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Dr Reddy's gets FDA nod for migraine drug Elyxyb

Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker…



  • Analgesia/celecoxib/Dr Reddy's Laboratories/Elyxyb/Focus On/India/Migraine/Neurological/Pharmaceutical/Regulation/US FDA/USA

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Recordati 1st-qtr revenues rise 12% as income leaps more than 20%

Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2…



  • Financial/Italy/Pharmaceutical/Recordati/Signifor

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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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Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal

Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.




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Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says

After his surprise removal from HHS’ Biomedical Advanced Research and Development Authority—a key agency partnered with pharma companies on COVID-19 drugs, vaccines and diagnostics—former Director Rick Bright is alleging whistleblower retaliation by HHS leadership. 




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AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes

AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line. 




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Amgen ramps up Otezla expansion effort with positive data in mild psoriasis

Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.




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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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Russia records more than 10,000 new coronavirus cases in past day

Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676.




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Tokyo reports 36 new cases of coronavirus infection on Saturday: TV Asahi

Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100.




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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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Half of Spaniards will see lockdown eased from Monday as death toll falls

Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns.




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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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Best of the Best Biotech Book Recommendations

As you may know, I maintain an extensive list of book recommendations for the biotech enthusiast on a "Amazon Influencer" page. After the latest update there are well over 100 titles! I recently analyzed the data to come up with the most popular titles among my followers (perhaps the full list is a bit intimidating):​Genentech: The Birth of BiotechThe Biotech Trader HandbookThe Pharmagellan Guide to Biotech Forecasting & ValuationValuation in Life Sciences: A Practical GuideThe Antidot [...]




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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.



  • OPA Press Releases

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Twentieth Member of Casino-cheating Criminal Enterprise Pleads Guilty to Racketeering Conspiracy Targeting Casinos in the United States and Canada

Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats.



  • OPA Press Releases

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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).



  • OPA Press Releases

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Defendant Pleads Guilty to Conspiring to Export Military Aircraft Parts to Iran

Hassan Saied Keshari and his corporation, Kesh Air International, pleaded guilty this morning in the Southern District of Florida to charges of conspiring to illegally export military and commercial aircraft parts to Iran. 



  • OPA Press Releases

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Former NFL Player, Ex-Casino Owner and Nevada Businessman Indicted in Massive Tax Fraud Scheme

A Las Vegas federal grand jury has returned an indictment charging Alan Rodrigues, a former pit boss and casino owner from Henderson, Nev.; Weston Coolidge, a businessman from Las Vegas; and Joseph Prokop, a former National Football League punter from Upland, Calif., with a tax fraud scheme for their promotion of a fraudulent tax product through the now defunct National Audit Defense Network (NADN).



  • OPA Press Releases

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Justice Department Files Lawsuit on Behalf of North Dakota Army National Guard Member

The Department today filed a lawsuit on behalf of Suzanne L. Halverson, an Army National Guard member, against Grand Forks County, N.D., alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), which prohibits employers from discriminating against service-members because of their past, current or future military service obligations.



  • OPA Press Releases

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Final Defendant Pleads Guilty to Anti-Obama Assaults

Ralph Nicoletti pleaded guilty in Brooklyn, N.Y., federal court today before U.S. District Judge Carol B. Amon to committing three assaults targeting African-American residents in Staten Island, N.Y., on the night of President Barack Obama’s election victory. Nicoletti was the last of four defendants to plead guilty in the federal prosecution stemming from the attacks.



  • 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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Former Velda City, Mo., Reserve Police Officer Pleads Guilty to Civil Rights and Obstruction Charges

A former Velda City, Mo., auxiliary reserve police officer pleaded guilty today to violating the federal civil rights of a woman he sexually assaulted during a traffic stop and to concealing evidence of his crime from federal investigators. According to facts presented in court, on or about July 9, 2006, Joe Ernest Phillips, 38, then an auxiliary reserve police officer for the Velda City Police Department sexually assaulted a woman while acting under color of law and deprived her of her civil rights.



  • OPA Press Releases

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

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



  • OPA Press Releases

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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.



  • OPA Press Releases

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Co-Founder of Casino-Cheating Criminal Enterprise Pleads Guilty to Racketeering Conspiracy Targeting Casinos in the United States and Canada

Tai Khiem Tran, 47, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat casinos across the United States and Canada. Tran admitted that he and his co-conspirators unlawfully obtained up to $1 million during card cheats.



  • OPA Press Releases

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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.



  • OPA Press Releases

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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.



  • OPA Press Releases

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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.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against the City of Dayton, Ohio, Alleging Discrimination Against African Americans in the Hiring of Police Officers and Firefighters

The Department announced today that it has entered into a consent decree with the city of Dayton that, if approved by the court, will resolve the Department’s complaint that Dayton has been engaged in a pattern or practice of discrimination against African-Americans in its hiring of entry-level police officers and firefighters, in violation of Title VII of the Civil Rights Act of 1964 (Title VII).



  • OPA Press Releases

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Five Defendants Sentenced for Participation in International Child Exploitation Enterprise

Five U.S. defendants convicted for their activity in a global child pornography trafficking enterprise were sentenced today in the Northern District of Florida. The defendants had pled to multiple charges, including engaging in a child exploitation enterprise; conspiracy to advertise, transport, ship, receive and possess child pornography; advertising child pornography; transporting child pornography; and receiving child pornography.



  • OPA Press Releases

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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.



  • OPA Press Releases

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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.



  • OPA Press Releases

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Third Defendant Pleads Guilty to Money Laundering Scheme Involving Bribes for Contracts at Kuwait Army Base

The sister of a U.S. Army officer has pleaded guilty for her participation in a money-laundering scheme related to bribes paid for contracts awarded in support of the Iraq war. Carolyn Blake, of Sunnyvale, Texas, pleaded guilty to one count of money laundering conspiracy after accepting more than $3 million in bribe proceeds on behalf of her brother, Major John Cockerham.



  • OPA Press Releases

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Federal Judge Shuts Down Two Dallas Tax Preparers

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 Washington’s former employer, Tina Preston, and her firm, The Preston Group & Associates Inc., from preparing federal tax returns.



  • OPA Press Releases

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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.



  • OPA Press Releases

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Defendant Pleads Guilty to Conspiring to Export Military Aircraft Parts to Iran

Traian Bujduveanu has pleaded guilty in the Southern District of Florida to a charge of conspiring to illegally export military and dual use aircraft parts to Iran. Bujduveanu appeared on behalf of himself and his now defunct corporation, Orion Aviation, in federal court in Miami today to announce his guilty plea.



  • OPA Press Releases

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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.



  • 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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Virginia Physicist Sentenced to 51 Months in Prison for Illegally Exporting Space Launch Data to China and Offering Bribes to Chinese Officials

A physicist in Newport News, Va., was sentenced to 51 months in prison today for illegally exporting space launch technical data and defense services to the People’s Republic of China and offering bribes to Chinese government officials. Shu Quan-Sheng, 68, a native of China, naturalized U.S. citizen and Ph.D. physicist, was sentenced by Judge Henry C. Morgan, Jr. in U.S. District Court for the Eastern District of Virginia, Norfolk Division.



  • OPA Press Releases

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Six Defendants Sentenced for Participation in International Child Exploitation Enterprise

WASHINGTON and PENSACOLA, Fla. – Six U.S. defendants convicted for their activity in a global child pornography trafficking enterprise were sentenced today in the Northern District of Florida, Acting Assistant Attorney General of the Criminal Division Rita M. Glavin, U.S. Attorney for the Northern District of Florida Thomas F. Kirwin and FBI Executive Assistant Director J. Stephen Tidwell announced.



  • OPA Press Releases

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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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Federal Court Shuts Down Dallas Tax Preparer

A federal court in Dallas has permanently barred a Garland, Texas, man from preparing federal tax returns for others. Lucky Ngo, who operated “Lucky’s Translation and Tax Service” and “Water Inn,” prepared over 6,100 federal tax returns for customers since 2004, according to the government complaint filed in the civil injunction case. Ngo agreed to the permanent injunction order.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against Grand Forks County, North Dakota, to Enforce the Employment Rights of North Dakota Army National Guard Member

The Department has reached a settlement that will resolve its lawsuit filed against Grand Forks County, N.D., on behalf of Suzanne L. Halverson in accordance with the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), if approved by the U.S. District Court in Fargo. USERRA prohibits employment discrimination against individuals because of their service in the uniformed services.



  • OPA Press Releases

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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.



  • OPA Press Releases

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Defendant Sentenced to Life for Participation in International Child Exploitation Enterprise

James Freeman of Santa Rosa Beach, Fla., was sentenced to life in prison today for his activity in a global child pornography trafficking enterprise. Freeman, a registered sex offender, was found guilty following a six-day trial in January 2009 of six counts relating to his criminal activities as a member of the child exploitation enterprise.



  • OPA Press Releases

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Two Additional Defendants Sentenced for Conspiring to Kill U.S. Soldiers

The remaining two men convicted of plotting to kill members of the U.S. military during an armed attack on a military base were sentenced today to federal prison terms of life for one defendant and 33 years for the other for conspiring to kill members of the U.S. military. U.S. District Judge Robert B. Kugler sentenced Mohamad Ibrahim Shnewer to a term of life in prison plus an additional, consecutive 30 years. Judge Kugler sentenced Serdar Tatar to 33 years in prison.



  • OPA Press Releases

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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.



  • OPA Press Releases

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

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