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ACRO Urges Modernization of the R&D Tax Credit

WASHINGTON – November 14, 2017 – As the Senate begins debate on a tax reform bill, the clinical research industry hopes that...




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Bayer launches pre-filled syringe to administer eye medication Eylea™ in Europe (for specialized target groups only)




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AstraZeneca success should prompt review of takeover rules | Nils Pratley

Firm’s recent success could have been very different had it been bought out by Pfizer in 2014

It’s perhaps not surprising that the worth of healthcare companies should emerge during a global pandemic, but we should offer thanks for the UK’s big pharma twins – AstraZeneca and GlaxoSmithKline.

The former, with its share price at all-time high, is now jostling with Shell and Unilever for the title of biggest company in the FTSE 100 index. Successful research bets, especially on cancer drugs, have transformed Astra.

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AstraZeneca partners with Oxford University to produce Covid-19 vaccine

Drugmaker will manufacture and distribute vaccine if human trials are successful

AstraZeneca, the Cambridge-based pharmaceutical group, is teaming up with Oxford University to manufacture and distribute a coronavirus vaccine if clinical trials currently under way show it is effective.

News of the partnership boosted AstraZeneca’s share price, helping it to become Britain’s most valuable company by market capitalisation.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

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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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AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine

A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection.



  • Research and Development
  • Manufacturing and Production

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Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.




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Positive CHMP opinion for BMS and Acceleron's Reblozyl in transfusion-dependent anaemia sub-populations

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.




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Lonza and Moderna enter agreement to mass produce coronavirus vaccine

Lonza Group AG and Moderna Inc have entered a deal to develop 1 billion doses of coronavirus vaccines a year.




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Working Life Interview: Kim Stratton, CEO, Orphazyme

"Every professional faces challenges. As a woman in industry, particularly in leadership, it adds another dimension to those challenges in how you present yourself."




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AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

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.




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AstraZeneca partners with Oxford University on UK’s lead coronavirus vaccine

AZ has pledged to make the vaccine at cost for the duration of the pandemic




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Amgen adds Otezla to the COVID-19 candidate list

Psoriasis therapy may be a potential treatment for COVID-19




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US trials of Pfizer/BioNTech coronavirus vaccine start

It is hoped that the drug may prevent COVID-19




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Zinc Charge

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.




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Lannett to Be U.S. Distributor of Posaconazole Delayed-Release Tablets

Click to view a price quote on LCI.




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AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients

AstraZeneca and Saint Luke's Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure.




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AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2.

The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford.




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Pfizer and BioNTech move on COVID-19 vaccine work apace

As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their…



  • BioNTech/BNT162/Coronavirus/Drug Trial/Focus On/Pfizer/Pharmaceutical/Research/USA/Vaccines

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Otezla’s impact shown in milder psoriasis

Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb,…



  • Amgen/Biotechnology/Dermatologicals/Drug Trial/Inflammatory diseases/Otezla/Research/USA

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

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




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China approves Novartis' multiple sclerosis treatment Mayzent

Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday.




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

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




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Minnesota Man Arrested in Connection with Ponzi Scheme

A Minnesota man was arrested today on charges related to an alleged Ponzi scheme involving commodity pools. Charles “Chuck” E. Hays, of Rosemount, Minn., was charged in a criminal complaint filed in the District of Minnesota with one count of wire fraud and one count of mail fraud.



  • OPA Press Releases

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Arizona Man Sentenced to Five Years for Distribution of Child Pornography

Theodore Allan, 54, of Glendale, Ariz., was sentenced today to five years in prison for distribution of child pornography. Allan was indicted on charges of distribution, receipt and possession of child pornography on March 6, 2007.



  • OPA Press Releases

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Justice Department Resolves Lawsuit with State of Vermont Regarding Reporting Requirements of Uniformed and Overseas Citizens Absentee Voting Act

The Department announced today the resolution of the lawsuit filed by the United States against the state of Vermont to enforce the reporting requirements of the Uniformed Overseas Citizen Absentee Voting Act (UOCAVA). UOCAVA is designed to ensure that members of the uniformed services and overseas citizens may effectively participate in federal elections.



  • OPA Press Releases

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Iraqi-Born Dutch Citizen Pleads Guilty to Terrorism Conspiracy Against Americans in Iraq

An Iraqi-born Dutch citizen today pleaded guilty to conspiring with others to murder Americans overseas, including by planting roadside bombs targeting U.S. soldiers in Fallujah, Iraq, and by demonstrating on video how these explosives would be detonated to destroy American vehicles and their occupants.



  • OPA Press Releases

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Two UK Citizens Charged by United States with Bribing Nigerian Government Officials to Obtain Lucrative Contracts as Part of KBR Joint Venture Scheme

Two citizens of the United Kingdom have been charged in an indictment unsealed today in the United States for their alleged participation in a decade-long scheme to bribe Nigerian government officials to obtain engineering, procurement and construction (EPC) contracts. The EPC contracts to build liquefied natural gas (LNG) facilities on Bonny Island, Nigeria, were valued at more than $6 billion.



  • OPA Press Releases

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Arizona Man Pleads Guilty to Receipt of Child Pornography

Charles Brown, 54, of Mesa, Ariz., pleaded guilty today to one count of receiving child pornography. During the plea hearing before U.S. District Judge Paul G. Rosenblatt, Brown admitted to receiving child pornography.



  • OPA Press Releases

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Justice Department Seeks Removal of Pittsburgh-Area Man Who Served as Nazi Concentration Camp Guard

The Department of Justice has initiated removal proceedings against a Sharon, Penn., resident who served as an armed SS guard at two Nazi concentration camps in Germany during World War II.



  • OPA Press Releases

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Minnesota Man Pleads Guilty to Running Ponzi Scheme

A Rosemount, Minn., man has pleaded guilty in connection with running a Ponzi scheme involving commodity pools. Charles “Chuck” E. Hays, 56, pleaded guilty before U.S District Court Judge Donovan Frank on April 14, 2009, in St. Paul, Minn., to one count of mail fraud, one count of wire fraud, and one count of structuring transactions to avoid financial reporting requirements.



  • OPA Press Releases

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Iraqi-Born Dutch Citizen Sentenced to 25 Years in Prison for Terrorism Conspiracy Against Americans in Iraq

An Iraqi-born Dutch citizen was sentenced to 25 years in prison today for conspiring to murder Americans overseas, including by planting roadside bombs targeting U.S. soldiers in Fallujah, Iraq, and by demonstrating on video how these explosives would be detonated to destroy American vehicles and their occupants.



  • OPA Press Releases

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Former Nazi Death Camp Guard John Demjanjuk Deported to Germany

John Demjanjuk, a former Nazi death camp guard and a resident of Seven Hills, Ohio, has been removed by U.S. Immigration and Customs Enforcement (ICE) to Germany. Demjanjuk was removed through a court order of removal obtained by the Department of Justice. On March 10, 2009, a German judge issued an order directing that Demjanjuk, 89, be arrested on suspicion of assisting in the murder of at least 29,000 Jews at the Sobibor extermination center in Nazi-occupied Poland during World War II.



  • OPA Press Releases

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Georgia-Pacific Agrees to Perform Cleanup Activities at the Kalamazoo Superfund Site in Michigan

Georgia-Pacific, a manufacturing company headquartered in Atlanta, has agreed to perform remedial work at an estimated cost of nearly $13 million to contain two former disposal areas within the Kalamazoo River Superfund site in Allegan and Kalamazoo Counties, Mich.



  • OPA Press Releases

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Eight Uzbekistan Nationals Among 12 Charged with Racketeering, Human Trafficking & Immigration Violations in Scheme to Employ Illegal Aliens in 14 States

Twelve defendants, including eight Uzbekistan nationals, have been charged in a 45-count indictment returned by a federal grand jury in Kansas City, Mo., on May 6, 2009, on RICO (Racketeer Influenced and Corrupt Organizations Act) charges related to labor racketeering, forced labor trafficking and immigration and other violations in 14 states.



  • OPA Press Releases

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Christine A. Varney to Participate in Eighth Annual International Competition Network Conference in Zurich, Switzerland

Christine A. Varney, Assistant Attorney General in charge of the Department’s Antitrust Division, will participate in the eighth annual International Competition Network (ICN) conference in Zurich, Switzerland, from June 3-5, 2009. At the conference, senior government antitrust officials, private-sector antitrust experts from around the world, and representatives from intergovernmental organizations will meet to discuss competition issues.



  • OPA Press Releases

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Former Political Action Committee Contractor Pleads Guilty to Embezzling Funds

Melissa Thomas, 34, pleaded guilty today to one count of forgery in connection with a scheme to embezzle more than $17,000 from a political action committee (PAC), which was a client of her employer.



  • OPA Press Releases

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Alabama Resident Pleads Guilty to Filing False Tax Returns in Connection with Embezzlement Scheme

Sims Lawson Jr., a resident of Killen, Ala., pleaded guilty yesterday to filing false tax returns for years 2002 through 2004. Lawson appeared before Judge R. David Proctor in Birmingham, Ala., and admitted that he failed to pay federal income taxes of $369,038 and state income taxes of $50,938.



  • OPA Press Releases

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Retired University Professor Sentenced to Four Years in Prison for Arms Export Violations Involving Citizen of China

John Reece Roth, 72, of Knoxville, Tenn., was sentenced to 48 months in prison for violating the Arms Export Control Act by conspiring to illegally export, and actually exporting, technical information relating to a U.S. Air Force (USAF) research and development contract.



  • OPA Press Releases

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Connecticut Investor Found Guilty in Massive Scheme to Bribe Senior Government Officials in the Republic of Azerbaijan

Frederic A. Bourke Jr., 63, was found guilty today by a federal jury in Manhattan of conspiracy to violate the Foreign Corrupt Practices Act (FCPA) and the Travel Act, and making false statements to the FBI.



  • OPA Press Releases

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United States, UBS and Switzerland Request Stay in Court Proceedings

The Department of Justice, UBS and the Swiss government have requested a stay with a rescheduled hearing date of Aug. 3, 2009, in the proceedings for enforcement of the summons ordering UBS to turn over records of account holders.



  • OPA Press Releases

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Alleged Mexican Cartel Leaders, Associates Targeted in Newest Effort to Combat Drug Trafficking Organizations

Today the Departments of Justice, State and Treasury announced coordinated actions against the Gulf Cartel/Los Zetas drug trafficking organization, now known as the "Company," in the latest in a series of efforts by the U.S. government to neutralize and dismantle this violent cartel.



  • OPA Press Releases

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Deputy Attorney General David W. Ogden Introductory Statement for the Organized Crime Drug Enforcement Task Forces and Asset Forfeiture Program’sNational Leadership Conference

"The Asset Forfeiture Program is critical to our efforts to reduce and deter criminal activity. Your use of civil and criminal forfeiture to seize and forfeit the assets of organized crime targets is essential for this fight."




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Arizona Man Pleads Guilty to Mailing Child Pornography

Robert Restuch, 69, of Bullhead City, Ariz., pleaded guilty yesterday to one count of mailing child pornography. As part of his plea agreement, Restuch admitted that he entered a U.S. Post Office in Bullhead City and mailed a package that contained more than 600 images of child pornography, including images depicting children less than 12 years old.



  • OPA Press Releases

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British Citizen Arrested in Connection with Costa Rica-based Business Opportunity Fraud Ventures

A British citizen charged in connection with the operation of a series of fraudulent business opportunities was arrested Thursday evening in Miami following his indictment by a Miami federal grand jury on June 9, 2009.



  • OPA Press Releases

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Oregon Man Indicted for Dumping Hazardous Waste

Dennis Beetham and his company, D.B. Western Inc., have been indicted on both federal and state charges alleging that he illegally dumped hazardous and other industrial waste in Crook County, Ore.



  • OPA Press Releases

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ICE and DOJ Sign Agreements to Share Information on Drug Trafficking and Organized Crime

U.S. Immigration and Customs Enforcement (ICE) and the U.S. Department of Justice (DOJ) signed two Memoranda of Understanding (MOUs) on Thursday, Aug. 6, 2009, to foster increased communication between participating agencies at the Organized Crime Drug Enforcement Task Force (OCDETF) Fusion Center and the International Organized Crime Intelligence and Operations Center (IOC-2).



  • OPA Press Releases

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Arizona Man Sentenced to Five Years in Prison for Receipt of Child Pornography

Charles Brown, 54, of Mesa, Ariz., was sentenced today to five years in prison and lifetime supervised release following his prison term for receiving child pornography.



  • OPA Press Releases