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Justice Officials Meet with Key Stakeholders on Launch of Elder Justice Website

Earlier today, Associate Attorney General Tony West, Assistant Attorney General Stuart Delery for the Civil Division and members of the Department’s Elder Justice Initiative met with stakeholders in the field of elder abuse and financial exploitation to launch the Elder Justice website.



  • OPA Press Releases

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Justice Department Settles Religious Discrimination Lawsuit Against School District of Philadelphia

The Department of Justice announced today that it has entered into a settlement agreement with the School District of Philadelphia that resolves a religious accommodations lawsuit filed in March 2014. In its lawsuit, the United States alleged that the school district violated Title VII of the Civil Rights Act of 1964 (Title VII) by failing to accommodate the religious beliefs, observances and/or practices of Siddiq Abu-Bakr, a school police officer who is Muslim, and similarly-situated employees who maintain a beard longer than one-quarter inch for religious purposes.



  • OPA Press Releases

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Justice Department Sues to Shut Down Mississippi Tax Return Preparer

The United States has requested that the U.S. District Court for the Northern District of Mississippi permanently bar Nathaniel Kimble, Greenville, Mississippi, man from preparing federal income tax returns for others, the Justice Department announced today.



  • OPA Press Releases

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Statement by the U.S. Department of Justice and the Office of the Director of National Intelligence on the Declassification of Documents Related to the Protect America Act Litigation

On January 15, 2009, the U.S. Foreign Intelligence Surveillance Court of Review (FISC-R) published an unclassified version of its opinion in In Re: Directives Pursuant to Section 105B of the Foreign Intelligence Surveillance Act, 551 F.3d 1004 (Foreign Intel. Surv. Ct. Rev. 2008). The classified version of the opinion was issued on August 22, 2008, following a challenge by Yahoo! Inc. (Yahoo!) to directives issued under the Protect America Act of 2007 (PAA). Today, following a renewed declassification review, the Executive Branch is publicly releasing various documents from this litigation, including legal briefs and additional sections of the 2008 FISC-R opinion, with appropriate redactions to protect national security information. These documents are available at the website of the Office of the Director of National Intelligence (ODNI), www.dni.gov; and ODNI’s public website dedicated to fostering greater public visibility into the intelligence activities of the U.S. Government, IContheRecord.tumblr.com. A summary of the underlying litigation follows.



  • OPA Press Releases

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Justice Department and CNCS Announce $1.8 Million in Grants to Enhance Immigration Court Proceedings and Provide Legal Assistance to Unaccompanied Children

The Department of Justice and the Corporation for National and Community Service (CNCS), which administers AmeriCorps national service programs, has awarded $1.8 million in grants to increase the effective and efficient adjudication of immigration proceedings involving certain children who have crossed the U.S. border without a parent or legal guardian.



  • OPA Press Releases

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Department of Justice and Federal Trade Commission Sign Cooperation Agreement with Colombian Antitrust Agency

Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division has signed an antitrust cooperation agreement with the Colombian antitrust agency on behalf of the Department of Justice. The agreement also was signed by Federal Trade Commission Chairwoman Edith Ramirez, and went into effect today with the signature of Pablo Felipe Robledo, Colombia’s Superintendent of Industry and Commerce.



  • OPA Press Releases

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Justice Department Announces National Effort to Build Trust Between Law Enforcement and the Communities They Serve

Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice.



  • OPA Press Releases

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Justice Department and State Partners Secure $1.375 Billion Settlement with S&P for Defrauding Investors in the Lead Up to the Financial Crisis

Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.



  • OPA Press Releases

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Justice Department Reaches $470 Million Joint State-Federal Settlement with HSBC to Address Mortgage Loan Origination, Servicing and Foreclosure Abuses

The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses



  • OPA Press Releases

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Former SunTrust Mortgage VP and Loan Officers Sentenced to Prison

ALEXANDRIA, Va



  • OPA Press Releases

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Amin Talati Continues its Expansion in Washington DC With Addition Of Dietary Supplement Industry Leader

Rend Al-Mondhiry has joined the firm Amin Talati from the Council for Responsible Nutrition (CRN) as Senior Counsel, resident in the Washington, D.C. Office.




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BASF Launches Breakthrough Absorption Technology as GOED Raises Bioavailability Challenge to Omega-3 Industry

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.




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Parry Nutraceuticals, Valensa Expand Microalgae Plans Through Joint Venture with Synthite Industries

Valensa International announced today a joint venture agreement between Valensa’s parent company EID Parry and Synthite Industries Ltd., expanding plans to lead development and distribution of value-added microalgae extracts.




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The Health Care Practitioner Channel: Connecting Industry and Medical Professionals

Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too.




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‘APEC is at a crossroads; we must chart the way forward’

In scenic Puerto Varas, APEC delegates engaged in constructive dialogue about how to adopt to a changing world.




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Consensus Fosters Sustainable and Inclusive Growth: APEC Senior Officials

Members of the Asia-Pacific Economic Cooperation (APEC) will continue to work together towards more inclusive and sustainable growth, pledged APEC Senior Officials at the concluding event for Chile’s host year of APEC.




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Policies Must Ensure Inclusion and Sustainability: APEC Malaysia 2020

Broaden opportunities for people and ensure more inclusive growth across the Asia-Pacific, urged the 2020 Chair of APEC Senior Officials, host of the Asia-Pacific Economic Cooperation in 2020.




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When is a Customer NOT a Customer?

While patients are consumers of healthcare services, they can’t be considered customers in the traditional sense. The same is true of students. Over many years of teaching, I’ve noticed this parallel between the healthcare and education professions; both require significantly more “customer participation” to achieve desired outcomes than other industries do. That’s one reason it’s difficult to measure the quality of these institutions and the skills of their practitioners. That’s also why both industries focus so intently on engaging our communities; we simply can’t be successful unless we do.

“Can You Hear Me Now?”
As the old joke goes, there are 3 types of people in this world: those who are good at math and those who aren’t. Many students believe themselves to be permanent denizens of the 2nd camp. They find mathematical concepts confusing and the terminology inscrutable, so they tend not to ask questions. They’re afraid they’re being judged, so they’re not always truthful. Tests and exams fill them with anxiety, and sometimes even panic (no doubt waking to nightmares of trains leaving stations at varying rates of speed). These are the students who need my help the most. Our success in overcoming these challenges together will depend heavily on the student/teacher connection we can establish, yet few students are actually able to choose the teacher with whom they are asked to connect. Sound like healthcare yet?



So it’s no surprise that trends toward greater patient engagement in healthcare, and patient-centricity in clinical research, emphasize clear and compassionate communication. Doctors, like instructors, need to explain concepts in relatable terms, encourage and address questions, assuage unwarranted anxiety, and establish trust. Until that happens, a meaningful partnership isn’t even possible.

When the Cat’s Away, Will the Mice Make Good Choices?
You may remember that old college rule of thumb: 1 hour of class requires 3 hours of study. This means instructors have just 25% of their students’ time to inspire the behaviors and habits that will make a success of the other 75%. “Don’t be the Sage on the Stage,” the mantra goes, “be the Guide on the Side.” If you’ve ever taught in an academic setting, you know how challenging that can be. The role of lecturer is fairly obvious, but the role of coach is nuanced; it evolves over time and it’s different for everyone.

And if a college instructor has just 3 hours of face time a week, a physician is lucky to have 3 hours of face time a year. That’s not much time to persuade, convince, and encourage the lifestyle choices and medication adherence essential to maintaining good health. And when you consider that a good part of each office visit is spent performing examinations and assessments, it’s easy to understand the excitement surrounding mobile health technologies. Beyond delivering real-time, real-world data, smartphone apps can send patients important reminders, make complying with diet and exercise recommendations easier, and make progress toward fitness goals visible.

“And the Survey Says…?”
Most service industries are rightly concerned with customer satisfaction – how to achieve it, how to measure it, and how to improve it. So last year, an article entitled “The Problem with Satisfied Patients” caught my eye. The Atlantic article concluded that higher hospital satisfaction ratings don’t necessarily correlate with better healthcare. A five-star student course evaluation can be similarly misleading. Pleasing a student is not the same thing as teaching a student, just as making people happy doesn’t make them well. That’s not to say that hospitals and colleges shouldn’t solicit feedback; of course they need to understand the perspective of the communities they serve. But healthcare facilities and schools should give satisfaction surveys their proper weight or they risk implementing changes that consume resources but do nothing to improve a patient’s health or increase a student’s proficiency.

Outcomes-based Evaluation
So if outcomes are paramount in both medicine and academia, it follows that the quality of care and education would be best measured by evaluating those outcomes. Right?  Well, it’s a good place to start, but since patients and students share responsibility for success with their doctors and teachers, an individual outcome may be misleading. An instructor can influence, but can’t control, whether a student works on practice problems, studies for tests, asks questions, or even pays attention. A doctor can’t control whether a patient takes a prescription, follows medical advice, or reports relevant symptoms. There isn’t always a straight line between quality of service and success rate.


College instructors try to keep their students engaged by tailoring their coaching styles, offering a mix of delivery methods, seeking out fresh ideas to make the concepts relevant, and maintaining convenient office hours. Looking to improve patient engagement, healthcare systems have found that many people face situations that prevent them from keeping appointments and following medical advice. Some organizations are now providing copay assistance, arranging transportation, and employing patient care coordinators to place routine monitoring calls. None of these services are free, but they can be considerably less expensive than eating the costs associated with hospital readmissions.

The Partnership Starts Here
Teachers want their students to learn and healthcare providers want their patients to be well, but students and patients must actively participate in order to meet those goals. Handing out easy A’s and offering gourmet hospital menu items in response to survey responses won’t cut it.

Success begins with clear, compassionate communication – communication designed to explain complex concepts, to build trust, and to encourage the behaviors that lead to positive results. Understanding the challenges students and patients face enables educators and medical professionals to offer practical, meaningful solutions that can actually improve outcomes.

[In case you missed it, our last blog post was about the most common site inspection finding every year for the last decade: Protocol Deviations and How to Avoid Them.]




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FDA approval delayed for Sanofi Genzyme’s next blockbuster

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…




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Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.




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COVID-19 brings new collaborations to Australia and the EU

In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.




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The Pharmaceutical-Biotech-Devices Industries Face a New World Post-Pandemic

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading




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Indian industry doth protest too much

Posted by Roger Bate (on behalf of the authors of the paper) India’s pharmaceutical industry wants its government to sue us because of our “smear campaign” against it (Click here) and if today’s media in India are correct, India’s government is considering it (Click here). This so-called campaign is actually an academic study which identifies uncomfortable data that some Indian companies, or their distributors, seem to be sending inferior medicines to Africa (s [...]




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Why You Can’t Always Trust Your Coronavirus Antibody Test Results

Many people across the country experienced COVID-19 symptoms but could not get a test to confirm if they actually had the virus. Now some are looking to a different kind of coronavirus test for answers.

Antibody tests are meant to recognize a past infection. Many of these have hit the market in recent weeks and are being offered at local clinics. Officials have touted the tests as crucial for reopening the economy and developing public health strategies to contain the virus.

But there are still questions about how accurate they are. And even with a very good test, it's possible to test positive for antibodies even when you don't actually have them. Watch our new video to learn why.




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COVID-19 LATEST: Valproate reviews must not be delayed, says medicines regulator

All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

To read the whole article click on the headline




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Just 550 pharmacy staff referred for COVID-19 testing in first ten days of national scheme

Just over 550 community pharmacy staff members were referred for COVID-19 tests through a national booking system run by the Care Quality Commission, over ten days in mid-April 2020, the NHS watchdog has told The Pharmaceutical Journal.

To read the whole article click on the headline




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PTC Therapeutics nabs 'phase 3 ready' biotech Censa for just $10M upfront plus stock

PTC Therapeutics is adding to its rare disease pipeline with a midstage biotech buyout with a low upfront payment tied in with stock and biobucks.




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CRN’s Mister: ‘This could be a sea change for the industry as consumers take more interest in their health’

Consumers are turning to dietary supplements in record numbers, but the industry must deliver on the results the products are promising if the industry is to convert them to long term customers, says Steve Mister.




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Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading




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Can pharma become a digital industry?



  • in the news
  • Working in the industry
  • Pharma Digital Transformations

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The Check-In: Justin Turner unsettled at thought of not playing again for the Dodgers

The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter.




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Column: The cruise ship industry is sinking. I'm OK with that

Norwegian Cruise Line says it's in danger of going out of business. Maybe that's not the worst thing for an industry of floating petri dishes.




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L.A. Phil's 100th birthday bash: Your quarantine must-watch of the day

It was one of last year's hot tickets: Gustavo Dudamel, Esa-Pekka Salonen and Zubin Mehta, on the same stage at the same time. How to see it for free.




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The ultimate guide to masks: Where travelers must wear them

LAX and many airlines are now requiring face coverings to avoid coronavirus spread. TSA agents will don them too.




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Merchants rejoice as they finally swing open doors and greet customers — with restrictions, of course

Merchants rejoice they finally reopen businesses and greet customers, with social distancing




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Hershey Felder salutes Irving Berlin, plus 13 other must-sees on Mother's Day weekend

Celebrate Mother's Day with a livestream of the musical bio-drama "Hershey Felder as Irving Berlin"




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Just a Decade Later, DEA Reopens Comment Period for Electronic Prescriptions for Controlled Substances

By Karla L. Palmer




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Singapore must rethink how it treats migrant workers




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Indians must stop spreading anti-Muslim fake news on WhatsApp




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China and US must cooperate to lead world out of coronavirus danger




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Presentation Materials of Sustainability Meeting




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Yokogawa Signs Strategic Alliance Agreement with Saudi Basic Industries Corporation

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has entered into a strategic alliance framework agreement to accelerate collaboration with Saudi Basic Industries Corporation (SABIC), ranked among the world's largest petrochemical manufacturers. The agreement includes selection of Yokogawa as a preferred supplier of control systems.




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Yokogawa Releases AI-enabled Versions of SMARTDAC+ Paperless Recorders and Data Logging Software, and Environmentally Robust AI-enabled e-RT3 Plus Edge Computing Platform for Industry Applications

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of artificial intelligence (AI)-enabled versions of the GX series panel-mount type paperless recorders, GP series portable paperless recorders, and GA10 data logging software, which are components of the highly operable and expandable SMARTDAC+data acquisition and control system. This new AI functionality includes the future pen, a function developed by Yokogawa that enables the drawing of predicted waveforms. Yokogawa is also releasing a new CPU module for the e-RT3 Plus edge computing platform that is environmentally robust and Python compatible. The GX/GP and e-RT3 release is set for April 8, and the GA10 software will be released on May 13. The SMARTDAC+ system is a product in the OpreX Data Acquisition family, and the e-RT3 Plus is part of the OpreX Control Devices family.







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GCA relapse common in ustekinumab trial




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The sustained undermining of science by the EPA’s leaders is a travesty




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The software that powers scientific illustration




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The drivers of sustained use of liquified petroleum gas in India