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Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.




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Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch

Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light.




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Teva generics benefit from COVID-19 bump––but the boom may not last

With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year.




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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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GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed

Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said.




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FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.




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Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 




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Gilead hit with Iranian cyberattack for role in COVID-19 response: report

Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.




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FDA commissioner in self-quarantine after exposure to person with COVID-19

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.




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Indonesia reports 533 new COVID-19 cases, biggest in a day

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.




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New York governor says 5-year old died from rare COVID-related complications

A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday.




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Factbox: Latest on the worldwide spread of the coronavirus

More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday.




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FDA grants emergency use authorization to Quidel for first antigen test for COVID-19

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.




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Journal Watch (Holiday 2019)

Closing out another year at BiotechDueDIligence, thank you for following along! Enjoy another round-up of scientific and medical journal articles driving the conversation and newsflow in biotech.There's lots of great #immunology in @sciencemagazine this week! @JSRustenhoven & @jonykipnis (@kipnislab @UVA) author a fascinating Perspective on how immune cells bypass the blood–brain barrier!https://t.co/6QjcNxU0p6 pic.twitter.com/njjnrn9Yej— Seth Thomas Scanlon (@ImmunoEditor) December 20, [...]




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Former Florida State Corrections Officer Convicted of Federal Civil Rights Crime

A federal jury in Jacksonville, Fla., found Paul Tillis, a former Florida Department of Corrections officer, guilty on Jan. 16, 2009, of a felony federal civil rights violation for an August 2005 assault on an inmate.



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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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Third Individual Pleads Guilty to Illegally Accessing Confidential Passport Files

A third individual pleaded guilty today to illegally accessing numerous confidential passport application files. Gerald R. Lueders, 65, of Woodbridge, Va., pleaded guilty before U.S. Magistrate Judge Alan Kay in U.S. District Court for the District of Columbia to a one-count criminal information charging him with unauthorized computer access.



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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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Federal Court Bars Maine Resident from Preparing Tax Returns for Others

A federal court in Maine has permanently barred Robert A. Grover from preparing federal tax returns for others. The court also ordered the Maine resident to provide his customer lists to the government and to mail copies of the complaint and court order to his customers. Grover consented to the civil injunction order.



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Two Individuals Arrested on Federal Sex Trafficking Charges

Two men have been arrested and charged in an indictment unsealed today with crimes related to sex trafficking. Tommy Handy and his nephew, Everett Cooney, were indicted by a federal grand jury in Little Rock, Ark., for conspiracy to commit sex trafficking and sex trafficking for their roles in using force, fraud and coercion to cause juvenile girls and adult women to engage in commercial sex acts.



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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.



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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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Federal Court Bars Tennessee Resident from Preparing Tax Returns for Others

A federal district court in Tennessee has permanently barred Chattanooga resident Demita Brown-Watkins from preparing federal income tax returns for others. Brown-Watkins agreed to the civil injunction order. According to the government complaint, Brown-Watkins ran her tax-preparation business through two companies—Fastax and Rapid Tax Service—and advertised the “largest refund in town.”



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Justice Department Settles Lawsuit Alleging Military Discrimination Against the North Carolina Administrative Office of the Courts and Senior Resident Court Judge

The Department announced today that it has reached a settlement that, if approved by the court, will resolve a lawsuit filed by the Department against the Administrative Office of the Courts of the State of North Carolina and the Honorable Jerry Braswell, Senior Resident Superior Court Judge for North Carolina Judicial District 8-B, in his official capacity.



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United States Sues to Stop Florida Tax Return Preparer from Claiming Allegedly Bogus Tax Credits

The United States has sued Robert Cusenza, a West Palm Beach tax return preparer, seeking to bar him permanently from the tax preparation business. The government’s complaint asks the court to order Cusenza to stop preparing returns and to turn over his customer list to the Justice Department.



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United States Sues to Shut Down Florida Tax Return Preparer

The United States has filed suit against a Jacksonville, Fla., tax return preparer, seeking to shut down her business. According to the government complaint, Shirley Clark, who operates the Nichet Corp., has prepared at least 1,250 federal tax returns for her customers from 2004 until 2007 and, on those returns, Clark has claimed nearly $750,000 in fraudulent fuel tax credits.



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Federal Court Permanently Bars Florida “Tax Doctor” from Preparing Tax Returns

A federal court has permanently barred Harold Mette of Bradenton, Fla., from preparing federal income tax returns for others. Mette, who has a Ph.D. degree and calls his business “The Tax Doctor,” consented to the permanent injunction order, which was entered by U.S. District Judge Richard A. Lazzara in U.S. District Court for the Middle District of Florida.



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Individual Indicted in Connection with Costa Rica-based Business Opportunity Fraud Ventures

A British citizen was charged in connection with the operation of a series of fraudulent business opportunities on March 10, 2009, by a Miami federal grand jury. Sirtaj Mathauda was indicted on charges that he and his co-conspirators purported to sell vending machine, beverage and greeting card business opportunities, including assistance in establishing, maintaining and operating such businesses. The charges form part of the government’s continued nationwide crackdown on business opportunity fraud.



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Justice Department Seeks to Shut Down Florida Tax Preparer

The United States has sued a Fort Richey, Fla., tax preparer, Frank Lighty, and his tax-preparation firm – Lighty & seeking to bar them permanently from the tax preparation business. The civil injunction suit was filed in Tampa with the U.S. District Court for the Middle District of Florida.



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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.



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Former State Department Employee Sentenced for Illegally Accessing Confidential Passport Files

A former State Department employee was sentenced today to 12 months of probation and ordered to perform 100 hours of community service for illegally accessing more than 150 confidential passport application files. Dwayne F. Cross, 41, of Upper Marlboro, Md., was sentenced by U.S. Magistrate Judge John M. Facciola in Washington, D.C.



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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.



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Wyoming Highway Patrol Trooper Arrested for Violating Civil Rights by Kidnapping

Agents with the FBI, Immigration and Customs Enforcement and the Wyoming Department of Criminal Justice arrested Wyoming Highway Patrol Trooper Franklin Joseph Ryle late yesterday in Douglas, Wyo., on criminal civil rights charges.



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Justice Department Files Voting Rights Lawsuit Against Town of Lake Park, Florida

The Department filed a lawsuit today to challenge the at-large method of electing the Lake Park, Fla. Town Commission on the ground that it dilutes the voting strength of black citizens in violation of Section 2 of the Voting Rights Act. The lawsuit, filed in the U.S. District Court in Miami, alleges that as a result of racially polarized voting patterns in town elections, candidates preferred by black voters are usually defeated.



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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.



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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.



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Virginia Man Sentenced for Idaho Hunting Violations

Paul L. Arnold was sentenced today by Judge Ronald Bush of the U.S. District Court for the District of Idaho to pay a $2,500 fine, serve two years probation, and perform 50 hours of community service for two misdemeanor violations of the Lacey Act, a federal wildlife enforcement statute, which occurred near Soda Springs, Idaho.



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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.



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Lobbyist Sentenced for Destroying Evidence in Public Corruption Investigation

A partner in a Pennsylvania-based lobbying firm was sentenced today by U.S. District Judge Henry H. Kennedy Jr., to five months of home detention for destroying evidence in connection with a public corruption investigation, Acting Assistant Attorney General Rita M. Glavin of the Criminal Division, U.S. Attorney Jeffrey A. Taylor for the District of Columbia, Assistant Director of the FBI’s Washington Field Office Joseph Persichini Jr., and Special Agent in Charge C. André Martin of Internal Revenue Service (IRS) Criminal Investigation announced.



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Bronx Return Tax Preparer Indicted for Aiding in Preparation of False Tax Returns

Alexander Tajong, a Bronx, N.Y.-based return preparer, was charged today with twenty counts of willfully aiding and assisting in the preparation and filing of false income tax returns for 10 of his clients during the 2002 and 2003 tax years.



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UBS Client Pleads Guilty to Filing False Tax Return Hid Assets Worth $3 Million in Secret Swiss Bank Account

Robert Moran, of Lighthouse Point, Fla., pleaded guilty today to a criminal information charging him with filing a false income tax return. Moran appeared today before Judge James I. Cohn in Ft. Lauderdale and accepted responsibility for concealing more than $3 million in assets in a secret bank account at UBS in Switzerland.



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Quest Diagnostics to Pay U.S. $302 Million to Resolve Allegations That a Subsidiary Sold Misbranded Test Kits

Quest Diagnostics Incorporated and its subsidiary, Nichols Institute Diagnostics (NID), have entered into a global settlement with the United States to resolve criminal and civil claims concerning various types of diagnostic test kits that NID manufactured, marketed and sold to laboratories throughout the country until 2006. The payment of $302 million will resolve these allegations and represents one of the largest recoveries ever in a case involving a medical device.



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Subsidiaries of Swedish Company, Trelleborg AB, Agree to Plead Guilty and Pay $11 Million in Criminal Fines

Two subsidiaries of the Swedish company Trelleborg AB, one based in Virginia and the other in France, have agreed to plead guilty and pay a total of $11 million in criminal fines for their participation in separate conspiracies affecting the sales of marine products sold in the United States and elsewhere.



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Deputy Attorney General David Ogden at the Attorney General’s Law Enforcement Summit

"Community policing in the United States is built on two partnerships: first, and fundamentally, the partnership between state, local and tribal law enforcement and the communities they serve. And second, the partnership between these law enforcement agencies and the Department of Justice."




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Individual Charged with Participating in Scheme to Steal Large Quantities of Fuel from U.S. Army in Iraq

A federal grand jury returned an indictment today charging Robert Jeffery, 55, with conspiracy and theft of government property in connection with a scheme to steal large quantities of fuel from the U.S. Army in Iraq.



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Kansas Man Charged with Immigration Crimes in Connection with 1994 Genocide in Rwanda

Lazare Kabaya Kobagaya, 82, of Topeka, Kan., was arrested today on charges of naturalization fraud and misuse of an alien registration card. According to the indictment, Kobagaya allegedly participated in genocidal activities during the 1994 Rwandan conflict including mobilizing attackers to commit arson and murder. Kobagaya is alleged to have failed to disclose his alleged participation in these activities during his immigration and naturalization processes.



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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.”



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President of Long Island Defense Contractor Pleads Guilty to Customer Allocation

The owner and president of a Ronkonkoma, N.Y., designing and manufacturing company pleaded guilty to conspiring to allocate a U.S. Navy contract for Navy straps. Navy straps are a type of tiedown equipment used by the U.S. Navy to secure munitions and other supplies for transport on ships and airplanes.



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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.



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