Nordic Nanovector has appointed Dr Lars Nieba as the interim Chief Executive Officer. He is currently the company’s Chief Technology Officer and replaces Eduardo Bravo who as of today has left Nordic to pursue other career opportunities.

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This was the first time in a long time that I’ve renewed my nursing license with the thought that I might need it — that I might be needed.

The post Preparing to Go Back to the Bedside During COVID-19: A Nurse-Turned-Bioethicist Reflects appeared first on Bill of Health.

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

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.

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

Additional donations of chloroquine sent to governments in numerous other countries / Various clinical and preclinical studies investigate the efficacy and adverse effects in COVID-19 infections / Bayer plans considerable expansion of production capacities in the event that the efficacy of chloroquine is proven for COVID-19

Investigation of combination therapies including Bayer’s chloroquine and interferon beta-1b to foster much needed solutions for patients in fight against coronavirus pandemic / Bayer Canada to make CAD 1.5 million (approximately 1 million euros) financial commitment and to supply products in support of the research / Plans to include more than 60 contributing research locations involving 6.000 patients

Employee safety and business continuity are top priorities / Wide-ranging humanitarian and social engagement / Group sales increase by 6.0 percent (Fx & portfolio adj.) to 12.845 billion euros / EBITDA before special items up by 10.2 percent to 4.391 billion euros / All divisions report higher sales and earnings – strong demand at Consumer Health / Net income advances by 20.0 percent to 1.489 billion euros / Core earnings per share increase by 9.9 percent to 2.67 euros / Outlook for 2020: impact of COVID-19 not yet reliably quantifiable

ICI executive who helped turn its bioscience business into the pharmaceuticals giant AstraZeneca

Sir David Barnes, who has died aged 84, was the self-effacing but determined and clear-sighted chief executive who turned the bioscience interests of ICI into one of the world’s major pharmaceutical corporations, AstraZeneca.

Teased at its launch in 1993 that Zeneca sounded like a Czechoslovakian camera, Barnes responded that its performance would define its brand – and was vindicated. The first suggested name had been Zenica, but then Barnes, tracking the Bosnian conflict days before the launch, found to his horror that hostilities were threatening to spread to a previously unremarked town of that name. Alarmed that it “could become as notorious as Guernica”, he changed the spelling and held his breath.

NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year.

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.

Ousted Director of the Biomedical Advanced Research and Development Authority (BARDA), Dr Rick Bright, alleges the Trump administration ignored warnings about the severity of the coronavirus.

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Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based…

Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing…

Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and…

Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…

The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules…

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. 

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting.

Five commercial fishermen in St. Mary’s County, Md., a fish wholesaler, its owner and an employee have been charged in Maryland and Washington, D.C., for their role in the illegal harvest, sale, and purchase of hundreds of thousands of pounds of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.

Ralph Nicoletti pleaded guilty in Brooklyn, N.Y., federal court today before U.S. District Judge Carol B. Amon to committing three assaults targeting African-American residents in Staten Island, N.Y., on the night of President Barack Obama’s election victory. Nicoletti was the last of four defendants to plead guilty in the federal prosecution stemming from the attacks.

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.

A federal court in Maine has permanently barred Robert A. Grover from preparing federal tax returns for others. The court also ordered the Maine resident to provide his customer lists to the government and to mail copies of the complaint and court order to his customers. Grover consented to the civil injunction order.

A federal district court in Connecticut has permanently barred Elda Sinani, a resident of that state, from preparing federal tax returns for others. Sinani consented to the civil injunction order.

A former employee at the U.S. Embassy in Haiti pleaded guilty today to one count of theft for stealing more than $800,000 from the U.S. Department of State. According to court documents, Jean G. Saint-Joy, 25, a citizen of Haiti, was employed as a cashier by the U.S. Embassy in Port-au-Prince, Haiti, from approximately 1995 until July 2008.

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.

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.

Five St. Mary’s County, Md., commercial fisherman pleaded guilty today to illegally overfishing striped bass also known as rockfish.

The Department issued a statement today after JBS and National Beef announced the abandonment of the JBS/National Beef transaction, which the Department had filed suit to block in October.

A federal district court in Tennessee has permanently barred Chattanooga resident Demita Brown-Watkins from preparing federal income tax returns for others. Brown-Watkins agreed to the civil injunction order. According to the government complaint, Brown-Watkins ran her tax-preparation business through two companies—Fastax and Rapid Tax Service—and advertised the “largest refund in town.”

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.

A federal court has permanently barred Harold Mette of Bradenton, Fla., from preparing federal income tax returns for others. Mette, who has a Ph.D. degree and calls his business “The Tax Doctor,” consented to the permanent injunction order, which was entered by U.S. District Judge Richard A. Lazzara in U.S. District Court for the Middle District of Florida.

The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs. At the same time, KV agreed to the injunction in a consent decree.

The Department filed a lawsuit today against JPI Construction L.P. (JPI) and six JPI-affiliated companies in U.S. District Court in Dallas for failing to provide accessible features required by the Fair Housing Act and the Americans with Disabilities Act at multi-family housing developments in Texas and other states.

Carl Courtright III, of Granite City, Ill., was convicted today on child pornography and bank fraud charges in the Southern District of Illinois following a five-day jury trial. The federal jury convicted Courtright of one count of production of child pornography, two counts of possession of child pornography, one count of receipt of child pornography, as well as one count of bank fraud.

Building upon the successes of earlier efforts, the Department today announced the opening in Bangkok of a regional conference of approximately 100 key law enforcement and industry officials from more than a dozen nations with the goal of strengthening international cooperation in fighting large-scale intellectual property crimes.

A British citizen was charged in connection with the operation of a series of fraudulent business opportunities on March 10, 2009, by a Miami federal grand jury. Sirtaj Mathauda was indicted on charges that he and his co-conspirators purported to sell vending machine, beverage and greeting card business opportunities, including assistance in establishing, maintaining and operating such businesses. The charges form part of the government’s continued nationwide crackdown on business opportunity fraud.

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.

A current Baltimore City Police Department officer and two retired officers were charged in a six-count federal indictment unsealed today with civil rights and obstruction of justice violations stemming from an April 2004 incident during which officers allegedly assaulted a handcuffed and shackled juvenile with a baton and pool stick.

Nathan Davis, a former police officer with the Baton Rouge Police Department in Baton Rouge, La., pleaded guilty today to a felony civil rights violation for use of excessive force. At today’s court hearing, defendant Davis admitted that he intentionally used excessive force in March 2007 against a man who had been arrested, handcuffed and taken to a police department holding center.

The United States has sued four Certified Public Accounts (CPA), 27 tax preparers and one other individual, seeking to bar them from promoting an alleged tax scam involving bogus income tax credits claimed for sham sales of methane from landfills.

The increased efforts and reallocation of personnel recently announced by the Department of Justice builds on the foundation of expertise and experience gained from ongoing efforts to combat Mexican drug cartels in the United States and to help Mexican law enforcement battle cartels in its own country.

U.S. District Court Judge Robert W. Gettlemen entered an order barring tax preparers, Michael J. Singleton and his wife, Ladonna Singleton, from preparing federal tax returns for others. The court’s ruling came after the Singletons failed to defend against the government’s allegations.

Tax return preparer Lawrence Sperling pleaded guilty today to aiding in the preparation of false tax returns. Sperling was scheduled to begin trial on April 14, 2009 before Judge Deborah Chasanow in Greenbelt, Md. According to the indictment and the plea agreement, Sperling knowingly prepared tax returns for his clients that contained false and fraudulent items, including inflated medial expenses, charitable contributions, miscellaneous employment-related expenses, and child care credits.

Robert Moran, of Lighthouse Point, Fla., pleaded guilty today to a criminal information charging him with filing a false income tax return. Moran appeared today before Judge James I. Cohn in Ft. Lauderdale and accepted responsibility for concealing more than $3 million in assets in a secret bank account at UBS in Switzerland.

The Department announced that a federal district court judge in Louisville, Ky., approved a settlement of the Department’s lawsuit alleging that those involved in the design and construction of 12 multifamily housing complexes discriminated on the basis of disability. The complexes contain more than 800 units covered by the Fair Housing Act’s accessibility provisions.

A federal court has permanently barred Donald Morris of Bloomfield, Conn., from preparing federal income tax returns for others. Morris consented to the permanent injunction order, which was entered by U.S. District Court Judge Jane C. Hall in the U.S. District Court for the District of Connecticut.