc. and two related companies have agreed to pay the United States more than $1 million to resolve allegations that they violated the False Claims Act in connection with their role in the weaving of Zylon fabric used in the manufacture and sale of defective Zylon bullet-proof vests. Barrday, headquartered in Cambridge, Ontario, Canada, is a weaver of ballistic fabrics and designs and produces specialty industrial textiles.



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Former Oak Ridge Complex Employee Pleads Guilty to Unlawful Disclosure of Restricted Atomic Energy Data

Roy Lynn Oakley, 67, a resident of Harriman, Tenn., pleaded guilty today in U.S. District Court in Knoxville, to count one of an indictment charging him with unlawful disclosure of Restricted Data under the Atomic Energy Act, in violation of 42 U.S.C., Section 2274(b).



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Former AIG Vice President Sentenced to Four Years in Prison for Role in Fraudulent Manipulation Scheme

The former vice president of reinsurance of American International Group Inc. (AIG), was sentenced today to four years in prison for his role in a fraudulent scheme to manipulate AIG’s financial statements.



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Final Defendant Pleads Guilty to Anti-Obama Assaults

Ralph Nicoletti pleaded guilty in Brooklyn, N.Y., federal court today before U.S. District Judge Carol B. Amon to committing three assaults targeting African-American residents in Staten Island, N.Y., on the night of President Barack Obama’s election victory. Nicoletti was the last of four defendants to plead guilty in the federal prosecution stemming from the attacks.



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Former Tulsa Businessman Sentenced to 11 Years in Prison for Receiving Child Pornography

Terry Brian Dobbs, an Oklahoma businessman, was sentenced today to 11 years in prison for receiving images of child pornography. Dobbs, 51, was also sentenced to lifetime supervised release following his term in prison by U.S. District Judge Gregory Frizzel, and was ordered to pay an $8,000 fine.



  • OPA Press Releases

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Five Individuals Indicted for Devising and Participating in Stock Manipulation Scheme

A 24-count indictment charging five individuals with various crimes arising from an alleged scheme to defraud investors through the manipulation of the publicly traded stocks of three companies was unsealed today in Tulsa, Okla.



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Four Individuals Indicted for Racially-Motivated Assault in Nampa, Idaho

Four individuals have been arrested and charged with carrying out a racially-motivated beating and conspiring to interfere with the civil rights of an African-American man in Nampa, Idaho.



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Fraudulent Tax Return Preparer Sentenced to Prison

DaJuan Jackson, a former tax return preparer in District Heights, Md., was sentenced to 51 months in prison by U.S. District Judge Roger W. Titus for preparing false tax returns for customers.



  • OPA Press Releases

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Fraudulent Tax Return Preparer Sentenced to Prison

Rodrick Williams, a former tax return preparer from District Heights, Md., was sentenced to 24 months in prison by U.S. District Judge Roger W. Titus for preparing false tax returns for customers.



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Justice Department Sues Large Multi-Family Housing Developer Alleging Disability-Based Housing Discrimination

The Department filed a lawsuit today against JPI Construction L.P. (JPI) and six JPI-affiliated companies in U.S. District Court in Dallas for failing to provide accessible features required by the Fair Housing Act and the Americans with Disabilities Act at multi-family housing developments in Texas and other states.



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U.S. Asks Courts in California & South Carolina to Shut Down Promoters of Allegedly Fraudulent $39.2 Million Tax Refund Scam

The United States has sued tax return preparers in Placerville, Calif., and Columbia, S.C., seeking to bar them from preparing federal tax returns for others. According to the government complaints in the two cases, Teresa Marty of Pollock Pines, Calif., and Winston Able of Blythewood, S.C., prepare federal income tax returns for their customers that claim fraudulent tax refunds.



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Fairfield, Calif., Couple Indicted on Federal Civil Rights Charge for Alleged Bias-Motivated Assault

A Fairfield, Calif., couple was indicted today by a federal grand jury in Sacramento, Calif., on federal civil rights charges related to an alleged bias-motivated assault on an Indian-American couple. The two-count indictment alleges that on the evening of July 14, 2007, Joseph and Georgia Silva committed a bias-motivated assault on another couple at a public beach in South Lake Tahoe, Calif.



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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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Attorney Indicted for Conspiracy and Wire Fraud in Stock Registration and Manipulation Scheme

A securities attorney was charged in an indictment unsealed today with participating in a stock registration evasion scheme involving nine different publicly traded companies and with defrauding investors in a manipulation scheme related to three of the companies.



  • OPA Press Releases

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South Florida Stock Trader Pleads Guilty to Market Manipulation Scheme

A stock trader from Jupiter, Fla., pleaded guilty today to engaging in a market manipulation scheme involving several publicly traded companies. Earlier today, Paul M. Gozzo, 33, pleaded guilty before U.S. District Judge Donald L. Graham in Miami to one count of conspiracy to commit securities fraud and one count of securities fraud.



  • OPA Press Releases

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Puerto Rico Political Consultant Sentenced to Three Months in Prison and Three Months of Home Detention

Alberto Goachet, 67, a political consultant and aide to former Puerto Rico Sen. Jorge De Castro Font, was sentenced today to three months in prison, three months of home detention and three years of supervised release. Goachet pleaded guilty on Dec. 4, 2008, to a one-count information charging him with conspiring with De Castro Font and others to launder money provided by a Puerto Rico businessman to De Castro Font.



  • OPA Press Releases

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Connecticut Resident Pleads Guilty to Multi-Million Dollar Tax Fraud Conspiracy

A Newton, Conn., resident who was involved in operating three businesses in Brooklyn, N.Y., pleaded guilty to conspiring to defraud the Internal Revenue Service (IRS). Mariusz Debowksi pleaded guilty in U.S. District Court in Manhattan to conspiracy to aid another in filing false tax returns.



  • OPA Press Releases

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Connecticut Resident Pleads Guilty to Multi-Million Dollar Tax Fraud Conspiracy Involving New York City Hospital

A Trumbull, Conn., resident who was involved in operating three businesses in Brooklyn, N.Y., pleaded guilty to conspiring to defraud the Internal Revenue Service (IRS). Krzysztof Koczon pleaded guilty in U.S. District Court in Manhattan to conspiracy to aid another in filing false tax returns.



  • OPA Press Releases

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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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Senior Executives of Auto Parts Retailer Charged with Scheme to Manipulate Corporate Earnings

Two former senior executives of CSK Auto Corp. (CSK), have been charged in a 31-count indictment for a scheme to manipulate the company’s reported earnings. The indictment, returned on April 7, 2009, by a federal grand jury in Phoenix, charges Martin G. Fraser, 53, of Glendale, Ariz., and Don W. Watson, 53, of Gilbert, Ariz., with conspiracy, securities fraud, mail fraud, false filings with the U.S. Securities and Exchange Commission (SEC), false books and records, and false statements to its auditor.



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Justice Department Highlights FY 2008 Tax Enforcement Results

The Tax Division announced highlights of its work during the past year to defend and enforce the nation’s tax laws. The Tax Division has assisted the Internal Revenue Service (IRS) in tracking down tax cheats who use offshore accounts, combating abusive tax shelters, stopping tax defiers and shutting down tax schemes and scams. During FY 2008, the Tax Division also successfully defended refund suits against the United States representing claims of nearly $803 million, and collected, through affirmative litigation, over $178 million.



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Justice Department Resolves Lawsuit Alleging Disability-Based Housing Discrimination at 12 Multifamily Housing Complexes in Louisville, Kentucky

The Department announced that a federal district court judge in Louisville, Ky., approved a settlement of the Department’s lawsuit alleging that those involved in the design and construction of 12 multifamily housing complexes discriminated on the basis of disability. The complexes contain more than 800 units covered by the Fair Housing Act’s accessibility provisions.



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Maryland Man Pleads Guilty to Using a Noose to Assault a Man at the Pentagon

William Michael King, a fifty-year-old truck driver from Maryland, pleaded guilty today to assault and violating the civil rights of an African American man he encountered while King delivered construction materials to the Pentagon.



  • OPA Press Releases

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Promoter of Fraudulent Tax Defiance Scheme Pleads Guilty to Mail Fraud

Jerry R. Williamson, a promoter of the American Rights Litigators/Guiding Light of God Ministries (ARL) formerly based in Florida, pleaded guilty today to mail fraud. Williamson appeared today before Judge Henry H. Kennedy Jr. in Washington, D.C., and admitted that he that he sent a fictitious “Bill of Exchange” purporting to be drawn upon the U.S. Treasury to the Bureau of Land Management of the Department of the Interior.



  • OPA Press Releases

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Two South Florida Men Indicted in Connection with Fraudulent ATM Business Opportunity Venture

A Miami federal grand jury has charged two South Florida men with conspiracy, mail and wire fraud in connection with the operation of a fraudulent ATM business opportunity. The criminal charges are part of the government’s continued nationwide crackdown on business opportunity fraud.



  • OPA Press Releases

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Justice Department Reaches Settlement with Consolidated Multiple Listing Service Inc.

The Department has reached a proposed settlement with Consolidated Multiple Listing Service Inc. (CMLS) that requires CMLS to change its rules to allow low-priced and innovative brokers to compete with traditional brokers in the Columbia, S.C., area. The Department said the rules caused consumers to pay more for residential real estate brokerage services in the Columbia area.



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Three Ohio Residents Plead Guilty to Conspiracy to Commit Bank Fraud for Fraudulent Real Estate Loan Scheme

Todd Gongwer of Dublin, Ohio; Lance Parker of Dublin, Ohio; and Joel Lee, of Galena, Ohio, pleaded guilty today to conspiracy to commit bank fraud. Gongwer, a licensed real estate agent, also pleaded guilty to tax evasion in the hearing before Judge Michael H. Watson in Columbus, Ohio. Parker also pleaded guilty to illegally structuring cash transactions.



  • OPA Press Releases

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Justice Department Resolves Lawsuit Alleging Disability-Based Housing Discrimination at Four Multifamily Housing Complexes in Spokane County, Washington

The Department announced today a settlement of a lawsuit alleging discrimination on the basis of disability in the design and construction of four multifamily housing complexes in the Spokane, Wash., area in violation of the federal Fair Housing Act.



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United States Sues California Man to Bar Him from Promoting Fraudulent Tax Schemes

The Department has filed suit against convicted tax fraud promoter Daniel Andersen to enjoin him from promoting fraudulent tax schemes. The government’s complaint alleges that Andersen directed the activities of both the Institute for Global Prosperity (between 1996 and 2002) and the Stratia Corporation (between 2002 and 2004). The lawsuit states that Andersen used these organizations to promote the fraudulent tax schemes sold by others in a series of audio recordings and at offshore conferences.



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Defense Contractor Pleads Guilty to Wire Fraud in Connection with the Procurement of a Bullet-Proof Vest Contract in Iraq

A defense contractor has pleaded guilty to wire fraud and has admitted to engaging in other bribery-related conduct in connection with contracts in Iraq. According to the plea agreement filed in the U.S. District Court in the District of Columbia on Dec. 18, 2007, and unsealed today, Diana Bakir Demilta, a U.S. citizen, pleaded guilty to one count of wire fraud.



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Appeals Court Affirms Government’s Default Termination of Navy Contract for A-12 Stealth Attack Aircraft

The U.S. Court of Appeals for the Federal Circuit has affirmed a judgment upholding the Navy’s termination for default of a contract with McDonnell Douglas and General Dynamics for the A-12 stealth attack aircraft.



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Fraudulent Telemarketers Who Claimed U.S. Victims Won Large Sweepstakes Sentenced to Prison for Roles in Scheme

The owner of a Costa Rica-based telemarketing call center and two employees of another Costa Rica call center were sentenced for their roles in schemes that targeted and defrauded thousands of American victims of more than $10 million.



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Attorney General Vacates Compean Order, Initiates New Rulemaking to Govern Immigration Removal Proceedings

Attorney General Eric Holder today vacated the order issued in Matter of Compean by Attorney General Mukasey in January and announced his intention to initiate a new rulemaking proceeding for regulations to govern claims of ineffective assistance of counsel in removal proceedings.



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Obama Administration Announces National Strategy to Reduce Drug Trafficking and Flow of Bulk Cash and Weapons Across Southwest Border

Today, U.S. Attorney General Eric Holder, U.S. Department of Homeland Secretary Janet Napolitano, and Director of National Drug Control Policy Gil Kerlikowske released President Obama’s strategy to stem the flow of illegal drugs and their illicit proceeds across the Southwest border and reduce associated crime and violence in the region.



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Jenkens & Gilchrist Attorneys, BDO Seidman Accountants, and Bankers Charged in Criminal Tax Fraud Related to Tax Shelters Generating Over Seven Billion Dollars of Fraudulent Tax Losses

An indictment was filed today charging seven individuals -- three former shareholders of the Jenkens & Gilchrist law firm (J&G), the former Chief Executive Officer and a former tax partner from the BDO Seidman accounting firm (BDO), and two former bankers from a foreign bank with headquarters in New York (Bank A) -- with tax fraud conspiracy and related crimes arising out of tax shelters promoted by J&G, BDO, and the bank.



  • OPA Press Releases

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Georgia Federal Court Permanently Bars Fulton County Man from Preparing Tax Returns

A federal court in Atlanta has permanently barred Derrick Jackson and his businesses from preparing federal tax returns for others. The court said that since 2002, Jackson "has prepared blatantly fraudulent tax returns for customers." Jackson’s businesses were called Tax Wisdom and International Tax and Accounting Services.



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Honolulu Man and Woman Indicted on Federal Sex Trafficking Charges

A federal grand jury in the District of Hawaii has indicted Rodney D. King, 43, and Sharon-Mae Nishimura, 30, both of Honolulu, on multiple counts of federal sex trafficking of adult women and minor female victims.



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Justice Department Files Lawsuit Alleging Racial Discrimination at Mobile Home Park in Gulfport, Mississippi

The Department today filed a lawsuit against the former owner and managers of Homestead Mobile Home Village, a mobile home park in Gulfport, Miss., for violating the Fair Housing Act by discriminating against black tenants on the basis of race or color.



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Detroit Spammer and Four Co-Conspirators Plead Guilty to Multi-Million Dollar E-mail Stock Fraud Scheme

Five individuals pleaded guilty today in federal court in Detroit for their roles in a wide-ranging international stock fraud scheme involving the illegal use of bulk commercial e-mails, or "spamming."



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