era NICE backtracks to approve Janssen's Stelara in ulcerative colitis By www.pharmafile.com Published On :: Tue, 28 Apr 2020 10:20:00 +0000 NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year. Full Article Janssen NICE Research and Development Stelara ulcerative colitis Manufacturing and Production
era Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer By www.pharmafile.com Published On :: Wed, 29 Apr 2020 11:49:31 +0000 A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged. Full Article cancer Libtayo lung cancer Regeneron Research and Development Sanofi
era Oligonucleotide Therapeutics and Delivery Conference 2020 By www.pharmanews.eu Published On :: Wed, 22 Apr 2020 10:00:00 +0200 16 - 17 September 2020, London, UK. Oligonucleotide therapeutics - the emerging medicine class - are harnessing the therapeutic benefit of targeting genetic material via antisense, mRNA, RNAi, saRNA and siRNA. Their market growth: CAGR of 13.7% projected to reach USD 8.2 billion by 2024 is driven by their potential to provide more efficacious and less toxic alternatives to small molecules. Full Article Featured Events
era Bristol-Myers' CAR-T cell therapy meets with FDA delay By www.thepharmaletter.com Published On :: Wed, 06 May 2020 15:23:00 +0100 The submission of additional information, upon the request of the US regulator, has delayed the action… Full Article Biotechnology/Bristol-Myers Squibb/Focus On/Immuno-oncology/lisocabtagene maraleucel/Regulation/Research/US FDA/USA
era First targeted therapy for aggressive form of lung cancer approved by FDA By www.thepharmaletter.com Published On :: Thu, 07 May 2020 11:10:00 +0100 Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta… Full Article Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA
era PTC Therapeutics to acquire Censa Pharmaceutical By www.thepharmaletter.com Published On :: Thu, 07 May 2020 14:18:00 +0100 In another strategic M&A deal announced so far this month, PTC Therapeutics has entered into an agreement… Full Article Biotechnology/Censa Pharmaceuticals/Companies mergers and acquisitions/Metabolics/PTC Therapeutics/Rare diseases/sepiapterin/USA
era Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:22:41 +0000 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. Full Article
era Gilead hit with Iranian cyberattack for role in COVID-19 response: report By www.fiercepharma.com Published On :: Fri, 08 May 2020 19:43:17 +0000 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. Full Article
era Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT By www.fiercepharma.com Published On :: Fri, 08 May 2020 19:45:56 +0000 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. Full Article
era Former Florida State Corrections Officer Convicted of Federal Civil Rights Crime By www.justice.gov Published On :: Wed, 21 Jan 2009 11:01:29 EST 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. Full Article OPA Press Releases
era Chicago Police Officer Pleads Guilty to Violating Federal Civil Rights of a Man Beaten While Restrained in a Wheelchair By www.justice.gov Published On :: Thu, 22 Jan 2009 14:28:08 EST A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair. Full Article OPA Press Releases
era New York Man Pleads Guilty to Federal Hate Crime Conspiracy By www.justice.gov Published On :: Mon, 26 Jan 2009 11:47:13 EST Brian Carranza, 21, pleaded guilty today before U.S. District Court Judge Carol B. Amon in Brooklyn, N.Y., to conspiring to assault African-American residents in Staten Island, N.Y., in retaliation for President Barack Obama winning last years presidential election. Full Article OPA Press Releases
era Two Oklahoma County Corrections Officers Indicted for Federal Civil Rights Violation in Death of Oklahoma City Man By www.justice.gov Published On :: Mon, 2 Feb 2009 18:39:46 EST A federal grand jury indictment was unsealed today in Oklahoma City charging corrections officers Gavin Littlejohn, 25, of Oklahoma City, and Justin Isch, 21, of Edmond, Okla., with a federal civil rights violation for the fatal assault of Christopher Beckman at the Oklahoma County Detention Center in May 2007. Full Article OPA Press Releases
era U.S. Recovers $19 Million from AMEC Construction Management to Settle Litigation Regarding Fraud, False Claims, Kickbacks & Re-Procurement Costs on Federal Construction Contracts By www.justice.gov Published On :: Mon, 2 Feb 2009 17:18:08 EST 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 ACMIs contract to build the Thomas F. Eagleton United States Courthouse in St. Louis, Missouri. ACMI was formerly known as Morse Diesel International Inc. Full Article OPA Press Releases
era Federal Court Bars Maine Resident from Preparing Tax Returns for Others By www.justice.gov Published On :: Tue, 3 Feb 2009 16:51:43 EST 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. Full Article OPA Press Releases
era Attorney General Eric Holder Addresses Department of Justice Employees By www.justice.gov Published On :: Tue, 3 Feb 2009 09:17:54 EST The Justice Department has aptly been described as the “crown jewel” of the federal government. It has attained this distinction not because of any laws or regulations, cases or controversies, buildings or equipment, but rather because of the quality, integrity, and dedication of the people who work tirelessly to carry out the Department’s vital mission. Full Article Speech
era Federal Court Bars Connecticut Woman from Preparing Tax Returns for Others By www.justice.gov Published On :: Wed, 4 Feb 2009 13:04:57 EST A federal district court in Connecticut has permanently barred Elda Sinani, a resident of that state, from preparing federal tax returns for others. Sinani consented to the civil injunction order. Full Article OPA Press Releases
era Two Individuals Arrested on Federal Sex Trafficking Charges By www.justice.gov Published On :: Thu, 5 Feb 2009 17:34:27 EST 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. Full Article OPA Press Releases
era District of Columbia Seafood Company, Owner and Employee Plead Guilty to Federal Trafficking Charges By www.justice.gov Published On :: Thu, 12 Feb 2009 14:27:13 EST A fish wholesaler, its owner and an employee have all pleaded guilty in U.S. District Court for the District of Columbia for the illegal purchase and sale of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007. Full Article OPA Press Releases
era U.S. Asks Federal Court to Shut Down Iowa Tax Preparers By www.justice.gov Published On :: Fri, 13 Feb 2009 15:35:06 EST The United States has sued a Clive, Iowa, couple to bar them from preparing federal tax returns for others. According to the government complaint, Jill Schwartz-Musin, her husband Howard Musin, and their business, SSC Services, prepare fraudulent federal income tax returns for small business owners. Full Article OPA Press Releases
era United States Files Clean Air Lawsuit Against Louisiana Generating By www.justice.gov Published On :: Wed, 18 Feb 2009 15:14:54 EST The United States has filed a complaint against Louisiana Generating alleging that the company violated the Clean Air Act by operating the Big Cajun 2 Power Plant, a coal-fired power plant in New Roads, La., without also installing and operating modern pollution control equipment after the generating units had undergone major modifications. Full Article OPA Press Releases
era Federal Court Bars Tennessee Resident from Preparing Tax Returns for Others By www.justice.gov Published On :: Fri, 20 Feb 2009 16:42:25 EST 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 companiesFastax and Rapid Tax Serviceand advertised the largest refund in town. Full Article OPA Press Releases
era Memphis Man Pleads Guilty to Federal Sex Trafficking Charges By www.justice.gov Published On :: Mon, 23 Feb 2009 12:37:02 EST Leonard Fox a/k/a Anton a/k/a Daddy pleaded guilty today to a federal civil rights charge for sex trafficking of minors. In U.S. District Court in Memphis, Fox admitted to recruiting and obtaining underage girls and arranging for those girls to engage in commercial sex acts for his financial benefit. Full Article OPA Press Releases
era Japanese Corporate Operator of Cargo Vessel Sentenced to Pay $1.75 Million for Conspiracy and Falsifying Records By www.justice.gov Published On :: Tue, 24 Feb 2009 18:09:55 EST U. S. District Judge Steven D. Merryday today sentenced the Japanese corporation Hiong Guan Navegacion Japan Co. Ltd., that operates the commercial cargo ship M/V Balsa-62, to three years probation and $1.75 million in penalties for conspiring to falsify and falsifying environmental compliance records. Full Article OPA Press Releases
era Two Oregon Men Plead Guilty to Federal Hate Crime By www.justice.gov Published On :: Tue, 24 Feb 2009 17:22:18 EST Gary Moss and Devan Klausegger of Medford, Ore., pleaded guilty today to conspiring to interfere with civil rights. According to facts stipulated in their plea agreements and set forth in the indictment, on May 26, 2008, Moss poured a flammable liquid on the front lawn of the victims residence in the shape of a cross and the letters KKK. Full Article OPA Press Releases
era Federal Court Permanently Bars Florida Tax Doctor from Preparing Tax Returns By www.justice.gov Published On :: Wed, 25 Feb 2009 15:45:55 EST 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. Full Article OPA Press Releases
era Justice Department Settles Lawsuit Against Ecolab Inc. to Enforce Employment Rights of Michigan U.S. Army Veteran By www.justice.gov Published On :: Wed, 4 Mar 2009 17:45:33 EST The Department announced today that it has entered into a consent decree with Ecolab Inc. (Ecolab) that will resolve the Departments complaint, which was filed today, that Ecolab failed to reemploy Michigan veteran Stephen Alasin in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994, as amended (USERRA). The consent decree was approved by the court today as well. Full Article OPA Press Releases
era Fairfield, Calif., Couple Indicted on Federal Civil Rights Charge for Alleged Bias-Motivated Assault By www.justice.gov Published On :: Fri, 6 Mar 2009 10:00:15 EST 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. Full Article OPA Press Releases
era 60th Felony Conviction Obtained in Software Piracy Crackdown Operation Fastlink By www.justice.gov Published On :: Fri, 6 Mar 2009 18:27:04 EST The 60th felony conviction from Operation Fastlink, a major Department of Justice initiative to combat online piracy worldwide. Bryan Thomas Black, 30, of Waterloo, Ill., pleaded guilty today to one count of conspiracy to commit criminal infringement of a copyright for his involvement in a multinational software piracy organization that was targeted by investigators as part of Operation Fastlink, an internationally coordinated 18-month investigation. Full Article OPA Press Releases
era Federal Court Shuts Down North Carolina Tax Preparer By www.justice.gov Published On :: Wed, 11 Mar 2009 11:55:28 EDT A federal court has permanently barred Raymond A. Renfrow of Elm City, N.C., from preparing federal income tax returns for others. The U.S. District Court for the Eastern District of North Carolina entered the civil injunction order, which also stops Renfrow from promoting a tax fraud scheme that used sham trusts to falsely deduct customers non-deductible personal expenses. Full Article OPA Press Releases
era Jury Convicts Former Social Worker of Defrauding the Department of Veterans Affairs and Obstructing Justice By www.justice.gov Published On :: Fri, 13 Mar 2009 10:05:02 EDT A former Department of Veterans Affairs (VA) social work associate was convicted yesterday by a jury on four counts of honest services mail fraud, violating the criminal conflict of interest statute and making a false statement to agency officials. Full Article OPA Press Releases
era U.S. Border Patrol Agent Indicted on Federal Civil Rights Charge for Assault in Federal Detention Facility By www.justice.gov Published On :: Fri, 13 Mar 2009 13:59:17 EDT 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. Full Article OPA Press Releases
era General Maritime Management (Portugal) Fined $1 Million for Enviromental Crimes By www.justice.gov Published On :: Mon, 16 Mar 2009 12:43:01 EDT 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 worlds oceans as required by United States and international law. Full Article OPA Press Releases
era Federal Judge Shuts Down Two Dallas Tax Preparers By www.justice.gov Published On :: Mon, 23 Mar 2009 16:14:46 EDT A federal court has shut down two Dallas tax preparers during the height of tax-filing season. Chief Judge Sidney Fitzwater of the U.S. District Court for the Northern District of Texas signed a temporary restraining order barring Ethel Washington from preparing any tax returns. The court has also permanently barred Washingtons former employer, Tina Preston, and her firm, The Preston Group & Associates Inc., from preparing federal tax returns. Full Article OPA Press Releases
era Veterans Affairs Official to Plead Guilty to Conspiracy and Wire Fraud By www.justice.gov Published On :: Mon, 23 Mar 2009 17:19:39 EDT The Associate Director of the Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy in Hines, Ill., agreed to plead guilty to being part of a conspiracy to defraud the VA and the Small Business Administration (SBA). His wife and the temporary staffing company she founded agreed to plead guilty to participating in the same conspiracy. Full Article OPA Press Releases
era Statement of Attorney General Eric Holder Regarding United States V. Theodore F. Stevens By www.justice.gov Published On :: Wed, 1 Apr 2009 08:54:26 EDT “In connection with the post-trial litigation in United States v. Theodore F. Stevens, the Department of Justice has conducted a review of the case, including an examination of the extent of the disclosures provided to the defendant. After careful review, I have concluded that certain information should have been provided to the defense for use at trial. In light of this conclusion, and in consideration of the totality of the circumstances of this particular case, I have determined that it is in the interest of justice to dismiss the indictment and not proceed with a new trial." Full Article OPA Press Releases
era Justice Department Asks Federal Court to Shut Down Iowa Tax Preparation Firm By www.justice.gov Published On :: Wed, 1 Apr 2009 14:38:44 EDT The United States has brought suit in federal court against Gayle Lemmon of Humboldt, Iowa. The lawsuit seeks to bar her and her firm from preparing federal tax returns for others. According to the government complaint in the case, Lemmons firm, Gayles Bookkeeping and Tax Service Inc., prepares federal income tax returns for customers that unlawfully understate tax liabilities by claiming improper deductions for the business use of the home and for non-deductible personal expenses. Full Article OPA Press Releases
era Former Member of U.S. Navy Sentenced to 10 Years in Federal Prison for Disclosing Classified Information By www.justice.gov Published On :: Fri, 3 Apr 2009 14:57:08 EDT Nora R. Dannehy, Acting U.S. Attorney for the District of Connecticut, and other federal officials announced that Hassan Abu-Jihaad, formerly known as Paul R. Hall, 33, of Phoenix, Arizona, was sentenced today by U.S. District Judge Mark R. Kravitz in New Haven to 120 months of imprisonment, followed by three years of supervised release, for disclosing previously classified information relating to the national defense. Full Article OPA Press Releases
era Statement from Department of Justice Regarding Federal Law Enforcement Response to Binghamton, N.Y., Shootings By www.justice.gov Published On :: Fri, 3 Apr 2009 14:49:40 EDT The Department of Justice, through the FBI and Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), is providing federal law enforcement assistance to the Binghamton Police Department in response to the shootings in Binghamton. The FBIs Albany, N.Y., field office has sent hostage negotiators, an evidence response team and command post assistance. ATF is providing seven special agents from the Syracuse and Albany field offices. The Department will continue to provide assistance as requested in response to this rapidly developing situation. Full Article OPA Press Releases
era Federal, State Partners Announce Multi-Agency Crackdown Targeting Foreclosure Rescue Scams, Loan Modification Fraud By www.justice.gov Published On :: Mon, 6 Apr 2009 11:21:17 EDT 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. Full Article OPA Press Releases
era Former Bristol-Myers Squibb Senior Executive Pleads Guilty for Role in Dishonest Dealings with the Federal Government By www.justice.gov Published On :: Mon, 6 Apr 2009 15:18:13 EDT A former senior executive of Bristol-Myers Squibb Company (BMS), Andrew Bodnar, pleaded guilty for his role in BMSs dishonest dealings with the federal government relating to a patent deal involving the popular blood-thinning drug Plavix. This plea agreement follows BMSs June 11, 2007, agreement to plead guilty and pay a $1 million criminal fine the maximum fine permitted by statute for misleading the government about the Plavix patent deal. Full Article OPA Press Releases
era Ship Operator Pleads Guilty and Agrees to Pay $2.5 Million Fine for Concealing Vessel Pollution By www.justice.gov Published On :: Mon, 6 Apr 2009 18:07:36 EDT Consultores De Navegacion, a Spanish company that operates the M/T Nautilus, an ocean-going chemical tanker ship, pleaded guilty today in U.S. District Court in Boston and has agreed to pay a fine of $2.5 million for criminal violations related to the overboard discharge of oil-contaminated bilge waste on the high seas. Full Article OPA Press Releases
era Federal Court Bars Homewood, Illinois, Tax Preparers from Preparing Federal Tax Returns for Others By www.justice.gov Published On :: Thu, 9 Apr 2009 17:15:41 EDT U.S. District Court Judge Robert W. Gettlemen entered an order barring tax preparers, Michael J. Singleton and his wife, Ladonna Singleton, from preparing federal tax returns for others. The court’s ruling came after the Singletons failed to defend against the government’s allegations. Full Article OPA Press Releases
era Federal Court Blocks Chicago Tax Preparation Firm from Claiming Improper Tax Credits By www.justice.gov Published On :: Thu, 9 Apr 2009 17:41:10 EDT 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. Full Article OPA Press Releases
era Louisiana Tax Defier Convicted on Federal Tax Charges By www.justice.gov Published On :: Fri, 10 Apr 2009 10:51:46 EDT Following three and a half days of trial and 19 minutes of deliberations, a Gulfport, Miss., federal jury yesterday convicted Paul Richard Arceneaux, a resident of Church Point, La., of tax crimes. Arceneaux, who owned and operated Speedy Cash Inc. in Gulfport, was convicted of all counts of the indictment charging him with corruptly interfering with the Internal Revenue laws and failing to file his income tax returns for 2003 and 2004. Full Article OPA Press Releases
era St. Louis Woman Pleads Guilty to Federal Sex Trafficking Charge By www.justice.gov Published On :: Mon, 13 Apr 2009 16:40:19 EDT Waquita Wallace pleaded guilty to the federal civil rights charge of sex trafficking. Wallace admitted to forcing a young woman to engage in commercial sex acts through a combination of force, fraud and coercion. Defendant Wallace also benefitted financially from the sex trafficking. She faces a maximum sentence of life in prison and a fine of up to $250,000. Full Article OPA Press Releases
era Former Oklahoma Deputy Sheriff Indicted for Federal Civil Rights and Obstruction of Justice Violations By www.justice.gov Published On :: Wed, 15 Apr 2009 16:58:53 EDT Ben Milner, a former deputy sheriff with the Choctaw County, Okla., Sheriffs Department, has been indicted by a federal grand jury for violating the civil rights of a man during a traffic stop and the civil rights of two inmates at the Choctaw County Jail. The grand jury also indicted Milner on two counts of obstructing justice in connection with the incident involving the inmates. Full Article OPA Press Releases
era Former Gary, Indiana, Police Chief Sentenced for Federal Civil Rights Violation By www.justice.gov Published On :: Thu, 16 Apr 2009 15:23:46 EDT WASHINGTON Acting Assistant Attorney General Loretta King of the Civil Rights Division announced today that Thomas Houston, former Chief of the Gary, Ind., Police Department, was sentenced to 41 months in prison followed by two years of supervised release for violating the civil rights of a Gary resident in June 2007. Full Article OPA Press Releases
era Federal Court Bars Bloomfield, Connecticut Tax Preparer from Preparing Tax Returns By www.justice.gov Published On :: Thu, 16 Apr 2009 17:33:58 EDT A federal court has permanently barred Donald Morris of Bloomfield, Conn., from preparing federal income tax returns for others. Morris consented to the permanent injunction order, which was entered by U.S. District Court Judge Jane C. Hall in the U.S. District Court for the District of Connecticut. Full Article OPA Press Releases
era West Virginia Man Pleads Guilty on Federal Civil Rights Charges By www.justice.gov Published On :: Mon, 20 Apr 2009 15:38:52 EDT Daryl Lee Fierce, 69, of Charleston, W.Va., pleaded guilty today to a civil rights charge in federal court in the Southern District of West Virginia for using fire to intimidate and interfere with a persons housing rights. Fierce set fire to the victims home because African-American and biracial individuals visited the victim in her home. Full Article OPA Press Releases