The White House is considering shutting down its coronavirus task force by the end of May and handing responsibilities to FEMA even as some models project a sharp increase in COVID-19 deaths in the coming weeks.

As many as 20% to 25% of healthcare workers in hard-hit areas, experts say, are likely to develop disorders such as anxiety, depression or post-traumatic stress.

Since March, many ports are refusing to allow crew changes or shore leave.

Daymond John hates to be the bearer of bad news, but he thinks all signs point to our economic recovery being kinda like watching paint dry -- slow and painful. The "Shark Tank" star was on "TMZ Live" Friday to talk about the unique economic…

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA).  This law

The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

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 […]

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]

Washington, D.C. – Consumer Protection and Commerce Subcommittee Chair Jan Schakowsky (D-IL) and Ranking Member Cathy McMorris Rodgers (R-WA) today announced that the Subcommittee will hold a teleconference forum on Monday, May 11, at 12 p.m. (EDT) with Federal Trade Commission (FTC) Chairman Joseph J. Simons to discuss critical consumer protection issues related to the COVID-19 pandemic. “The COVID-19 pandemic has brought about significant consumer protection concerns that fall under the purview of the FTC, including COVID-19 related scams, price gouging, privacy and data security issues, and more,” Schakowsky and McMorris Rodgers said.  “We look forward to hearing from Chairman Simons about the steps FTC is taking to ensure consumers are protected during this pandemic.”      This forum is open to the press.  Credentialed reporters interested in listening to the forum live should RSVP to Evan.Gilbert@mail.house.gov by 5 pm on Friday, May 8.   ###

Business chief Jonathan Symonds has joined British multinational GlaxoSmithKline as the company’s new non-executive chairman.

The hire ends GSK’s six month search, as it prepares to fold its consumer business into a joint venture with Pfizer. In his new role Symonds will oversee the changes being implemented by CEO Emma Walmsley who joined GSK in 2017. Walmsley hopes to revitalise GSK’s R&D efforts with the help of Chief Scientific Officer Hal Barron.

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Topics include off-label and compassionate drug use for COVID-19 and utilization and cost of naloxone for patients at high risk of opioid overdose.

The post Monthly Round-Up of What to Read on Pharma Law and Policy appeared first on Bill of Health.

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.

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.

The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine.

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

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.

Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone.

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

UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive…

India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to…

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.

Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns.

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.

A federal indictment was unsealed today in U.S. District Court for the District of Oregon charging Harold James Nicholson, 58, of Sheridan, Ore., and Nathaniel James Nicholson, 24, of Eugene, Ore., with two counts of Conspiracy, one count of Acting as Agents of a Foreign Government, and four counts of Money Laundering.

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.

A government contractor and former employee of the U.S. Department of the Treasury was sentenced in Washington today in connection with a bribery scheme involving contracts at the U.S. Tax Court in the District of Columbia. Daniel Money, 44, of Shady Side, Md., was sentenced by U.S. District Judge Ricardo M. Urbina of the U.S. District Court for the District of Columbia, to 30 months in prison, three years supervised release and a $7,500 fine.

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.

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.

The government filed a lawsuit today in Miami against Swiss bank UBS AG. The lawsuit asks the court to order the international bank to disclose to the Internal Revenue Service (IRS) the identities of the bank’s U.S. customers with secret Swiss accounts. According to the lawsuit, as many as 52,000 U.S. customers hid their UBS accounts from the government in violation of the tax laws.

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.

Rodrigo Molina, 33, a Brazilian national who resided in Miami, was found guilty by a federal jury on 11 of 16 charged counts related to a $13.5 million money laundering conspiracy. Molina was found guilty on Feb. 25, 2009, following a seven-day jury trial in U.S. District Court for the Southern District of Florida.

A former U.S. Department of Energy (DOE) employee who falsified his performance evaluation to justify an annual performance award to which he was not entitled pleaded guilty today to one count of making false statements.

Marshall E. Sanders, an attorney based in Vicksburg, Miss., was sentenced to 18 months in prison for failure to file tax returns by Magistrate Judge James C. Sumner. In addition, Judge Sumner ordered Sanders to pay restitution to the IRS of $1,025,453.

The sister of a U.S. Army officer has pleaded guilty for her participation in a money-laundering scheme related to bribes paid for contracts awarded in support of the Iraq war. Carolyn Blake, of Sunnyvale, Texas, pleaded guilty to one count of money laundering conspiracy after accepting more than $3 million in bribe proceeds on behalf of her brother, Major John Cockerham.

Alberto Goachet, 67, a political consultant and aide to former Puerto Rico Sen. Jorge De Castro Font, was sentenced today to three months in prison, three months of home detention and three years of supervised release. Goachet pleaded guilty on Dec. 4, 2008, to a one-count information charging him with conspiring with De Castro Font and others to launder money provided by a Puerto Rico businessman to De Castro Font.

A former Michigan school official was sentenced to serve 46 months in jail and to pay $1.34 million in restitution for his role in a fraudulent scheme to obtain millions of dollars from the Detroit-area Ecorse Public School District, the federal E-Rate program and TCF National Bank. Douglas Benit, a former assistant superintendent at Ecorse Public Schools (EPS), was sentenced in the U.S. District Court in Detroit today after pleading guilty on Nov. 24, 2008, to one count each of mail fraud and bank fraud.

Harris Taubman, of Hyannis, Mass., was sentenced today in U.S. District Court in Boston for receiving and possessing child pornography. Taubman, 48, was sentenced to 84 months in prison for three counts of receipt of child pornography and one count of possession of child pornography. He was indicted on those charges on Feb. 6, 2008, and pled guilty on Feb. 11, 2009.

Two former National Century Financial Enterprises (NCFE) executives were sentenced today for their roles in a scheme to deceive investors about the financial health of NCFE. NCFE, formerly based in Dublin, Ohio, was one of the largest healthcare finance companies in the United States until it filed for bankruptcy in November 2002.

The Department announced that on April 7, 2009, it will monitor the election in Kane County, Ill., to ensure compliance with the Voting Rights Act of 1965, as amended. Under the Voting Rights Act, the Justice Department is authorized to ask the Office of Personnel Management to send federal observers to areas that are specially covered in the act or by a federal court order.

A physicist in Newport News, Va., was sentenced to 51 months in prison today for illegally exporting space launch technical data and defense services to the People’s Republic of China and offering bribes to Chinese government officials. Shu Quan-Sheng, 68, a native of China, naturalized U.S. citizen and Ph.D. physicist, was sentenced by Judge Henry C. Morgan, Jr. in U.S. District Court for the Eastern District of Virginia, Norfolk Division.

A former owner of an asbestos monitoring contractor that provided services to New York Presbyterian Hospital (NYPH) pleaded guilty today for making false statements to FBI agents and representatives of the Department’s Antitrust Division. Stephen E. McAnulty, of Brooklyn, N.Y., pleaded guilty in U.S. District Court in Manhattan, for lying about his knowledge of a kickback and fraud conspiracy that took place at NYPH.

The Department today asked a federal court in Denver to approve service of a John Doe summons on First Data Corporation. “John Doe” summonses allow the IRS to obtain information about United States taxpayers whose identities are not yet known. The information expected in response to the summons will help the IRS identify merchants who use offshore accounts to evade their United States tax liabilities.

A federal grand jury has returned an 18-count superseding indictment charging Thomas E. Parenteau of Columbus, Ohio; Dennis G. Sartain of Hilliard, Ohio; and Bonnie Helt-Adams of Dublin, Ohio, with tax fraud, bank and wire fraud, money laundering and obstruction of justice.

The Department announced that on May 5, 2009, it will monitor municipal elections in the towns of Cleveland, Como, Meridian and Sardis, Miss., to ensure compliance with the Voting Rights Act of 1965.

Marsha K. Parenteau of Columbus, Ohio, pleaded guilty today to conspiracy to commit money laundering. Parenteau appeared before Judge Michael H. Watson in Columbus.

Two former managers of the Bank of China and their wives were sentenced today after their convictions on Aug. 29, 2008, by a federal jury in Las Vegas on charges of racketeering, money laundering, international transportation of stolen property as well as passport and visa fraud.

On May 9, 2009, the Department of Justice will monitor municipal elections in the cities of Farmers Branch and Hondo, Texas, to ensure compliance with the Voting Rights Act of 1965.

"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."