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

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

The Association of Clinical Research Organizations (ACRO) convenes discussion series that seeks to advance an industry with important health and economic impacts...

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.

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

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

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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?

English excess deaths from the coronavirus are comparable to the worst hit countries in Europe, according to a Sky News analysis.

Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.

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

Alexion has announced it is to acquire Boston-based blood disorder specialist Portola Pharmaceuticals in a transaction to the value of $1.41 billion in cash.

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.

Shares of Danish allergy immunotherapy specialist ALK Abello were up almost 10% at 1,788.00 Danish kroner…

Following a couple of active M&A years, USA-based Alexion Pharmaceuticals has now reached a definitive…

US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…

Israel-based Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2020,…

US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,…

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…

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. 

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.

Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.

Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year.

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion.

Roy Lynn Oakley, 67, a resident of Harriman, Tenn., pleaded guilty today in U.S. District Court in Knoxville, to count one of an indictment charging him with unlawful disclosure of Restricted Data under the Atomic Energy Act, in violation of 42 U.S.C., Section 2274(b).

Hassan Saied Keshari and his corporation, Kesh Air International, pleaded guilty this morning in the Southern District of Florida to charges of conspiring to illegally export military and commercial aircraft parts to Iran. 

A Las Vegas federal grand jury has returned an indictment charging Alan Rodrigues, a former pit boss and casino owner from Henderson, Nev.; Weston Coolidge, a businessman from Las Vegas; and Joseph Prokop, a former National Football League punter from Upland, Calif., with a tax fraud scheme for their promotion of a fraudulent tax product through the now defunct National Audit Defense Network (NADN).

The Department today filed suit against Ronald D. Peterson and Glen E. Johnson, the owner and rental manager, respectively, of 11 single family homes in Ypsilanti, Mich., alleging a pattern or practice of sexual harassment of female tenants.

A former high-level shipping executive was sentenced today to serve 48 months in jail and to pay a $20,000 criminal fine for his role in an antitrust conspiracy involving the transportation of goods to and from the continental United States and Puerto Rico by ocean vessel. This is the longest jail sentence ever imposed for a single antitrust charge.

Jimmy “Jimbo” Sullivan, the former chief of police in Mendenhall, Miss., pleaded guilty today to a felony civil rights violation, admitting that he used excessive force when he repeatedly stomped on the head of an arrestee.

Timothy Oldani, 24, of Scott Depot, W.Va., and Joseph Oldani, 21, of Camp Lejeune, N.C., both pleaded guilty today in the Southern District of West Virginia to conspiring to steal military optics from the U.S. Marine Corps and illegally export them from the United States.

A federal grand jury in San Francisco returned an indictment against two former executives from Chunghwa Picture Tubes Ltd. (Chunghwa) and one former executive from LG Display Co. Ltd. (LG) for their participation in a global conspiracy to fix prices of Thin Film Transistor-Liquid Crystal Display (TFT-LCD) panels.

Raul Cortes-Meza, 21, aka “Oscar”, a Mexican national, pleaded guilty today in U.S. District Court in Atlanta to sex trafficking of a minor from Mexico.

Two men have been arrested and charged in an indictment unsealed today with crimes related to sex trafficking. Tommy Handy and his nephew, Everett Cooney, were indicted by a federal grand jury in Little Rock, Ark., for conspiracy to commit sex trafficking and sex trafficking for their roles in using force, fraud and coercion to cause juvenile girls and adult women to engage in commercial sex acts.

Carlos Serrano, 64, of Glendale, Calif., was sentenced to 18 months in a community correctional facility in connection with a $1.3 million scheme to defraud the First International Bank of Connecticut (FIB) and the Export-Import Bank of the United States (Ex-Im Bank). In addition to his prison sentence, Serrano was placed on five years of probation and ordered to pay restitution of $924,569 to the Ex-Im Bank.

A federal grand jury in San Francisco today returned a two-count indictment against the former Chairman and Chief Executive Officer of Chunghwa Picture Tubes Ltd. for his participation in global conspiracies to fix prices of two types of cathode ray tubes (CRTs) used in computer monitors and televisions.

A former member of the U.S. armed services pleaded guilty today in the U.S. District Court for the District of Arizona in Tucson for his role in a widespread bribery and extortion conspiracy. The charges arise from Operation Lively Green, an undercover investigation conducted by the FBI that began in December 2001. To date, 56 additional defendants have been sentenced for their roles in the conspiracy.

The United States has sued a Dallas tax preparer, Tina Preston, her tax-preparation firm – Preston Tax Services, Inc. – and several other individuals associated with the firm, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Dallas with the U.S. District Court for the Northern District of Texas.

Five defendants, all members or associates of an extended family, face potential life sentences after being found guilty of sex trafficking for participating in a scheme that lured young Central American women and girls into the Los Angeles area and forced them into prostitution. The defendants, four Guatemalan nationals and one Mexican citizen, were convicted on Feb. 11, 2009, of conspiracy; sex trafficking by force, fraud or coercion; and importation of aliens for purposes of prostitution.

Timothy Kyle Dunaway, 24, of Wichita Falls, Texas, was sentenced today to 41 months in prison by U.S. District Court Judge Reed O’Connor in Wichita Falls for selling counterfeit computer software through the Internet in violation of criminal copyright infringement laws. The software sold by Dunaway had a combined retail value of more than $1 million.

BP Products North America Inc. has agreed to spend more than $161 million on pollution controls, enhanced maintenance and monitoring, and improved internal management practices to resolve Clean Air Act violations at its Texas City, Texas, refinery.

Leonard Fox a/k/a Anton a/k/a “Daddy” pleaded guilty today to a federal civil rights charge for sex trafficking of minors. In U.S. District Court in Memphis, Fox admitted to recruiting and obtaining underage girls and arranging for those girls to engage in commercial sex acts for his financial benefit.

A former employee of the Export-Import Bank of the United States (Ex-Im Bank) has been indicted on corruption and tax violations arising from her alleged receipt of a $100,000 bribe while working at the Ex-Im Bank.

Miguel Caro Quintero, the alleged former leader of the now-defunct Sonora Cartel, was extradited by the government of Mexico to the United States on Feb. 25, 2009. Miguel Caro Quintero arrived in the United States yesterday and has been transferred to the District of Colorado to face charges including racketeering and narcotics trafficking.

Miguel Angel Mejia-Munera, a/k/a “El Mellizo,” was extradited today from Colombia to the United States to face narcotics trafficking charges. According to the indictment, Miguel Angel Mejia-Munera, together with his twin brother Victor, led a major Colombian narcotics trafficking organization known as “the Twins” or “Los Mellizos” Organization.

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.

The Department today filed a lawsuit in U.S. District Court for the Central District of Illinois against Henry County, Ill., alleging that former employee Michelle Baze was sexually harassed by her supervisor, in violation of Title VII of the Civil Rights Act of 1964. Title VII prohibits discrimination in employment on the basis of sex, race, color, national origin or religion.

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.

Five U.S. defendants convicted for their activity in a global child pornography trafficking enterprise were sentenced today in the Northern District of Florida. The defendants had pled to multiple charges, including engaging in a child exploitation enterprise; conspiracy to advertise, transport, ship, receive and possess child pornography; advertising child pornography; transporting child pornography; and receiving child pornography.