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Former Arthrocare Executives Sentenced for Orchestrating $750 Million Securities Fraud Scheme

The former chief executive officer of ArthroCare Corporation was sentenced to serve 20 years in prison, and the former chief financial officer was sentenced to serve 10 years in prison today for their leading roles in a $750 million securities fraud scheme.



  • OPA Press Releases

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Trans Energy Inc. to Restore Streams and Wetland Damaged by Natural Gas Extraction Activities in West Virginia

The Department of Justice, the U.S. Environmental Protection Agency (EPA) and the West Virginia Department of Environmental Protection (WVDEP) today announced a settlement with Trans Energy Inc., requiring the oil and gas company to restore portions of streams and wetlands at 15 sites in West Virginia that were polluted by the company’s unauthorized discharge of dredge or fill material. Trans Energy will pay a penalty of $3 million to be divided equally between the federal government and the WVDEP. The Clean Water Act requires a company to obtain a permit from EPA and the U.S. Army Corps of Engineers prior to discharging dredge or fill material into wetlands, rivers, streams and other waters of the United States.



  • OPA Press Releases

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Two Companies to Pay $3.75 Million for Allegedly Causing Submission of Claims for Unreasonable or Unnecessary Rehabilitation Therapy at Skilled Nursing Facilities

Life Care Services LLC, a manager of skilled nursing facilities based in Des Moines, Iowa, and CoreCare V LLP, doing business as ParkVista, a skilled nursing facility in Fullerton, California, have agreed to pay a total of $3.75 million to the government for causing the submission of false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.



  • OPA Press Releases

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United States Pursues Claims Against Neurosurgeon, Spinal Implant Company, Physician-Owned Distributorships and Their Non-Physician Owners for Alleged Kickbacks and Medically Unnecessary Surgeries

The United States has filed two complaints under the False Claims Act against Michigan neurosurgeon Dr. Aria Sabit, spinal implant company Reliance Medical Systems, two Reliance distributorships—Apex Medical Technologies and Kronos Spinal Technologies—and the companies’ owners, Brett Berry, John Hoffman and Adam Pike.



  • OPA Press Releases

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Justice Department Files Fair Housing Lawsuit Against Kent State University for Discrimination Against Students with Disabilities in University Housing

The Justice Department today filed a lawsuit against the Kent State University, the Kent State University Board of Trustees and university officials for violating the Fair Housing Act by discriminating against students with disabilities in student housing.



  • OPA Press Releases

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Episcopal Ministries to the Aging Inc. to Pay $1.3 Million for Allegedly Causing Submission of Claims for Unreasonable or Unnecessary Rehabilitation Therapy at Skilled Nursing Facility

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.



  • OPA Press Releases

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U.S. Settlement with Michigan Utility to Reduce Emissions at Its Coal-Fired Power Plants, Fund Projects to Benefit Environment and Communities

In a settlement with the United States, Consumers Energy, a subsidiary of CMS Energy Corporation, has agreed to install pollution control technology, continue operating existing pollution controls and comply with emission rates to reduce harmful air pollution from the company’s five coal-fired power plants.



  • 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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Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud Conspiracies at Public Foreclosure Auctions

A Northern California real estate investor has agreed to plead guilty for his role in bid rigging and fraud conspiracies at public real estate foreclosure auctions in Northern California, the Department of Justice announced



  • OPA Press Releases

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Real Estate Investor Pleads Guilty to Bid Rigging and Fraud Conspiracies at Georgia Public Foreclosure Auctions

A Georgia real estate investor pleaded guilty today for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Fulton and DeKalb counties, Georgia



  • OPA Press Releases

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Executives of Swiss and Las Vegas Companies Convicted in International Investment Fraud Scheme

A federal jury in Las Vegas convicted two men of conspiracy, wire fraud and securities fraud yesterday for their roles in an approximately $10 million international investment fraud scheme involving numerous victims



  • OPA Press Releases

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Morgan Stanley Agrees to Pay $2.6 Billion Penalty in Connection with Its Sale of Residential Mortgage Backed Securities

The Justice Department today announced that Morgan Stanley will pay a $2



  • OPA Press Releases

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Junshi, Eli Lilly Agree To Co-develop JS016 Antibodies Against COVID-19

Junshi Biosciences, a China-based biopharmaceutical company, and Eli Lilly and Company (LLY) have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi SARS-CoV-2 Antibodies, or JS016, is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain. It is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science.




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Policy Priorities to Address Opioid Use Disorder

Individuals with opioid use disorder (OUD) struggle to get effective care: Of 2 million Americans with the illness, only 26% receive treatment. Now, as the coronavirus pandemic presents an added strain on the U.S. health care system, it is creating greater hardships for those seeking OUD treatment.




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How States and Counties Can Help Individuals With Opioid Use Disorder Re-Enter Communities

At least 95 percent of individuals in state prisons will eventually return to communities. In fact, in a typical year more than half a million people do so, with many more coming from jails. A disproportionate share of these individuals have one or more chronic illnesses.




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Care Coordination Strategies for Patients Can Improve Substance Use Disorder Outcomes

Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly...




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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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DSM Insight Series: 1 in 4 Consumers Prepare, Consume Breakfast in Less Than 5 Minutes

DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.




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Inaugural Healthy Women Health Economies Prize Announces Winning Research

A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award.




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APEC Economies Agree on Principles and Actions to Support Women in Science, Technology, Engineering, and Mathematics

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.




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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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Biodiversity Essential to APEC Economies

2020 APEC Science Prize Open for Nominations




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510(k) accessories

From : Communities>>Regulatory Open Forum
Hello, If there is a significant change to an accessory cleared under a 510(k) of a product, are we supposed to file a significant change to the FDA for the original 510(k) for the accessory? ------------------------------ Shikha Malik Regulatory Affairs Specialist II Dallas TX United States ------------------------------




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RE: 510(k) accessories

From : Communities>>Regulatory Open Forum
Hello Shikha, This depends on whether the form, function, and operation of the medical device is affected by the change to the accessory.  Without knowing the device, the accessory, or the type of change, it is hard to say, but I refer you to the FDA Guidance document for when to complete a 510(k) for an existing device.  If you go through the flowchart and read the descriptors for each there is the item B.5 and then the sub-boxes 1 through 4.  There is the question whether a change to accessory [More]




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MilliporeSigma set to build $100m facility for viral and gene therapies

The facility will be the companyâs second facility in Carlsbad specifically for its BioReliance viral and gene therapy service.




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AskBio buys BrainVectis for early-stage gene therapies

AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders.



  • Markets & Regulations

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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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Canada: A Haven for Internet Pharmacies and Organized Crime

Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) In 2005, the FDA launched an investigation into pharmaceuticals bought from “Canadian” internet pharmacies online and shipped to US consumers. Of 1700 packages these pharmacies supplied, fully 85 percent of those actually came from somewhere else, but 15 percent really came from Canada.  Worse, 32 of the drugs were found to be counterfeit.  All of these pacakges were ente [...]




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Trump Hasn’t Released Funds That Help Families of COVID-19 Victims Pay for Burials. Members of Congress Want to Change That.

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies.

“Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.”

ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead.

Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.”

In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday.

The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March.

On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures.

Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak.

The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million.

Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely.





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Supplies of some COVID-19 medicines to run out within days, government warns

Supplies of certain drugs used when intubating patients with COVID-19 will run out “over the coming days”, the government has warned.

To read the whole article click on the headline




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Pharmacies' dispensing increases by up to a third as a result of COVID-19, survey finds

Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association.

To read the whole article click on the headline




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Community pharmacies need £200m extra to stay afloat during COVID-19, trade body warns

Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned.

To read the whole article click on the headline




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Transcending boundaries: the role of pharmacists in gender identity services

There has been a surge in demand for gender identity services in the UK over the past five years. Although the current role of pharmacists is limited, their potential contribution within a multidisciplinary team supporting transgender patients is beginning to emerge.

To read the whole article click on the headline




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NHS England advises pharmacies to 'risk assess' BAME staff for susceptibility to COVID-19

NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background.

To read the whole article click on the headline




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Repairing spinal cord injuries with a protein that regulates axon regeneration

Temple University researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. They believe the discovery could be used to develop new treatments for both spinal cord and optic nerve injuries.




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Oberland Capital nabs $1.05B raise for late-stage plays, handing out cash for royalties

Come on in, the water’s warm. After billions already raised by VC firms since the advent of the pandemic for life science companies, Oberland Capital has tossed more than $1 billion into the pot.




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COVID-19: Lilly ramps up to beat the virus with neutralizing antibodies as scientists raise worries

Eli Lilly has teamed with China’s Junshi Biosciences in the U.S., marking the company's second COVID-19 pact to develop neutralizing antibodies against the virus. It promises to be a faster approach than designing a new small-molecule drug would be, but getting from idea to an effective product may not be so simple.




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Experts lay out post-pandemic retailing strategies

Marketing experts recommend that brands formulate a strategy to be as nimble as possible to deal with the as yet unknown changes to the supplement marketplace in the post pandemic world. A greater online capability is seen as one of key parts of that toolkit.




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Andy Serkis (and maybe Gollum?) will read 'The Hobbit' for coronavirus charities

Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday.




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Newsom unveils rules governing how quickly California communities can reopen businesses

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.




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Here are the Orange County communities with coronavirus cases

Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66.




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Most California counties fall short of reopening criteria as coronavirus cases climb

The vast majority of California isn't close to meeting Gov. Gavin Newsom's reopening requirements, a Times analysis finds.




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Here are the Orange County communities with coronavirus cases

Orange County continues to confirm more coronavirus cases. Here's the latest community breakdown.




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Who to tip and how much for doorstep deliveries during the COVID-19 pandemic

From cash and snacks to a verbal 'thank you,' there are options when it comes to showing your appreciation for delivery drivers.




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Newsom warns defiant counties they could lose coronavirus cash for reopening early

Gov. Gavin Newsom's administration sent letters to Modoc, Sutter and Yuba counties warning that the areas could be ineligible for disaster funding unless they adhere to the state's coronavirus reopening plan.




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Facebook and YouTube race to squash viral video full of coronavirus lies

The "Plandemic" video was the latest breakout hit from the coronavirus conspiracy theory industry. Social media companies are scrambling to ban it from their platforms.




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Roy Horn, dark-haired half of flamboyant illusionists Siegfried & Roy, dies of coronavirus-related complications

Roy Horn, the dark-haired half of Siegfried & Roy, raised the white tigers and other animals in the duo's extravagant shows that were one of the biggest draws on the Las Vegas Strip.




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Asia scans the world for best practices to reopen economies




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Japan names 518 companies subject to tighter foreign ownership rules




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Malaysia factories spring back to life for Japanese electronics