tal A $100 Million Biotech Deal Is Also A Tale Of Two Executives Facing Their Kids’ Deadly Diseases By www.forbes.com Published On :: Thu, 20 Sep 2018 10:00:00 +0000 “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.” Full Article ticker=NASDAQ:FOLD ticker=NYSE:SNY byline=Matthew Herper
tal Paralyzed Patients Go From Wheelchairs To Walkers With Experimental Treatment By www.forbes.com Published On :: Mon, 24 Sep 2018 15:02:00 +0000 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. Full Article ticker=NYSE:MDT byline=Matthew Herper
tal Novartis acquires digital therapeutics specialist Amblyotech By www.outsourcing-pharma.com Published On :: Tue, 28 Apr 2020 15:39:00 +0100 The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders. Full Article Markets & Regulations
tal British MP Benn talks Brexit challenges and the future of UK clinical research industry By www.acrohealth.org Published On :: Wed, 18 Apr 2018 15:32:25 +0000 The Association of Clinical Research Organizations (ACRO) highlights contributions to health and economy (Leeds, UK) – Facing unprecedented challenges associated with Brexit,... Full Article News Press Releases Brexit MP UK
tal ACRO Opposes Fatally-Flawed Right-To-Try Legislation By www.acrohealth.org Published On :: Fri, 18 May 2018 23:01:22 +0000 In May of 2017 the Board of Directors of the Association of Clinical Research Organizations, which represents the world’s leading clinical research... Full Article News Press Releases Compassionate Use Congress House Right-To-Try Senate
tal Who’s in and who’s out? ACRO talks Inclusion-Exclusion Criteria By www.acrohealth.org Published On :: Tue, 29 May 2018 19:10:10 +0000 ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers Clinical trials have an enormous number of inter-related,... Full Article News Duke University FDA recruitment
tal ACRO members talk UK competitiveness and enabling post-Brexit success By www.acrohealth.org Published On :: Thu, 19 Jul 2018 03:14:35 +0000 What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto... Full Article News Brexit UK
tal EU efforts turn towards digital for 2019 By www.acrohealth.org Published On :: Wed, 27 Feb 2019 23:46:11 +0000 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. Full Article News Clinical Trial Regulation digital EU
tal ACRO expands membership with addition of three digital technology companies By www.acrohealth.org Published On :: Mon, 15 Apr 2019 15:54:16 +0000 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. Full Article News Press Releases ERT IQVIA membership Oracle Veeva
tal Remdesivir: early findings on experimental coronavirus drug offer 'quite good news' By www.theguardian.com Published On :: 2020-04-29T21:58:54Z Preliminary results of US government trial show patients who received drug recovered faster than othersHopes 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... Full Article Coronavirus outbreak Pharmaceuticals industry US news Infectious diseases Science Medical research World news
tal Remdesivir: five Australian hospitals to receive experimental coronavirus drug By www.theguardian.com Published On :: 2020-05-01T00:31:31Z Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?Sign up for Guardian Australia’s daily coronavirus emailDownload the free Guardian app to get the most important news notificationsThe 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... Full Article Health Coronavirus outbreak Australia news Infectious diseases Sydney Medical research Pharmaceuticals industry
tal Italy to relax COVID-19 lockdown in early May By www.pharmafile.com Published On :: Mon, 27 Apr 2020 11:35:23 +0000 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. Full Article coronavirus COVID-19 COVID-19 coronavirus Italy Sales and Marketing
tal 12 British children hospitalised with rare condition linked to COVID-19 By www.pharmafile.com Published On :: Tue, 28 Apr 2020 09:25:30 +0000 12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19. Full Article coronavirus COVID-19 NHS NHS UK Manufacturing and Production
tal Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients By www.pharmafile.com Published On :: Thu, 30 Apr 2020 10:12:25 +0000 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. Full Article coronavirus COVID-19 Gilead remdesivir Research and Development
tal UK testing experimental treatment for use in COVID-19 patients By www.pharmafile.com Published On :: Mon, 04 May 2020 10:06:21 +0000 British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus. Full Article coronavirus coronavirus treatment COVID-19 Sales and Marketing
tal FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients By www.pharmafile.com Published On :: Mon, 04 May 2020 11:31:55 +0000 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. Full Article coronavirus COVID-19 FDA Gilead remdesivir Sales and Marketing
tal Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner By www.fiercepharma.com Published On :: Fri, 01 May 2020 14:30:25 +0000 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. Full Article
tal Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says By www.fiercepharma.com Published On :: Tue, 05 May 2020 19:56:27 +0000 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. Full Article
tal FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact By www.fiercepharma.com Published On :: Fri, 08 May 2020 10:10:53 +0000 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. Full Article
tal Singapore reports 753 new coronavirus cases, taking total to 22,460 By feeds.reuters.com Published On :: Sat, 09 May 2020 03:27:35 -0400 Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases. Full Article healthNews
tal Tijuana coronavirus death rate soars after hospital outbreaks By feeds.reuters.com Published On :: Sat, 09 May 2020 07:16:27 -0400 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. Full Article healthNews
tal Justice Department Settles Lawsuit Alleging Gender Discrimination and Retaliation by the Puerto Rico Police Department By www.justice.gov Published On :: Fri, 30 Jan 2009 12:40:59 EST 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. Full Article OPA Press Releases
tal Three Former Atlanta Police Officers Sentenced to Prison in Fatal Shooting of Elderly Atlanta Woman By www.justice.gov Published On :: Tue, 24 Feb 2009 17:28:52 EST 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. Full Article OPA Press Releases
tal N.J. Electrical Company Employee Pleads Guilty to Defrauding the Environmental Protection Agency at Superfund Site By www.justice.gov Published On :: Thu, 26 Feb 2009 12:31:51 EST 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. Full Article OPA Press Releases
tal Justice Department Sues Harrison County, Ind., Sheriff for Sexual Harassment and Retaliation By www.justice.gov Published On :: Thu, 5 Mar 2009 11:56:29 EST 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. Full Article OPA Press Releases
tal United States Joins Suit Against Community Health Systems Inc. and Three of Its Hospitals in New Mexico By www.justice.gov Published On :: Fri, 6 Mar 2009 16:10:04 EST 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. Full Article OPA Press Releases
tal Shipping Line Pays $1.4 Million for Environmental Crimes By www.justice.gov Published On :: Tue, 10 Mar 2009 18:22:58 EDT 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. Full Article OPA Press Releases
tal General Maritime Management (Portugal) Fined $1 Million for Enviromental Crimes By www.justice.gov Published On :: Mon, 16 Mar 2009 12:43:01 EDT 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 worlds oceans as required by United States and international law. Full Article OPA Press Releases
tal Houstons Methodist Hospital to Pay U.S. More Than $9 Million to Resolve Allegations of Overcharging Medicare By www.justice.gov Published On :: Thu, 26 Mar 2009 11:43:10 EDT 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. Full Article OPA Press Releases
tal Connecticut Resident Pleads Guilty to Multi-Million Dollar Tax Fraud Conspiracy Involving New York City Hospital By www.justice.gov Published On :: Thu, 2 Apr 2009 16:51:28 EDT 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. Full Article OPA Press Releases
tal United States Announces Largest Settlement Under Environmental Protection Agencys Audit Policy By www.justice.gov Published On :: Mon, 13 Apr 2009 13:59:45 EDT 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. Full Article OPA Press Releases
tal Oil Company and Two Executives Plead Guilty to Environmental Crimes By www.justice.gov Published On :: Thu, 16 Apr 2009 17:29:40 EDT 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. Full Article OPA Press Releases
tal Cast Iron Pipe Manufacturer Sentenced for Environmental Crimes and Worker Safety Violations By www.justice.gov Published On :: Mon, 27 Apr 2009 11:00:09 EDT 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. Full Article OPA Press Releases
tal Justice Department Seeks to Bar New York Attorney from Using Employment Taxes as Working Capital By www.justice.gov Published On :: Thu, 7 May 2009 14:51:19 EDT 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. Pruzans 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. Full Article OPA Press Releases
tal Deputy Attorney General David W. Ogden at His Installation Ceremony By www.justice.gov Published On :: Fri, 8 May 2009 17:30:44 EDT "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." Full Article Speech
tal Alaska Mine Operators to Pay $883,628 to Resolve Environmental Violations By www.justice.gov Published On :: Tue, 12 May 2009 14:32:04 EDT 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. Full Article OPA Press Releases
tal Minnesota Hospitals to Pay U.S. $2.28 Million to Settle False Claims Act Allegations By www.justice.gov Published On :: Thu, 21 May 2009 10:45:59 EDT 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. Full Article OPA Press Releases
tal New Jersey University Hospital to Pay Additional $2 Million to Resolve Fraud Claims That Facility Double Billed Medicaid By www.justice.gov Published On :: Tue, 9 Jun 2009 14:22:32 EDT 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, UMDNJs University Hospital submitted claims to Medicaid for outpatient physician services that were also being billed by doctors working in the hospitals outpatient centers. Full Article OPA Press Releases
tal Owner of New Jersey Landscaping Sub-Contractor Pleads Guilty to Defrauding the Environmental Protection Agency By www.justice.gov Published On :: Thu, 25 Jun 2009 12:52:36 EDT 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. Full Article OPA Press Releases
tal Justice Department Files Complaint and Reaches Settlement to Improve Conditions at Texas State Facilities for Persons with Developmental Disabilities By www.justice.gov Published On :: Fri, 26 Jun 2009 13:42:15 EDT The Department announced a simultaneous lawsuit and settlement with the state of Texas concerning the care given to residents of the states 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 states compliance with the settlement agreement and the court will retain ultimate jurisdiction. Full Article OPA Press Releases
tal Canadian Executive Pleads Guilty to Fraud and Money Laundering Conspiracies Involving a New Jersey Environmental Protection Agency Superfund Site By www.justice.gov Published On :: Mon, 6 Jul 2009 13:43:54 EDT 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. Full Article OPA Press Releases
tal Federal Corrections Officer Convicted of Civil Rights Charges Related to Fatal Assault By www.justice.gov Published On :: Wed, 29 Jul 2009 19:42:49 EDT 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. Full Article OPA Press Releases
tal Two Chemical Companies Agree to Resolve Environmental Violations in Ohio By www.justice.gov Published On :: Fri, 31 Jul 2009 16:44:23 EDT 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. Full Article OPA Press Releases
tal Five Companies Agree to $21 Million Settlement for Environmental Damages in Pennsylvania By www.justice.gov Published On :: Mon, 3 Aug 2009 13:48:20 EDT 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. Full Article OPA Press Releases
tal Four Puerto Rico Police Officers Convicted of Federal Civil Rights Charges Related to Fatal Assault By www.justice.gov Published On :: Thu, 13 Aug 2009 17:29:17 EDT 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. Full Article OPA Press Releases
tal Two Chief Engineers from Oil Tanker “Georgios M” Indicted for Environmental Crimes By www.justice.gov Published On :: Thu, 20 Aug 2009 17:25:36 EDT 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. Full Article OPA Press Releases
tal Vice President of Missouri Pesticide Company Pleads Guilty to Environmental Crimes By www.justice.gov Published On :: Mon, 31 Aug 2009 14:10:54 EDT 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. Full Article OPA Press Releases
tal President of Missouri Pesticide Company Sentenced for Environmental Crimes By www.justice.gov Published On :: Tue, 1 Sep 2009 18:16:32 EDT 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. Full Article OPA Press Releases
tal Department of Justice Will Not Challenge Hospitals’ Joint Purchasing Agreement By www.justice.gov Published On :: Fri, 4 Sep 2009 12:42:47 EDT 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. Full Article OPA Press Releases
tal Three Individuals Indicted for Roles in Conspiracy Schemes Involving Two U.S. Environmental Protection Agency Superfund Sites in New Jersey By www.justice.gov Published On :: Fri, 11 Sep 2009 14:50:54 EDT 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. Full Article OPA Press Releases