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Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.




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Teva’s cancer drug Bendeka protected from generics until 2031, judge rules

A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.




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Trump vows to reduce America’s reliance on foreign drug imports

President Donald Trump has vowed to cut the US’s reliance on foreign drugs, singling out China and Ireland as countries he wants to stop buying pharmaceuticals from.




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Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer

Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone.




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MHRA launches new pharmacovigilance reporting platform for COVID-19 treatments

A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the pandemic disease.




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Jonathan Freve joins Galecto as Chief Financial Officer

The biotech company Galecto Inc have appointed Jonathan Freve as its Chief Financial Officer, and in his role he will lead financial operations including overseeing investor relations and fundraising efforts.  

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  • Manufacturing and Production

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

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




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Elanco to Buy Bayer's Animal Health Business for $7.6 Billion

Click to view a price quote on ELAN.




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Supercomputer simulations present potential active substances against coronavirus

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




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Pre-filled Syringes San Francisco Conference 2020

14 - 15 September 2020, San Francisco, USA.
The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry.




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Menarini nabs hematologic malignancy drug along with buy of Stemline

Privately-held pharma and diagnostics firm Menarini Group has announced a definitive agreement to acquire…



  • Biotechnology/Companies
  • mergers and acquisitions/Elzonris/Hematology/Italy/Menarini Group/Oncology/One to Watch Companies/Rare diseases/Stemline Therapeutics/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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Alexion exceeds earnings estimates but drops guidance

US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…



  • Alexion Pharmaceuticals/Autoimmune Disorders/Biotechnology/Financial/Immunologicals/Management/Rare diseases/Soliris/Strensiq/Ultomiris/USA

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An important option in the fight against antimicrobial resistance

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Merck & Co/Recarbrio/Regulation/Research/US FDA/USA

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Checkpoint blocker plus chemo shows impact in lung cancer

A multi-year collaboration between China’s Innovent Biologics and USA-based Eli Lilly is bearing fruit,…



  • Biotechnology/China/Drug Trial/Eli Lilly & Company/Gemzar/Immuno-oncology/Innovent Biologics/Research/Tyvyt/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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B-MS’ quarterly financials exceed estimates

US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,…



  • Bristol-Myers Squibb/Cardio-vascular/Celgene/Eliquis/Financial/Hematology/Immuno-oncology/Immunologicals/Management/Oncology/Opdivo/Orencia/Pharmaceutical/Pomalyst/Revlimid/USA

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FDA backs Retevmo for certain lung and thyroid cancers

The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules…



  • Biotechnology/Eli Lilly/Focus On/Immuno-oncology/Loxo Oncology/Oncology/Regulation/Retevmo/selpercatinib/US FDA/USA

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Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.




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Roche's Kadcyla wins NICE backing in early breast cancer use

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting.




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Former Finance Director of California Valve Company Pleads Guilty to Bribing Foreign Government Officials

The former finance director of an Orange County, Calif.-based valve company pleaded guilty today in connection with his role in a conspiracy to pay approximately $628,000 in bribes to numerous foreign government officials.



  • 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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Statement from Matthew A. Miller, Director of the Office of Public Affairs, Regarding Issuance of the National Research Council’s Report on Forensic Science

We appreciate the diligent work of the National Research Council’s committee on forensic science in preparing this report. The Department of Justice’s principal focus in dealing with forensic evidence is on applying it dispassionately to law enforcement challenges, and we regularly use forensics to not only convict the guilty, but also to exonerate the innocent.



  • OPA Press Releases

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Justice Department Files Lawsuit Against the Chicago Board of Education for Alleged Pregnancy Discrimination

The Department of Justice today filed a lawsuit against the Board of Education of the City of Chicago (Board), alleging pregnancy discrimination in employment against former elementary school teacher Traci Meziere.



  • OPA Press Releases

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Falls Church, Va., Man Pleads Guilty to Harboring Indonesian Aliens for Financial Gain

Soripada Lubis, a naturalized American citizen originally from Indonesia, pleaded guilty today to harboring illegal aliens for commercial advantage and private financial gain. Lubis’ wife, Siti Chadidjah Siregar, a citizen of Indonesia, pleaded guilty to making false statements to federal agents who were investigating the scheme.



  • OPA Press Releases

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Stanford Financial Group Chief Investment Officer Charged with Obstruction

Laura Pendergest-Holt, the chief investment officer of Houston-based Stanford Financial Group (SFG), was arrested today by agents of the FBI’s Houston Field Office on a criminal complaint charging her with obstruction of a proceeding before an agency of the United States. Pendergest-Holt will make her initial appearance on Friday, Feb. 27, 2009, before U.S. Magistrate Mary Milloy at the federal courthouse in Houston.



  • OPA Press Releases

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Former Department of Energy Employee Pleads Guilty to Falsifying Performance Evaluation for Monetary Award

A former U.S. Department of Energy (DOE) employee who falsified his performance evaluation to justify an annual performance award to which he was not entitled pleaded guilty today to one count of making false statements.



  • OPA Press Releases

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Former National Century Financial Enterprises CEO Sentenced to 30 Years in Prison, Co-Owner Sentenced to 25 Years in Prison for Conspiracy, Fraud and Money Laundering

Two former National Century Financial Enterprises (NCFE) executives were sentenced today for their roles in a scheme to deceive investors about the financial health of NCFE. NCFE, formerly based in Dublin, Ohio, was one of the largest healthcare finance companies in the United States until it filed for bankruptcy in November 2002.



  • OPA Press Releases

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Three Defendants Sentenced in "Advance-Fee" Fraud Scheme That Cost Victims More Than $1.2 Million

Three defendants were sentenced to prison today after pleading guilty in January 2008 to federal charges of running an “advance-fee” scheme that targeted U.S. victims with promises of millions of dollars.



  • 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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Former Head Securities Trader for Lancer Group Hedge Funds Pleads Guilty to Conspiracy to Commit Mail, Wire and Securities Fraud

The former head securities trader for Lancer Group hedge funds pleaded guilty on April 28, 2009, to one count of conspiracy to commit mail, wire and securities fraud. Eric Hauser, 65, pleaded guilty before U.S. District Court Judge Adalberto Jordan in Miami. Hauser admitted to participating in a scheme to manipulate trading of stocks owned by the Lancer Group hedge funds.



  • 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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Stanford Financial Group Chief Investment Officer Charged with Obstruction of Justice

A federal grand jury in Houston returned a two-count indictment today charging Laura Pendergest-Holt, the chief investment officer of Houston-based Stanford Financial Group (SFG), with conspiring to obstruct a U.S. Securities and Exchange Commission (SEC) proceeding investigating SFG, as well as a substantive count of obstructing the SEC proceeding.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against Sheriff of Hendry County, Florida, Alleging Pregnancy Discrimination

The Department today has entered into a consent decree that, if approved by the U.S District Court in Fort Myers, Fla., will resolve its complaint against the Sheriff of Hendry County, Fla., and the Hendry County Board of County Commissioners.



  • OPA Press Releases

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Justice Department Settles Pregnancy Discrimination Lawsuit Against the Board of Education of the City of Chicago

The Department today has entered into a settlement agreement with the city of Chicago’s Board of Education that, if approved and entered by the court, will resolve a complaint of pregnancy discrimination filed by the United States against the board under Title VII of the Civil Rights Act of 1964.



  • OPA Press Releases

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Former Enron Broadband Chief Financial Officer Pleads Guilty to Falsifying Books and Records

Kevin Howard, former chief financial officer and vice president of finance for Enron Broadband Services (EBS), Enron’s failed telecommunications business, pleaded guilty today to falsifying books and records.



  • OPA Press Releases

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Deputy Attorney General David W. Ogden at the Compliance Week Keynote Address

"The current financial crisis requires a well-coordinated, proactive law enforcement response that draws on all the resources of the federal government. The appropriate role of the Department of Justice in responding to this crisis is clear: We will be relentless in our investigation of corporate wrongdoing, and will not hesitate to bring charges, where appropriate, for criminal misconduct on the part of businesses and business executives."




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United States Files False Claims Act Suit Against California Mortgage Lender Capmark Finance

The Department filed suit against California mortgage lender Capmark Finance Inc., charging that Capmark violated the False Claims Act by making false statements on applications for federal mortgage insurance covering residential nursing homes.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against the Sheriff of Bryan County, Oklahoma, Alleging Pregnancy Discrimination

The Department today entered into a consent decree with the sheriff of Bryan County, Okla., that, if approved by the U.S. District Court in Muskogee, Okla., will resolve the Department’s employment discrimination complaint against the Sheriff, also filed today with the court.



  • OPA Press Releases

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Stanford Financial Group CFO Pleads Guilty to Charges Related to $7 Billion Scheme to Defraud Investors

James M. Davis, 60, the former chief financial officer of Houston-based Stanford Financial Group (SFG), pleaded guilty today to fraud and obstruction charges related to a $7 billion scheme to defraud investors.



  • OPA Press Releases

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Former Global Director of Security for Stanford Financial Group Indicted for Obstructing a Federal Investigation

Thomas Raffanello, a former global director of security at the Fort Lauderdale, Fla., office of Stanford Financial Group (SFG), has been charged today in a three-count superseding indictment with conspiracy to obstruct a U.S. Securities and Exchange Commission (SEC) proceeding and to destroy documents in a federal investigation; obstruction of a proceeding before the SEC; and destruction of records in a federal investigation.



  • OPA Press Releases

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Justice Department Settles Allegations of Religion Discrimination Against Guideone Mutual Insurance Co.

The Department announced a settlement that, pending court approval, will resolve allegations that the GuideOne Mutual Insurance Company and two authorized agents discriminated because of religion when they advertised special benefits and discounts only to “churchgoers” and “persons of faith.”



  • OPA Press Releases

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Associate Attorney General Tom Perrelli's Testimony "Advancing Freedom of Information in the New Era of Responsibility"

"We at the Department are especially committed to encouraging compliance with the Act and to fulfilling President Obama's goal of making this Administration the most open and transparent in history."




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D.C. Lobbyist Indicted for Conspiring to Violate Sudanese Sanctions and to Act as Illegal Agent of Sudan

Robert J. Cabelly, 61, of Washington, D.C., has been indicted in the District of Columbia charging him with conspiracy to violate the Sudanese sanctions regulations and to act as an unregistered agent of a foreign power.



  • OPA Press Releases

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Financial Products and Services Firm, Two Executives and One Former Executive Indicted for Roles in Conspiracies Involving Proceeds of Municipal Bonds

A Beverly Hills, Calif.-based financial products and services firm, two of its executives and one former executive were indicted today for their participation in bid-rigging and fraud conspiracies related to contracts for the investment of municipal bond proceeds and other related municipal finance contracts.



  • OPA Press Releases

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Michigan Attorney and Client Sentenced for Tax Crimes in Connection with a Fraudulent Insurance Tax Shelter

John A. Campbell, a resident of Portage, Mich., was sentenced to 60 months in prison today by the Honorable Janet T. Neff of the U.S. District Court in the Western District of Michigan for conspiring to defraud the United States.



  • OPA Press Releases

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President Obama Establishes Interagency Financial Fraud Enforcement Task Force

“This task force’s mission is not just to hold accountable those who helped bring about the last financial meltdown, but to prevent another meltdown from happening,” Attorney General Eric Holder said.



  • OPA Press Releases

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Attorney General Eric Holder Speaks at the Financial Fraud Enforcement Task Force Press Conference

"We will be relentless in our investigation of corporate and financial wrongdoing, and will not hesitate to bring charges, where appropriate, for criminal misconduct on the part of businesses and business executives."




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Justice Department Files Lawsuit Against MasTec Advanced Technologies to Enforce the Employment Rights of Army Reserve Member

The department filed a lawsuit in federal court in West Virginia alleging that MasTec Advanced Technologies willfully violated the Uniformed Services Employment and Reemployment Rights Act of 1994 by discriminating against a U.S. Army Reserve member on the basis of his military service and by failing to offer Burress an appropriate reemployment position when he returned from military service.



  • OPA Press Releases