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A $100 Million Biotech Deal Is Also A Tale Of Two Executives Facing Their Kids’ Deadly Diseases

“John, I’m very aware of your family’s journey, Twelve years ago I was one of the producers considering bidding on your life rights.”




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Paralyzed Patients Go From Wheelchairs To Walkers With Experimental Treatment

Two different groups of researchers have shown that electrical stimulation of the spinal cord, combined with months of intense training, can allow some people who have been paralyzed to regain some walking ability.




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Novartis acquires digital therapeutics specialist Amblyotech

The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders.



  • Markets & Regulations

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British MP Benn talks Brexit challenges and the future of UK clinical research industry

The Association of Clinical Research Organizations (ACRO) highlights contributions to health and economy (Leeds, UK) – Facing unprecedented challenges associated with Brexit,...




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ACRO Opposes Fatally-Flawed Right-To-Try Legislation

In May of 2017 the Board of Directors of the Association of Clinical Research Organizations, which represents the world’s leading clinical research...




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Who’s in and who’s out? ACRO talks Inclusion-Exclusion Criteria

ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers Clinical trials have an enormous number of inter-related,...




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ACRO members talk UK competitiveness and enabling post-Brexit success

What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto...




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EU efforts turn towards digital for 2019

2018 was a busy and productive year for ACRO’s European Scientific & Regulatory Committee, which meets quarterly in London. While the Committee focused largely on the continuing implementation of the EU Clinical Trial Regulation, there were also opportunities to engage with regulators on other topics ranging from European regulatory strategy to Advanced Therapies to the urgent challenges of Brexit.




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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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Remdesivir: early findings on experimental coronavirus drug offer 'quite good news'

Preliminary results of US government trial show patients who received drug recovered faster than others

Hopes of an effective drug treatment for coronavirus patients have risen following positive early results from a trial of remdesivir, a drug first tried in Ebola patients.

Data from the trial on more than 1,000 severely ill patients in 75 hospitals around the world show that patients put on the drug recovered 31% faster than similar patients who were given a placebo drug instead. Remdesivir cut recovery time from a median of 15 days to 11.

Related: World's stock markets soar on coronavirus treatment hopes

Continue reading...




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Remdesivir: five Australian hospitals to receive experimental coronavirus drug

Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead

The US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.

The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”.

Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

Continue reading...




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Italy to relax COVID-19 lockdown in early May

Italy has outlined its plans to ease the lockdown restrictions that were implemented across the country 7 weeks ago to combat the COVID-19 coronavirus pandemic.




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12 British children hospitalised with rare condition linked to COVID-19

12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19.




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Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.




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UK testing experimental treatment for use in COVID-19 patients

British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.




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FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.




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Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 




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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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FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.




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Singapore reports 753 new coronavirus cases, taking total to 22,460

Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases.




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Tijuana coronavirus death rate soars after hospital outbreaks

The number of deaths from the coronavirus in Mexico's best-known border city, Tijuana, has soared and the COVID-19 mortality rate is twice the national average, the health ministry says, after medical staff quickly fell ill as the outbreak rampaged through hospital wards.




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Justice Department Settles Lawsuit Alleging Gender Discrimination and Retaliation by the Puerto Rico Police Department

The Department today announced that it has reached a consent decree with the Policía de Puerto Rico (Puerto Rico Police Department or PRPD) that will, if approved by the federal district court, resolve a complaint the Department filed in March 2008 alleging that the PRPD engaged in unlawful employment discrimination based on gender and retaliation, in violation of Title VII of the Civil Rights Act. Title VII prohibits employment discrimination on the basis of race, color, sex, national origin and religion, and also prohibits retaliation against persons for filing charges of discrimination.



  • OPA Press Releases

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Three Former Atlanta Police Officers Sentenced to Prison in Fatal Shooting of Elderly Atlanta Woman

Three former Atlanta Police Department (APD) officers were sentenced to prison today by Chief U.S. District Judge Julie E. Carnes on a charge of conspiracy to violate civil rights resulting in death, arising from the fatal police shooting of Kathryn Johnston, a 92-year old Atlanta woman.



  • OPA Press Releases

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N.J. Electrical Company Employee Pleads Guilty to Defrauding the Environmental Protection Agency at Superfund Site

An employee of a Sewell, N.J., company that provided temporary electrical utilities pleaded guilty today to participating in a fraud conspiracy at an Environmental Protection Agency (EPA)-designated Superfund site in New Jersey.



  • OPA Press Releases

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Justice Department Sues Harrison County, Ind., Sheriff for Sexual Harassment and Retaliation

The Department filed a lawsuit against Harrison County Sheriff George Michael Deatrick, in his official capacity, alleging that he discriminated against current employee Deana Decker and former employee Melissa Graham, in the form of sexual harassment that resulted in a hostile work environment, and retaliation, in violation of Title VII of the Civil Rights Act of 1964.



  • OPA Press Releases

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United States Joins Suit Against Community Health Systems Inc. and Three of Its Hospitals in New Mexico

The United States has intervened in a whistleblower suit filed in the District of New Mexico against Community Health Systems Inc. (CHS) and three of its hospitals in New Mexico: Eastern New Mexico Medical Center in Roswell, Mimbres Memorial Hospital in Deming, and Alta Vista Regional Hospital in Las Vegas. The suit alleges that CHS and its three hospitals violated the False Claims Act (FCA) by knowingly causing to be presented to the United States false claims for federal matching Medicaid funds.



  • OPA Press Releases

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Shipping Line Pays $1.4 Million for Environmental Crimes

Holy House Shipping AB, a Swedish corporation, was sentenced today in U.S. District Court in Camden, N.J., to pay a $1 million fine, a special assessment of $400,000 in community service payments and serve three years of probation for failing to maintain an accurate oil record book in an attempt to conceal illegal discharges of oil-contaminated waste directly into the ocean from one of its ships.



  • OPA Press Releases

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General Maritime Management (Portugal) Fined $1 Million for Enviromental Crimes

A federal judge in Corpus Christi, Texas, has sentenced General Maritime Management (Portugal), the operator of a fleet of tanker vessels, and two crewmembers of the motor tanker Genmar Defiance for making false statements to the U.S. Coast Guard and failing to maintain an accurate Oil Record Book designed to prevent pollution of the world’s oceans as required by United States and international law.



  • OPA Press Releases

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Houston’s Methodist Hospital to Pay U.S. More Than $9 Million to Resolve Allegations of Overcharging Medicare

Methodist Hospital in Houston has agreed to pay the United States $9.99 million to settle allegations that it defrauded the federal Medicare program. The settlement resolves allegations that Methodist improperly increased charges to Medicare patients in order to obtain enhanced reimbursement from Medicare.



  • OPA Press Releases

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Connecticut Resident Pleads Guilty to Multi-Million Dollar Tax Fraud Conspiracy Involving New York City Hospital

A Trumbull, Conn., resident who was involved in operating three businesses in Brooklyn, N.Y., pleaded guilty to conspiring to defraud the Internal Revenue Service (IRS). Krzysztof Koczon pleaded guilty in U.S. District Court in Manhattan to conspiracy to aid another in filing false tax returns.



  • OPA Press Releases

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United States Announces Largest Settlement Under Environmental Protection Agency’s Audit Policy

Invista will pay a $1.7 million civil penalty and spend up to an estimated $500 million to correct self-reported environmental violations discovered at facilities in seven states. The company disclosed more than 680 violations of water, air, hazardous waste, emergency planning and preparedness, and pesticide regulations to EPA after auditing 12 facilities it acquired from DuPont in 2004.



  • OPA Press Releases

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Oil Company and Two Executives Plead Guilty to Environmental Crimes

Texas Oil and Gathering Inc., its owner John Kessel and its operations manager Edgar Pettijohn pleaded guilty today in U.S. District Court in Houston to criminal violations related to the disposal of refinery wastes at an underground injection well in violation of the Safe Drinking Water Act.



  • OPA Press Releases

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Cast Iron Pipe Manufacturer Sentenced for Environmental Crimes and Worker Safety Violations

Atlantic States Cast Iron Pipe Co. a Phillipsburg, N.J.-based division of McWane Inc. of Alabama was sentenced today to pay a fine of $8 million for violations of environmental and worker safety laws as well as obstructing the federal investigation of its conduct.



  • OPA Press Releases

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Justice Department Seeks to Bar New York Attorney from Using Employment Taxes as Working Capital

The United States has filed a lawsuit against New York attorney Thomas B. Pruzan, d/b/a the Pruzan Law Firm, seeking to put an end to Mr. Pruzan’s repeated failure to timely deposit and pay the employment and unemployment taxes due from his law firm, as well as his failure to timely file employment and unemployment tax returns with the Internal Revenue Service.



  • OPA Press Releases

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Deputy Attorney General David W. Ogden at His Installation Ceremony

"This is an exciting time as well as a challenging one, and under the leadership of this President and this Attorney General, we are up for the job together."




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Alaska Mine Operators to Pay $883,628 to Resolve Environmental Violations

Alaska Gold Co. (Alaska Gold), and NovaGold Resources Inc. (NovaGold), the owners and operators of the Rock Creek Mine near Nome, Alaska, have agreed to pay a $883,628 civil penalty to resolve violations of a storm water discharge permit.



  • OPA Press Releases

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Minnesota Hospitals to Pay U.S. $2.28 Million to Settle False Claims Act Allegations

Three HealthEast Care System hospitals have agreed to pay the United States $2.28 million to settle allegations that the health care facilities submitted false claims to Medicare. All three hospitals are located in the Minneapolis-St. Paul, Minn., area. The settlement resolves allegations that the St. Paul-based hospitals overcharged Medicare from 2002 to 2007 by thousands of dollars each time they performed kyphoplasty, a minimally-invasive procedure used to treat certain spinal fractures that often are due to osteoporosis.



  • OPA Press Releases

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New Jersey University Hospital to Pay Additional $2 Million to Resolve Fraud Claims That Facility Double Billed Medicaid

The University of Medicine and Dentistry of New Jersey (UMDNJ) has agreed to pay the United States $2 million to resolve federal civil fraud allegations that its hospital defrauded Medicaid. From 1993 to 2004, UMDNJ’s University Hospital submitted claims to Medicaid for outpatient physician services that were also being billed by doctors working in the hospital’s outpatient centers.



  • OPA Press Releases

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Owner of New Jersey Landscaping Sub-Contractor Pleads Guilty to Defrauding the Environmental Protection Agency

The co-owner of a Martinsville, N.J., landscaping company pleaded guilty to participating in a fraud conspiracy at the Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J. Frederick Landgraber pleaded guilty in the U.S. District Court of New Jersey today to one count of conspiracy to defraud the EPA from approximately March 2002 until approximately June 2005 at the Federal Creosote site.



  • OPA Press Releases

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Justice Department Files Complaint and Reaches Settlement to Improve Conditions at Texas State Facilities for Persons with Developmental Disabilities

The Department announced a simultaneous lawsuit and settlement with the state of Texas concerning the care given to residents of the state’s 13 facilities for persons with developmental disabilities. Along with the settlement agreement, the Department will file a complaint initiating a lawsuit against the state in federal court. An independent monitor will be appointed to oversee the state’s compliance with the settlement agreement and the court will retain ultimate jurisdiction.



  • OPA Press Releases

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Canadian Executive Pleads Guilty to Fraud and Money Laundering Conspiracies Involving a New Jersey Environmental Protection Agency Superfund Site

A former executive of Bennett Environmental Inc. (BEI), a Canadian-based company that treats and disposes of contaminated soil, pleaded guilty to participating in a conspiracy to pay kickbacks and commit fraud at the U.S. Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J. The former executive also pleaded guilty to participating in a money laundering conspiracy and impeding a proceeding before the U.S. Securities and Exchange Commission.



  • OPA Press Releases

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Federal Corrections Officer Convicted of Civil Rights Charges Related to Fatal Assault

A federal jury in Orlando, Fla, found Erin Sharma, a Bureau of Prisons corrections officer, guilty today on felony federal civil rights charges related to a fatal assault on an inmate in March 2005.



  • OPA Press Releases

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Two Chemical Companies Agree to Resolve Environmental Violations in Ohio

The former and current owners and operators of a chemical facility in Addyston, Ohio, LANXESS Corp. and INEOS ABS USA Corp., have agreed to pay a $3.1 million civil penalty and INEOS will spend up to $2 million to install environmental controls and modify operating procedures to resolve violations of multiple environmental laws.



  • OPA Press Releases

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Five Companies Agree to $21 Million Settlement for Environmental Damages in Pennsylvania

Five companies have agreed to compensate the United States and the Commonwealth of Pennsylvania nearly $21.4 million in cash and valuable property to address natural resource damages resulting from decades of zinc smelting operations at the Palmerton Zinc Pile Superfund site in northeast Pennsylvania.



  • OPA Press Releases

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Four Puerto Rico Police Officers Convicted of Federal Civil Rights Charges Related to Fatal Assault

A federal jury in San Juan, Puerto Rico, found four San Juan Municipal Police Officers guilty today of felony federal civil rights charges related to the fatal beating of Jose Antonio Rivera Robles.



  • OPA Press Releases

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Two Chief Engineers from Oil Tanker “Georgios M” Indicted for Environmental Crimes

A federal grand jury in Houston has returned an indictment charging two crewmembers of the oil tanker Georgios M with making false statements, violating federal law designed to prevent pollution from ships and obstruction of justice.



  • OPA Press Releases

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Vice President of Missouri Pesticide Company Pleads Guilty to Environmental Crimes

The vice president of a Missouri pesticide company, HPI Products Inc., pleaded guilty today in federal court in Kansas City, Mo., for violating a federal pesticides law designed to provide proper regulatory oversight and prevent improper storage of pesticides.



  • OPA Press Releases

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President of Missouri Pesticide Company Sentenced for Environmental Crimes

William Garvey, the president of HPI Products Inc., a pesticide company based in St. Joseph, Mo., was sentenced today in federal court in Kansas City, Mo., for violations of the Clean Water Act and hazardous waste storage laws related to the company’s pesticide production.



  • OPA Press Releases

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Department of Justice Will Not Challenge Hospitals’ Joint Purchasing Agreement

The Department will not challenge a proposal by Memorial Health Inc. (Memorial), and St. Joseph’s/Candler Health System (St. Joseph’s/Candler) to enter an exclusive joint purchasing agreement with respect to the purchase of certain medical and surgical supplies.



  • OPA Press Releases

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Three Individuals Indicted for Roles in Conspiracy Schemes Involving Two U.S. Environmental Protection Agency Superfund Sites in New Jersey

A Newark grand jury indicted three individuals for their participation in fraud and kickback conspiracies related to contracts at a U.S. Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J.



  • OPA Press Releases