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) 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.

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to...

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development...

Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair...

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...

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

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

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

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.

The coronavirus pandemic is likely to last as long as two years and will not be properly controlled until two-thirds of the world’s populations have become immune.

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.

The NHS has set out plans to step up its non-COVID-19 services over the next six weeks.

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.

Lonza Group AG and Moderna Inc have entered a deal to develop 1 billion doses of coronavirus vaccines a year.

A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed.

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.

New crop of data suggests drug can speed recovery from COVID-19

Ramps up capacity for testing across the country

Move comes after drug showed preliminary efficacy in clinical trial in late April

Results could unlock another big market for the company’s star drug

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India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of…

Privately-held pharma and diagnostics firm Menarini Group has announced a definitive agreement to acquire…

California’s Gilead Sciences has outlined a plan to ramp up production of newly USA-approved COVID-19…

A multi-year collaboration between China’s Innovent Biologics and USA-based Eli Lilly is bearing fruit,…

COVID-19 is having varying effects on different markets within healthcare, with drug delivery systems…

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. 

Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.

While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically.

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.

The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism.

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.

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.

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 

China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday.

One in four Portuguese with a monthly household income of 650 euros ($705) or less have lost all their income because of the economic impact of the coronavirus outbreak, a study by the National School of Public Health showed on Saturday.

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats.

A former employee of the New York Power Authority (NYPA) was sentenced today to serve 37 months in jail and to pay a $5,000 criminal fine for his role in a kickback and bribery scheme.

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).

The former vice president of reinsurance of American International Group Inc. (AIG), was sentenced today to four years in prison for his role in a fraudulent scheme to manipulate AIG’s financial statements.

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 a lawsuit on behalf of Suzanne L. Halverson, an Army National Guard member, against Grand Forks County, N.D., alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), which prohibits employers from discriminating against service-members because of their past, current or future military service obligations.

Two Florida homeland security vendor employees were sentenced today for conspiracy to commit wire fraud and honest services fraud by depriving their employers of money and the right of honest services, the Department of Justice announced today.

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.

The Department announced today the settlement of a lawsuit filed on behalf of Anthony D. Jackson, an Air Force National Guard member, against Union County College (UCC) under the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).

The United States has recovered more than $19 million from AMEC Construction Management Inc. (ACMI) to resolve allegations of fraud, false claims and kickbacks on four General Services Administration (GSA) construction contracts, as well as litigation over claims by the GSA for excess re-procurement costs incurred by GSA after it terminated ACMI’s contract to build the Thomas F. Eagleton United States Courthouse in St. Louis, Missouri. ACMI was formerly known as Morse Diesel International Inc.