pro FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients By www.pharmafile.com Published On :: Mon, 04 May 2020 11:31:55 +0000 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. Full Article coronavirus COVID-19 FDA Gilead remdesivir Sales and Marketing
pro Lonza and Moderna enter agreement to mass produce coronavirus vaccine By www.pharmafile.com Published On :: Mon, 04 May 2020 11:43:10 +0000 Lonza Group AG and Moderna Inc have entered a deal to develop 1 billion doses of coronavirus vaccines a year. Full Article coronavirus COVID-19 Sales and Marketing
pro AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction By www.pharmafile.com Published On :: Wed, 06 May 2020 11:28:32 +0000 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. Full Article AstraZeneca farxiga FDA heart failure Research and Development Sales and Marketing
pro FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14 By www.pharmafile.com Published On :: Thu, 07 May 2020 11:35:49 +0000 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. Full Article Incyte Novartis pharma Tabrecta Sales and Marketing
pro Imperial College London to lead major coronavirus home testing programme By www.pmlive.com Published On :: Fri, 01 May 2020 12:39:45 +0100 Aims to track the progress of the infection across the UK Full Article
pro Roche’s COVID-19 antibody test approved for emergency use in the US By www.pmlive.com Published On :: Mon, 04 May 2020 12:25:11 +0100 Ramps up capacity for testing across the country Full Article
pro Glutagenic Virus Protection Kit By www.flickr.com Published On :: Thu, 07 May 2020 08:13:37 -0700 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. Full Article
pro CBD Product - Patriot Hemp Company By www.flickr.com Published On :: Fri, 08 May 2020 11:07:04 -0700 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. Full Article
pro Protection Blend By www.flickr.com Published On :: Fri, 08 May 2020 11:07:05 -0700 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. Full Article
pro Oxford COVID-19 vaccine programme opens for clinical trial recruitment By www.pharmanews.eu Published On :: Thu, 23 Apr 2020 10:00:00 +0200 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. Full Article Featured Research Research & Development
pro India remains on USTR list of IP problem countries By www.thepharmaletter.com Published On :: Mon, 04 May 2020 16:58:00 +0100 India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of… Full Article Focus On/Generics/India/Intellectual property law/Legal/Patents & Trademarks/USA
pro European progress in long path for Lokelma By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:08:00 +0100 The European medicines regulator has OK’d a label update for AstraZeneca’s Lokelma (sodium zirconium… Full Article AstraZeneca/Biotechnology/Cardio-vascular/Drug Trial/Europe/European Medicines Agency/Focus On/Lokelma/Regulation/Research/UK
pro EU brings production home amid supply chain worries By www.thepharmaletter.com Published On :: Tue, 05 May 2020 14:37:00 +0100 Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,… Full Article Europe/Evonik/Generics/Germany/Production
pro BRIEF—US court upholds Amgen Kyprolis patent By www.thepharmaletter.com Published On :: Tue, 05 May 2020 14:43:00 +0100 The US District Court in Delaware issued a decision upholding the validity of patent claims from three… Full Article Amgen/Biotechnology/Cipla/Focus On/Kyprolis/Legal/Oncology/Patents & Trademarks/USA
pro Regeneron rockets as financial results provide perfect picture of growth By www.thepharmaletter.com Published On :: Tue, 05 May 2020 17:29:00 +0100 Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter… Full Article Anti-virals/Biotechnology/Dermatologicals/Dupixent/Eylea/Financial/Immuno-oncology/Inflammatory diseases/Libtayo/Management/Oncology/Ophthalmics/Regeneron/REGN-COV2/USA
pro FDA approval for Farxiga in new indication in heart failure patients By www.thepharmaletter.com Published On :: Wed, 06 May 2020 14:59:00 +0100 Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and… Full Article AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA
pro 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
pro Japan grants ‘exceptional’ approval for remdesivir in COVID-19 By www.thepharmaletter.com Published On :: Fri, 08 May 2020 14:53:00 +0100 As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,… Full Article Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury
pro With the world waiting, Roche socks $459M into COVID-19 antibody test production By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:05:01 +0000 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. Full Article
pro AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go By www.fiercepharma.com Published On :: Tue, 05 May 2020 17:50:19 +0000 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. Full Article
pro China approves Novartis' multiple sclerosis treatment Mayzent By feeds.reuters.com Published On :: Sat, 09 May 2020 03:29:42 -0400 Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday. Full Article healthNews
pro Canadian Company to Pay U.S. More Than $1 Million Related to Sale of Defective Bullet-proof Vests By www.justice.gov Published On :: Fri, 23 Jan 2009 16:03:49 EST 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. Full Article OPA Press Releases
pro 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
pro U.S. Court Rejects Two Prominent L.A. Real Estate Investors Attempt to Use Tax Avoidance Scheme By www.justice.gov Published On :: Thu, 5 Feb 2009 19:16:20 EST 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. Full Article OPA Press Releases
pro Five Defendants Convicted of International Sex Trafficking for Forcing Central American Girls and Women into Prostitution By www.justice.gov Published On :: Thu, 12 Feb 2009 10:17:12 EST 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. Full Article OPA Press Releases
pro AT&T Technical Services Corp. to Pay U.S. more than $8.2 Million to Settle False Claims Involving the E-Rate Program By www.justice.gov Published On :: Fri, 13 Feb 2009 18:47:23 EST 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. Full Article OPA Press Releases
pro UBS Enters into Deferred Prosecution Agreement By www.justice.gov Published On :: Wed, 18 Feb 2009 16:59:25 EST UBS AG, Switzerlands 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 UBSs cross-border business. Full Article OPA Press Releases
pro BP Products to Pay Nearly $180 Million to Settle Clean Air Violations at Texas City Refinery By www.justice.gov Published On :: Thu, 19 Feb 2009 16:04:38 EST 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. Full Article OPA Press Releases
pro Kentucky Man Pleads Guilty to Producing Child Pornography and Is Sentenced to 20 Years By www.justice.gov Published On :: Thu, 19 Feb 2009 15:03:25 EST 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. Full Article OPA Press Releases
pro N.J. Electrical Company Employee Pleads Guilty to Defrauding the Environmental Protection Agency at Superfund Site By www.justice.gov Published On :: Thu, 26 Feb 2009 12:31:51 EST 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. Full Article OPA Press Releases
pro United States Files Suit Against Missouri-Based Pharmaceutical to Block Manufacturing and Shipping of Unapproved Drugs By www.justice.gov Published On :: Mon, 2 Mar 2009 15:30:05 EST 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. Full Article OPA Press Releases
pro U.S. Asks Courts in California & South Carolina to Shut Down Promoters of Allegedly Fraudulent $39.2 Million Tax Refund Scam By www.justice.gov Published On :: Thu, 5 Mar 2009 11:12:25 EST 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. Full Article OPA Press Releases
pro Illinois Man Convicted for Production, Receipt and Possession of Child Pornography, as Well as Bank Fraud By www.justice.gov Published On :: Mon, 9 Mar 2009 16:10:24 EDT 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. Full Article OPA Press Releases
pro U.S. Department of Justice Promotes International Network to Combat Intellectual Property Crime By www.justice.gov Published On :: Wed, 11 Mar 2009 10:57:51 EDT 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. Full Article OPA Press Releases
pro Four Arrested in Killings of Eagles and Other Protected Birds By www.justice.gov Published On :: Fri, 13 Mar 2009 12:27:09 EDT 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. Full Article OPA Press Releases
pro Justice Department Announces Agreement to Protect Rights of Military and Overseas Voters in New York Special Congressional Election By www.justice.gov Published On :: Thu, 26 Mar 2009 17:29:37 EDT 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 states March 31, 2009, special election in the 20th Congressional District. Full Article OPA Press Releases
pro U.S. Sues 32 Individuals, Alleging $30 Million Tax Credit Scam Based on Sham Sales from Non-Existent Methane Production Facilities at Landfills By www.justice.gov Published On :: Thu, 2 Apr 2009 14:08:05 EDT 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. Full Article OPA Press Releases
pro Two Individuals Convicted on Charges of Conspiracy and Bribery in Connection with a U.S. Army Corps of Engineers New Orleans Levee Reconstruction Project By www.justice.gov Published On :: Thu, 2 Apr 2009 18:03:49 EDT 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. Full Article OPA Press Releases
pro 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
pro United States Announces Largest Settlement Under Environmental Protection Agencys Audit Policy By www.justice.gov Published On :: Mon, 13 Apr 2009 13:59:45 EDT 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. Full Article OPA Press Releases
pro Border Patrol Agent Pleads Guilty for Attempting to Receive Protected Leopard Tortoises By www.justice.gov Published On :: Tue, 14 Apr 2009 12:13:21 EDT 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). Full Article OPA Press Releases
pro Utah Natural Gas Producers Agree to Air Emission Reductions, Conservation Practices By www.justice.gov Published On :: Fri, 17 Apr 2009 14:42:27 EDT 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 & Full Article OPA Press Releases
pro Promoter of Fraudulent Tax Defiance Scheme Pleads Guilty to Mail Fraud By www.justice.gov Published On :: Fri, 24 Apr 2009 16:13:26 EDT 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. Full Article OPA Press Releases
pro Colombian National Arraigned on Charges of Providing Material Support to the FARC By www.justice.gov Published On :: Mon, 27 Apr 2009 16:55:27 EDT 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. Full Article OPA Press Releases
pro Chinese Baby Furniture Company Pleads Guilty to Smuggling Internationally Protected Wood By www.justice.gov Published On :: Fri, 1 May 2009 16:52:22 EDT 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. Full Article OPA Press Releases
pro U.S. Intervenes in Suit Against Former Beef Suppliers to National School Lunch Program By www.justice.gov Published On :: Fri, 1 May 2009 17:39:21 EDT 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. Full Article OPA Press Releases
pro 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 By www.justice.gov Published On :: Fri, 1 May 2009 17:11:18 EDT "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." Full Article Speech
pro 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 By www.justice.gov Published On :: Mon, 11 May 2009 15:28:20 EDT 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. Full Article OPA Press Releases
pro 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 By www.justice.gov Published On :: Mon, 11 May 2009 16:36:46 EDT "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." Full Article Speech
pro Antitrust Division Announces Initiative to Help Protect Recovery Funds from Fraud, Waste and Abuse By www.justice.gov Published On :: Tue, 12 May 2009 14:26:41 EDT 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. Full Article OPA Press Releases