LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals ECG Remote Monitoring Patch. The patch, integrated with a remote monitoring platform, is designed as a continuous electrocardiography (ECG) and heart rate monitor. The ECG Remote Monitoring Patch is disposable and captures data for up to three days. The device […]

Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.   Microsoft argued for a lower “preponderance […]

Remdesivir, the investigational Gilead Sciences antiviral drug, looks more likely than ever to become the first treatment authorized by the FDA to treat patients with COVID-19. National Institute of Allergy and Infectious Diseases (NIAID) head Anthony Fauci praised the drug after preliminary data released this week from a federally funded trial involving more than 1,000 […]

Regulators on Friday afternoon granted emergency authorization for the Gilead Sciences drug remdesivir as a treatment for patients hospitalized with severe COVID-19 infections. The decision makes the antiviral drug, which is delivered via intravenous infusion, the second drug to receive authorization under the FDA’s emergency guidelines for use against the novel coronavirus. The first was […]

The solutions enable continuous remote monitoring of body temperature and other vitals, either at home or in care centers, for clinical trials.

The companyâs SiteVault Free tool, designed to enable collaborating between sites and study monitors, now has a remote monitoring feature.

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.

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.

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

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

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

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

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.

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. 

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.

The Department announced today the resolution of the lawsuit filed by the United States against the state of Vermont to enforce the reporting requirements of the Uniformed Overseas Citizen Absentee Voting Act (UOCAVA). UOCAVA is designed to ensure that members of the uniformed services and overseas citizens may effectively participate in federal elections.

The Department of Justice has initiated removal proceedings against a Sharon, Penn., resident who served as an armed SS guard at two Nazi concentration camps in Germany during World War II.

"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."

"With power and wealth must come responsibility and caring. You must realize that you possess real and symbolic power as lawyers and understand that you can change the whole of America for the better."

"You will be starting your service at a time when your government is placing a new and long overdue value on the scientific skills you have developed in this program."

"Graduates, as you dive head first toward tomorrow, I call upon you to never loosen nor lose your grip on hope. The optimism that seems to come naturally with youth need not be lost as the years pass."

"Preventing the sexual exploitation of children, and stopping and punishing those who do it are a leading priority. The Department aggressively enforces the laws at our disposal to protect our children."

A defense contractor has pleaded guilty to wire fraud and has admitted to engaging in other bribery-related conduct in connection with contracts in Iraq. According to the plea agreement filed in the U.S. District Court in the District of Columbia on Dec. 18, 2007, and unsealed today, Diana Bakir Demilta, a U.S. citizen, pleaded guilty to one count of wire fraud.

Attorney General Eric Holder today vacated the order issued in Matter of Compean by Attorney General Mukasey in January and announced his intention to initiate a new rulemaking proceeding for regulations to govern claims of ineffective assistance of counsel in removal proceedings.

The Department of Justice today asked the U.S. Court of Appeals for the Ninth Circuit to remand the cases of former Alaska State Representatives Victor Kohring and Peter Kott, who were convicted on corruption charges in 2007, to the District Court.

Media executive John C. Malone will pay a $1.4 million civil penalty to settle charges that he violated premerger reporting and waiting requirements when he acquired Discovery Holding Co. voting securities. The Department’s Antitrust Division, at the request of the Federal Trade Commission, filed a civil antitrust lawsuit today in U.S. District Court in Washington, D.C., against Malone for violating the notification requirements of the Hart-Scott-Rodino (HSR) Act of 1976. At the same time, the Department filed a proposed settlement that, if approved by the court, will settle the charges.

There is no tension between a sentencing scheme that is effective and fair and one that is tough and equitable. We must work toward these twin goals and we must do so now.

The operator and manager of the Rathbone Retirement Community in Evansville, Ind., has agreed to pay up to $116,000 to resolve a housing discrimination lawsuit. The November 2008 lawsuit alleged that the defendants violated the Fair Housing Act by prohibiting the use of motorized wheelchairs and scooters in residents’ apartments and in the home’s common dining room during meals.

Former New York State Supreme Court Justice Thomas J. Spargo was convicted today by a federal jury in Albany, N.Y., of attempted extortion and soliciting a bribe.

The Department has initiated removal proceedings against a Troy, Mich., resident based on his participation in violent acts of persecution while serving as an armed member of the Nazi-sponsored Ukrainian Auxiliary Police (UAP) in occupied L’viv, Ukraine, during World War II.

“A noose is an unmistakable symbol of hatred and violence in our nation, conjuring up images of a despicable period in our history. Mailing a noose to an individual who advocates for racial equality sends a clear threat of violence,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division.

Attorney General Holder recognizes 247 department employees and 39 other individuals outside of the department for their distinguished public service today at the 57th Annual Attorney General Awards Ceremony.

"The recipients we honor here today could all be making a lot more money working somewhere else, and could certainly spend more time with their families doing other jobs. But they have all answered the call to duty, the call to service that binds us together."

The United States alleges that the state of New York has failed to house thousands of individuals with mental illness who currently reside in large, institutional “adult homes” in the most integrated setting, in violation of Title II of the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act.

"We must be open to new ideas and new approaches. We must learn from each other what has worked – and what has not. We must acknowledge the cultural diversity among tribal communities and embrace the challenge of providing services that are culturally and linguistically tailored. We must dare to think differently."

"I’m honored to participate in ALPACT’s first annual banquet, and I’m grateful for the opportunity to discuss an issue that I care about deeply – fostering collaboration between law enforcement agencies and the communities they serve," said Attorney General Holder.

A federal court in Boston issued a judgment against Excel Home Care Inc. in the amount of $473,510.76 for unpaid federal employment and unemployment taxes after its owner Diane E. Porter consented to the entry of an order of permanent injunction that prohibits her or anyone else from operating this Tewksbury, Mass., home health care provider.

"Laurie and Ron are not only valued colleagues, they are leaders in the Department and throughout this Administration," said Attorney General Holder.

Former New York State Supreme Court Justice Thomas J. Spargo was sentenced today by U.S. District Judge Gary Sharpe in Albany, N.Y. to 27 months in prison followed by two years of supervised release for attempted extortion and bribery, Assistant Attorney General Lanny A. Breuer of the Criminal Division and Special Agent in Charge John F. Pikus of the FBI’s Albany office announced.

The settlement requires the companies to pay a total of $900,000 in civil penalties for violating premerger waiting period requirements.