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FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.




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Lonza and Moderna enter agreement to mass produce coronavirus vaccine

Lonza Group AG and Moderna Inc have entered a deal to develop 1 billion doses of coronavirus vaccines a year.




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AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.




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FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.




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Imperial College London to lead major coronavirus home testing programme

Aims to track the progress of the infection across the UK




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Roche’s COVID-19 antibody test approved for emergency use in the US

Ramps up capacity for testing across the country




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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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CBD Product - Patriot Hemp Company

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:

CBD Product – Patriot Hemp Company: 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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Protection Blend

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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Oxford COVID-19 vaccine programme opens for clinical trial recruitment

University of Oxford researchers working in an unprecedented vaccine development effort to prevent COVID-19 have started screening healthy volunteers (aged 18-55) for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region. The vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein is already in production but won’t be ready for some weeks still.




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India remains on USTR list of IP problem countries

India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of…



  • Focus On/Generics/India/Intellectual property law/Legal/Patents & Trademarks/USA

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European progress in long path for Lokelma

The European medicines regulator has OK’d a label update for AstraZeneca’s Lokelma (sodium zirconium…



  • AstraZeneca/Biotechnology/Cardio-vascular/Drug Trial/Europe/European Medicines Agency/Focus On/Lokelma/Regulation/Research/UK

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EU brings production home amid supply chain worries

Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,…



  • Europe/Evonik/Generics/Germany/Production

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BRIEF—US court upholds Amgen Kyprolis patent

The US District Court in Delaware issued a decision upholding the validity of patent claims from three…



  • Amgen/Biotechnology/Cipla/Focus On/Kyprolis/Legal/Oncology/Patents & Trademarks/USA

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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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FDA approval for Farxiga in new indication in heart failure patients

Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and…



  • AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA

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First targeted therapy for aggressive form of lung cancer approved by FDA

Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta…



  • Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA

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Japan grants ‘exceptional’ approval for remdesivir in COVID-19

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…



  • Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury

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With the world waiting, Roche socks $459M into COVID-19 antibody test production

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. 




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AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go

AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. 




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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.



  • OPA Press Releases

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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.



  • OPA Press Releases

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U.S. Court Rejects Two Prominent L.A. Real Estate Investors’ Attempt to Use Tax Avoidance Scheme

A federal court in Los Angeles invalidated an abusive tax shelter scheme engaged in by prominent real estate investors James Thomas and Edward Fox. U.S. District Judge John F. Walter also imposed the maximum penalty - forty percent - allowed by the tax code against them.



  • OPA Press Releases

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Five Defendants Convicted of International Sex Trafficking for Forcing Central American Girls and Women into Prostitution

Five defendants, all members or associates of an extended family, face potential life sentences after being found guilty of sex trafficking for participating in a scheme that lured young Central American women and girls into the Los Angeles area and forced them into prostitution. The defendants, four Guatemalan nationals and one Mexican citizen, were convicted on Feb. 11, 2009, of conspiracy; sex trafficking by force, fraud or coercion; and importation of aliens for purposes of prostitution.



  • OPA Press Releases

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AT&T Technical Services Corp. to Pay U.S. more than $8.2 Million to Settle False Claims Involving the E-Rate Program

AT&T Technical Services Corp. (AT&T-TSCO) has agreed to pay $8,266,414.33 as part of a civil settlement relating to allegations that the company violated the False Claims Act in connection with the Federal Communication Commission's E-Rate program.



  • OPA Press Releases

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UBS Enters into Deferred Prosecution Agreement

UBS AG, Switzerland’s largest bank, has entered into a deferred prosecution agreement on charges of conspiring to defraud the United States by impeding the Internal Revenue Service (IRS). As part of the deferred prosecution agreement and in an unprecedented move, UBS, based on an order by the Swiss Financial Markets Supervisory Authority (FINMA), has agreed to immediately provide the United States government with the identities of, and account information for, certain United States customers of UBS’s cross-border business.



  • OPA Press Releases

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BP Products to Pay Nearly $180 Million to Settle Clean Air Violations at Texas City Refinery

BP Products North America Inc. has agreed to spend more than $161 million on pollution controls, enhanced maintenance and monitoring, and improved internal management practices to resolve Clean Air Act violations at its Texas City, Texas, refinery.



  • OPA Press Releases

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Kentucky Man Pleads Guilty to Producing Child Pornography and Is Sentenced to 20 Years

Jack A. Taylor, 68, a resident of Rolling Springs, Ky., pleaded guilty today to producing child pornography and was sentenced to 20 years in prison. Taylor, appearing before U.S. District Court Judge David F. Hamilton in Indianapolis, was also ordered to serve a lifetime of supervised release following completion of his prison term, forfeit all items seized during the investigation that were used to commit his offense, and to pay $4,000 in restitution to his victim.



  • OPA Press Releases

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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.



  • OPA Press Releases

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United States Files Suit Against Missouri-Based Pharmaceutical to Block Manufacturing and Shipping of Unapproved Drugs

The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs. At the same time, KV agreed to the injunction in a consent decree.



  • OPA Press Releases

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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.



  • OPA Press Releases

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Illinois Man Convicted for Production, Receipt and Possession of Child Pornography, as Well as Bank Fraud

Carl Courtright III, of Granite City, Ill., was convicted today on child pornography and bank fraud charges in the Southern District of Illinois following a five-day jury trial. The federal jury convicted Courtright of one count of production of child pornography, two counts of possession of child pornography, one count of receipt of child pornography, as well as one count of bank fraud.



  • OPA Press Releases

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U.S. Department of Justice Promotes International Network to Combat Intellectual Property Crime

Building upon the successes of earlier efforts, the Department today announced the opening in Bangkok of a regional conference of approximately 100 key law enforcement and industry officials from more than a dozen nations with the goal of strengthening international cooperation in fighting large-scale intellectual property crimes.



  • OPA Press Releases

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Four Arrested in Killings of Eagles and Other Protected Birds

Four men have been arrested by special agents of the U.S. Fish and Wildlife Service as the result of an undercover investigation into the illegal killing and trade of bald and golden eagles and other protected birds. The men are charged in four complaints with alleged violations of the Bald and Golden Eagle Protection Act, the Migratory Bird Treaty Act, and the Lacey Act.



  • OPA Press Releases

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Justice Department Announces Agreement to Protect Rights of Military and Overseas Voters in New York Special Congressional Election

The Department has reached agreement with New York officials to help ensure that military service members and other U.S. citizens living overseas have the opportunity to vote in the state’s March 31, 2009, special election in the 20th Congressional District.



  • OPA Press Releases

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U.S. Sues 32 Individuals, Alleging $30 Million Tax Credit Scam Based on Sham Sales from Non-Existent Methane Production Facilities at Landfills

The United States has sued four Certified Public Accounts (CPA), 27 tax preparers and one other individual, seeking to bar them from promoting an alleged tax scam involving bogus income tax credits claimed for sham sales of methane from landfills.



  • OPA Press Releases

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Two Individuals Convicted on Charges of Conspiracy and Bribery in Connection with a U.S. Army Corps of Engineers New Orleans Levee Reconstruction Project

A former contract employee of the U.S. Army Corps of Engineers and a dirt, sand and gravel subcontractor were both convicted on charges of conspiracy and bribery in connection with a $16 million hurricane protection project for the reconstruction of the Lake Cataouatche Levee, south of New Orleans.



  • OPA Press Releases

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Federal Court Blocks Chicago Tax Preparation Firm from Claiming Improper Tax Credits

A federal court has barred a Chicago tax preparation firm, El Caminante, Inc. and its principal operator, Maria Colica, from preparing federal income tax returns claiming false tax credits. The company and Colica agreed to the injunction. The Government civil injunction complaint filed in the case alleged that Colica fraudulently claimed fuel tax credits for customers who were not entitled to them.



  • OPA Press Releases

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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.



  • OPA Press Releases

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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).



  • OPA Press Releases

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Utah Natural Gas Producers Agree to Air Emission Reductions, Conservation Practices

Six energy companies, in three settlements, have agreed to install pollution control equipment at a cost of over $6 million to comply with the Clean Air Act at their natural gas producing facilities in the Uinta Basin, near Vernal, Utah. The facilities are located on the Uintah &



  • 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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Colombian National Arraigned on Charges of Providing Material Support to the FARC

A 32-year-old Colombian citizen, Luz Mery Gutierrez Vergara, who was extradited from the Republic of Colombia on Thursday, made her initial appearance today in federal court in Washington, D.C., to face charges for allegedly participating in a conspiracy to provide material support to the Fuerzas Armadas Revolucionarias de Colombia, commonly known as the “FARC.”



  • OPA Press Releases

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Chinese Baby Furniture Company Pleads Guilty to Smuggling Internationally Protected Wood

Style Craft Furniture Co. Ltd., pleaded guilty today in U.S. District Court in Camden, N.J., to one count of smuggling cribs containing internationally protected wood known as “ramin.”



  • OPA Press Releases

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U.S. Intervenes in Suit Against Former Beef Suppliers to National School Lunch Program

The United States has intervened in a civil lawsuit against two former suppliers to the National School Lunch Program – Hallmark Meat Packing Company and Westland Meat Company Inc. – for submitting false and fraudulent claims to the Agricultural Marketing Service (AMS), a division of the U.S. Department of Agriculture (USDA). All ground beef containing defendants’ products was recalled by USDA as of Feb. 16, 2008, and defendants no longer supply beef to the National School Lunch Program or AMS.



  • OPA Press Releases

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Deputy Attorney General David Ogden's Address at the American Bar Association Section of Litigation 2009 Annual Conference John Minor Wisdom Public Service and Professionalism Awards Luncheon

"To ensure that the Department holds itself to the highest standards during discovery -- as in every stage of litigation -- in our criminal cases, and also in our civil litigation, we have taken both short-term and long-term action."




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Novo Nordisk Agrees to Pay $9 Million Fine in Connection with Payment of $1.4 Million in Kickbacks Through the United Nations Oil-for-food Program

Novo Nordisk A/S (Novo), a Danish corporation based in Bagsvaerd, Denmark, has agreed to pay a $9 million penalty for illegal kickbacks paid to the former Iraqi government.



  • OPA Press Releases

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Attorney General Eric Holder at the Semi-Annual Conference of the Office of Overseas Prosecutorial Development Assistance and Training (OPDAT) Resident Legal Advisors and Foreign Service Nationals

"Helping foreign countries improve their criminal justice systems so they can cooperate more effectively with us and with their neighbors in real time is an important aspect of this department’s mission."




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Antitrust Division Announces Initiative to Help Protect Recovery Funds from Fraud, Waste and Abuse

The Department's Antitrust Division announced the details of its newly formed initiative aimed at preparing government officials and contractors to recognize and report efforts by parties to unlawfully profit from the stimulus projects that are being awarded as part of The American Recovery and Reinvestment Act of 2009.    



  • OPA Press Releases