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COVID-19 medical trial to treat thousands with HIV, malaria drugs

A clinical study led by Melbourne’s Doherty Institute aims to treat every patient hospitalised with coronavirus infection over the next 18 months, in a bid to keep them out of intensive care.




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Coronavirus updates LIVE: Donald Trump to suspend immigration to US, Australian death toll stands at 74 as COVID-19 cases exceed 2.5 million worldwide

If you suspect you or a family member has coronavirus you should call (not visit) your GP or ring the national Coronavirus Health Information Hotline on 1800 020 080.




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Soundgarden members accuse Chris Cornell’s widow of withholding funds from 2019 benefit concert


The Seattle rock icons filed a countersuit Wednesday accusing Vicky Cornell of withholding money raised through a star-studded benefit concert held last year in the late singer’s honour, instead using it for personal purposes — an accusation Cornell denies.




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Sounds exhilarating

AWARD-WINNING musician and singer Vince Jones is among the top-notch jazz talent set to entertain audiences at the Tanks Arts Centre this year.




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YouTube expands fact-check panels in move against misinformation

San Francisco (AFP) April 28, 2020
YouTube on Tuesday began adding fact-check panels to search results in the US for videos on hot-topic claims shown to be bogus. The Google-owned video streaming service said it is expanding to the US a fact-check information panel feature launched last year in Brazil and India. Fact-check information panels highlight credible findings by third-parties so YouTube viewers can make informed




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Search team finds bodies of all Koreans missing in Himalayan avalanche

Kathmandu (AFP) May 1, 2020
A search team on Friday recovered the last remaining two bodies missing after a Himalayan avalanche in January buried four South Korean trekkers and three locals. A wall of snow hit the trekkers at about 3,200 metres (10,500 feet) near the Annapurna base camp in Nepal on January 17, covering them under metres of snow. Avalanches and more snowfall since then made it too dangerous to lau




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Friends star Lisa Kudrow shares rare photo of son Julian during family celebration

Lisa Kudrow is a doting mum to son Julian and has kept him out of the public eye during his...




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Watch as the Queen marks VE Day with moving speech from Windsor Castle 

Exactly 75 years after her father King George VI's historic broadcast marking the end...




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Chelsea's Pulisic sends message to Liverpool boss Klopp

The American international broke through at Borussia Dortmund when Klopp was still in charge, and was introduced to first-team training by the now Liverpool boss




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Coronavirus fears spark tourist ban at Tiwi Islands grand final

The Northern Territory's Tiwi Islands football grand final will go ahead tomorrow, but will be restricted to local spectators only because of coronavirus concerns, authorities say.




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NRL season continues for now, but Super Rugby suspends competition over coronavirus

NRL warns the coronavirus pandemic is rugby league's greatest ever challenge but games will continue for the moment, while Super Rugby announces it is suspending its season after this weekend.




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AFL cuts season to 17 rounds but delays call on suspending start of competition

The AFL reduces the men's competition to 17 rounds as it responds to the coronavirus pandemic, but it is yet to decide whether it will postpone the start of the season.




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Will football be suspended if a player catches COVID-19? It depends on the code

The AFL and NRL will both play matches this weekend, but both leagues are taking different approaches to dealing with the coronavirus outbreak.




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AFL delays decision on 2020 season opener as players demand 22 rounds

The AFL will decide on Wednesday whether the opening round of the men's season will go ahead this week, as the players push for a full home-and-away campaign of 22 matches instead of 17.




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'That's how we play the game': The essence and beauty of football on the Tiwi Islands

The game of footy is almost a different sport on the Northern Territory's Tiwi Islands — a place where former AFL star Austin Wonaeamirri says Aussie Rules is a way of life.




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AFL suspends season in response to coronavirus, but NRL opts to play on for now

The AFL calls a halt to games until at least May 31 in response to the coronavirus outbreak, but the NRL says it is proceeding until told to stop.




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Geelong coach Chris Scott defends AFL players amid pay cut negotiations

AFL players have been accused of being greedy and selfish during talks with the league over pay cuts now that the season is suspended, but the Cats coach says it is unfair.




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Steve Smith leadership ban ends quietly amid coronavirus limbo

Steve Smith is now free to captain Australia again if called upon, with the leadership ban arising from the ball-tampering scandal expiring quietly over the weekend.




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AFL boss confirms membership refunds after McGuire and Jones on-air clash

AFL chief executive Gillon McLachlan confirms club members can get their money back if they face financial hardship, but implores those who can afford it to stick with their clubs through the coronavirus pandemic.




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AFL to be played in 'very different landscape' after coronavirus pandemic

The coronavirus shutdown has already had a big impact on the AFL — but could the effects spill over into the way the game is played in future?




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Bridget McKenzie breaks her silence, defends handling of sports grants

Former Cabinet minister Bridget McKenzie defends her actions in the sports grants scandal, saying it was her "responsibility" to exercise discretion and allocate grants to projects that had not been merit-listed.




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Unwell Warriors player stays home as team lands in Australia

The New Zealand Warriors, minus two players, touch down in Australia on a charter flight from Auckland to prepare for the resumption of the NRL season.




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With Met Gala postponed, James Corden finds high fashion on furry friends

The coronavirus crisis upended the star-studded Met Gala, so late-night TV host James Corden put on the Pet Gala. Yes, it was as cute as it sounds.




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His Ahmaud Arbery portrait went viral. How an L.A. artist finds power in art

Artivist Nikkolas Smith combines personal storytelling with issues of national significance in his work.




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Navy recommends reinstatement of fired carrier captain

Officials say the top Navy officer has recommended the reinstatement of the aircraft carrier captain fired for sending an email pleading for faster action to protect his crew from a coronavirus outbreak.




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Coronavirus leaves Washington farmers with a big problem: What do you do with a billion pounds of potatoes?

Washington state has a billion pounds of potatoes -- with no destination




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Coronavirus: Pandemic sends US jobless rate to 14.7%

US unemployment rises to its highest level since the 1930s as coronavirus devastates the economy.




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Coronavirus: Inclusive choir finds voice in lockdown

The Soundabout Inclusive Choir is helping to overcome the isolation felt by some people with special needs.




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Coronavirus: Fairgrounds packed up with nowhere to go

Britain's showmen are facing financial ruin as lockdown means fairgrounds rusting away in storage.




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Tekashi69 Sounds Off In Live Stream, Sets Records With Epic Rant

Tekashi just streamed from in-home incarceration, setting an Instagram Live record with 2 million people tuning in. 6ix9ine trolled off the bat, bumping "Bad Boys" while toying with a pair of handcuffs. Tekashi got a lot off his plate ... admitting…




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Blackline Systems Lands $146,000,000 New Financing Round

BlackLine (NASDAQ: BL) is the worlds most trusted solution for Finance Controls & Automation for delivering powerful real-time automation to accounting & finance teams.




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GovX Lands $3,728,482 New Funding Round

The largest Military & Government exclusive ecommerce site offering discounts up to 50% off current season goods from 250+ top lifestyle and tactical brands.




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4 Tech Trends for the New Hotel Age

For businesses serving the hospitality sector, growth relies on implementing and capitalizing modernized systems to improve processes and increase guest satisfaction. These are the four most important strategies to achieve this goal in 2020.

Keep on reading: 4 Tech Trends for the New Hotel Age




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FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.




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DCGI extends validity of registration of BA/BE study centres




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Pallone and Neal Demand Transparency into Methodology and Distribution of COVID-19 Health Care Provider Relief Funds

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ways and Means Chairman Richard E. Neal (D-MA) sent a letter to Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma today raising a series of concerns over the methodology used to distribute and the lack of transparency into how COVID-19 relief funds and loans for health care providers are being spent.  “We write to raise serious concerns about the Provider Relief Fund and the Accelerated and Advance Payment Programs,” Pallone and Neal wrote.  “With respect to each, we are concerned about the lack of transparency with Congress and the American people about how funds are being spent or loans are being made.  We also have grave concerns regarding the methodology being used to distribute $175 billion Congress appropriated for the Provider Relief Fund.” The Chairmen’s letter documents concerns with how the programs are being run, in particular the Administration’s methodologies for distributing funding that has shortchanged a number of critical providers and makes clear that more transparency is needed for Congress to accurately assess the ongoing needs of health care providers as the COVID-19 crisis unfolds. “The Administration’s efforts to establish the Provider Relief Fund to date has been at best, a series of missteps, and at worst, a disregard of Congress’ intent for the program,” Pallone and Neal continued in their letter. Pallone and Neal wrote that when Congress passed the CARES Act, it was clear that the funding provided to HHS for the Provider Relief Fund was for the express purpose, “to prevent, prepare for, and respond to coronavirus.”  The two Chairs voiced concern that some of the funding formulas adopted to date fail to target funding based on the statutory framework relating to COVID-19 driven costs.  In fact, the Chairs write that the level of funding appears to be, “completely disconnected from need.” The Chairmen requested an immediate response from HHS regarding documents and information pertaining to the Provider Relief Fund and the Accelerated and Advanced Payment Program.  Pallone and Neal also wrote that if HHS is unable to immediately provide the information, it should provide a timeline of when the Committees would receive the requested information. While recognizing the incredible demands on the Department at this difficult time, the Chairmen emphasized that, “This crisis demands that we work swiftly and based on the best data available.  Currently, despite repeated requests, this Administration has prevented Congress from obtaining the data that the Department has available on funding for our health care system, data that is necessary to inform near future legislation.  We look forward to receiving this information so that we can conduct the business the American people expect of us.  We look forward to having you join us at the earliest possible date in each of our Committees to discuss these and other COVID-related issues.” To read the full letter, click HERE. ###




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Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO

Trovagene (NASDAQ: TROV), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational […]




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GSK hire Jonathan Symonds as new Chairman

Business chief Jonathan Symonds has joined British multinational GlaxoSmithKline as the company’s new non-executive chairman.

The hire ends GSK’s six month search, as it prepares to fold its consumer business into a joint venture with Pfizer. In his new role Symonds will oversee the changes being implemented by CEO Emma Walmsley who joined GSK in 2017. Walmsley hopes to revitalise GSK’s R&D efforts with the help of Chief Scientific Officer Hal Barron.

read more




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ThoughtSphere lands patent for clinical trial data technology

The data management solution is designed to help sponsors and CROs manage data more effectively, increasing cost efficiency and effectiveness.




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Elsevier: Challenges and Trends to Watch in 2020 (Guest Post)

Today’s guest post comes from Trygve Anderson, Vice President of Commercial Pharmacy at Elsevier.

Trygve discusses trends and challenges to watch in 2020, including drug pricing transparency, the approval and interchangeability of biosimilars, and stakeholder access to timely and accurate data.

Learn more about Elsevier’s information analytics capabilities from its video: Evaluating Drug Data Yields Business Value.

Read on for Trygve’s insights.
Read more »
        




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Majority of Americans Open to Clinical Trial Participation If Recommended by a Doctor, New Study Finds

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials....




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ACRO expands membership with addition of three digital technology companies

The Association of Clinical Research Organizations (ACRO) is pleased to announce the expansion of its membership to include ERT, Oracle and Veeva. These new ACRO member companies, with their focus on digital technologies that enable global clinical trials, characterize the ongoing innovation and evolution of contemporary clinical research. ACRO now has 12 member companies.




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European Medicines Agency’s review of Picato finds its risks outweigh its benefits

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.




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BRIEF—GSK completes sale of nutrition brands for £3.4 billion

GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products…



  • Companies
  • mergers and acquisitions/Deals/Financial/GlaxoSmithKline/India/Pharmaceutical/UK

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Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT

Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports.




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Two Plead Guilty to Conspiracy to File False Claims for Tax Refunds

Odell Folks, a resident of Brooklyn, N.Y., and Tanya Smith, a resident of Waterbury, Conn., pleaded guilty to conspiracy to file false claims for tax refunds. Folks also pleaded guilty to mail fraud and making a false tax return.



  • OPA Press Releases

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New York Woman Pleads Guilty to Conspiracy to File False Claims for Tax Refunds

A woman from the Bronx, N.Y., pleaded guilty today to conspiracy to making false claims and mail fraud. The indictment alleged that between approximately May 1, 2003, and Feb. 28, 2005, Sharon Smith and others participated in a scheme to file false and fraudulent individual income tax returns in the names of individuals who were not entitled to the refunds that were claimed.



  • 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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Antitrust Division Announces Initiative to Help Protect Recovery Funds from Fraud, Waste and Abuse

The Department's Antitrust Division announced the details of its newly formed initiative aimed at preparing government officials and contractors to recognize and report efforts by parties to unlawfully profit from the stimulus projects that are being awarded as part of The American Recovery and Reinvestment Act of 2009.    



  • OPA Press Releases

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Federal Judge Hands Downs Sentences in Holy Land Foundation Case

Today, in federal court in Dallas, U.S. District Judge Jorge A. Solis sentenced the Holy Land Foundation for Relief and Development (HLF) and five of its leaders following their convictions by a federal jury in November 2008 on charges of providing material support to Hamas, a designated foreign terrorist organization.



  • OPA Press Releases