by Stephanie D. Fischer BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act.  The letter is posted on our website and the text is below: “On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment […]

The Japanese pharma development firm will harness risk-based quality management solutions to help sponsors improve trial quality and safety.

Unified theory describes formation of huge, mysterious waves

-- Read more on ScientificAmerican.com

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

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.

There is a duty to ensure access to innovative treatments for patients with unmet need, but a health service gatekeeper must commit to efficient use of limited resources. Matt Fellows looks at how real-world evidence could be the key to reassessing how we determine the value of these drugs and ensure their swift availability.

COVID-19 continues to dominate the news cycle as we all try to maintain business as usual under the shadow of the pandemic. Just about every area of society and business has been hit and Life Sciences is no exception; the impact of the virus has been felt in every corner of the industry and our monthly issues aim to cut through the confusion to shed a light on that impact.

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.

Tokyo’s Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) for trastuzumab deruxtecan…

Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2…

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. 

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.

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.

The Department today announced that it has reached a consent decree with the Policía de Puerto Rico (Puerto Rico Police Department or PRPD) that will, if approved by the federal district court, resolve a complaint the Department filed in March 2008 alleging that the PRPD engaged in unlawful employment discrimination based on gender and retaliation, in violation of Title VII of the Civil Rights Act. Title VII prohibits employment discrimination on the basis of race, color, sex, national origin and religion, and also prohibits retaliation against persons for filing charges of discrimination.

A federal court in Maine permanently barred Donna L. Hamilton from preparing federal tax returns for others. The court also ordered the Maine resident to provide her customer lists to the government and to mail copies of the court order to her customers. Hamilton consented to the civil injunction order.

The Department today filed a lawsuit against the Wayne County Housing Authority (WCHA), in Fairfield, Ill., as well as Jill Masterson and Danna Sutton, WCHA’s executive director and assistant director, respectively, alleging that they violated the Fair Housing Act when they tried to discourage a white couple from renting their property in Fairfield to an African-American woman.

The United States has sued Robert Cusenza, a West Palm Beach tax return preparer, seeking to bar him permanently from the tax preparation business. The government’s complaint asks the court to order Cusenza to stop preparing returns and to turn over his customer list to the Justice Department.

The United States has filed suit against a Jacksonville, Fla., tax return preparer, seeking to shut down her business. According to the government complaint, Shirley Clark, who operates the Nichet Corp., has prepared at least 1,250 federal tax returns for her customers from 2004 until 2007 and, on those returns, Clark has claimed nearly $750,000 in fraudulent fuel tax credits.

The President released the Administration’s FY 2010 top-line budget proposal today which includes $26.5 billion for the Department, a 3.5 percent increase more than the FY 2009 budget. The Department’s budget includes enhanced funding for: national security and intelligence; combating financial fraud; hiring additional police officers; civil rights enforcement; securing our nation’s borders; and for federal detention and incarceration programs.

After nearly 13 years as a fugitive, a former New Jersey resident has been returned to the United States, and pleaded guilty today to conspiring to committing one of the nation’s largest known motor fuel excise tax schemes. Aaron Misulovin a/k/a Albert Friedman, a/k/a Valery Vibornov, pleaded guilty before U.S. District Judge Joseph E. Irenas in Camden, N.J., to one count of conspiracy, three counts of wire fraud, three counts of money laundering and three counts of tax evasion.

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.

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 Department today filed a lawsuit against Bobby L. Hurt, the former property manager for numerous mobile homes in and around West Memphis, Ark., alleging a pattern or practice of sexual harassment. The lawsuit also names Bobby Hurt=s wife, Sue Hurt, as a defendant.

The United States has asked a federal court in Savannah, Ga., to permanently bar Ophelia Kelley of Vidalia, Ga., from preparing federal income tax returns for others. According to the government complaint, Kelley operates two return preparation firms in Vidalia – Kelley Tax Service, and City and Country Girl Tax Service.

The government has filed two lawsuits against the Union Pacific Railroad Company for allegedly failing to prevent the use of its rail cars to smuggle large quantities of narcotics into the United States. The complaints, filed in San Diego and Houston, seek more than $37 million in monetary penalties. The government alleges the rail cars were brought across the border at the ports of entry at Calexico, Calif., and Brownsville, Texas.

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.

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.

As homeowners and communities throughout the country continue to face devastating consequences from the deep contraction in the economy and the housing market, the Obama Administration today announced a new coordinated effort across federal and state government and the private sector to target mortgage loan modification fraud and foreclosure rescue scams that threaten to hurt American homeowners and prevent them from getting the help they need during these challenging times.

Quest Diagnostics Incorporated and its subsidiary, Nichols Institute Diagnostics (NID), have entered into a global settlement with the United States to resolve criminal and civil claims concerning various types of diagnostic test kits that NID manufactured, marketed and sold to laboratories throughout the country until 2006. The payment of $302 million will resolve these allegations and represents one of the largest recoveries ever in a case involving a medical device.

The Department told the U.S. District Court for the District of Columbia today that it is necessary to extend the term of certain portions of the Microsoft final judgment by at least 18 months. The Department said that an extension is necessary to ensure the quality of the technical documentation Microsoft provides to licensees.

A federal grand jury returned an indictment today charging Robert Jeffery, 55, with conspiracy and theft of government property in connection with a scheme to steal large quantities of fuel from the U.S. Army in Iraq.

The Department has filed a lawsuit in U.S. District Court in Philadelphia against Nobel Learning Communities Inc. (Nobel) alleging the company violated Title III of the Americans with Disabilities Act by excluding children with autism spectrum disorders and other disabilities from its schools and programs.

The Department today filed suit against the Fitchburg Housing Authority in Fitchburg, Mass., and its Executive Director Robert W. Hill alleging that they violated the Fair Housing Act when they refused to allow a tenant to transfer to a different apartment as a reasonable accommodation for her disabilities.

A federal court in Savannah, Ga., today permanently barred Ophelia Kelley, of Vidalia, Ga., from preparing federal income tax returns for others. According to the government complaint, Kelley operated two return preparation firms in Vidalia – Kelley Tax Service and City and Country Girl Tax Service. Kelley agreed to the civil injunction order.

The Department has filed suit against the town of Garner, N.C., and the town’s board of adjustment alleging that they violated the Fair Housing Act when they refused to allow up to eight men recovering from drug and alcohol addictions to live together as a reasonable accommodation for their disabilities.

A federal grand jury returned a superseding indictment today charging Robert Young, 56, a former captain in the U.S. Army, and Robert Jeffery, 55, a former master chief petty officer in the U.S. Navy, with conspiracy and theft of government property in connection with a scheme to steal large quantities of fuel from the U.S. Army in Iraq.

Five defendants were sentenced this week for their participation in a corruption scheme involving the 2000 resident commissioner and 2004 gubernatorial campaigns of a former governor of Puerto Rico.

The Department has filed suit against convicted tax fraud promoter Daniel Andersen to enjoin him from promoting fraudulent tax schemes. The government’s complaint alleges that Andersen directed the activities of both the Institute for Global Prosperity (between 1996 and 2002) and the Stratia Corporation (between 2002 and 2004). The lawsuit states that Andersen used these organizations to promote the fraudulent tax schemes sold by others in a series of audio recordings and at offshore conferences.

Eight members of the violent gang known as the "Almighty Latin King and Queen Nation" (ALKQN) have pleaded guilty to a variety of charges, including drug conspiracy and weapons trafficking.

At the eighth annual International Competition Network (ICN) conference in Zurich, Switzerland, the ICN adopted new Recommended Practices for substantive merger analysis and presented two new reports on the analysis of tying and bundled discounting and loyalty discounts and rebates under unilateral conduct laws.

Raschad L. "Sean" Lewis, a former fuel section employee of Kellogg Brown and Root Inc. (KBR), assigned to Bagram Airfield in Afghanistan, was found guilty yesterday by a federal jury of conspiracy, false writing, bribery of a public official, and false claims stemming from a bribery and a fuel diversion scheme.

The Department of Justice, UBS and the Swiss government have requested a stay with a rescheduled hearing date of Aug. 3, 2009, in the proceedings for enforcement of the summons ordering UBS to turn over records of account holders.

The Department of Justice and Department of Defense today announced that the Detention Policy Task Force, which was created pursuant to Executive Order 13493, has issued a preliminary report on military commissions and a process for the determination of prosecution forum for trials of suspected terrorists.

Robert Young, 56, a former captain in the U.S. Army, pleaded guilty today to participating in a scheme to steal fuel worth approximately $39.6 million from the U.S. Army in Iraq.

A Virginia man pleaded guilty today to participating in a scheme to steal fuel worth approximately $39.6 million from the U.S. Army in Iraq.

The United States has filed a False Claims Act lawsuit against First Choice Armor & Equipment Inc. and its founder, Edward Dovner, for submitting false claims for bullet-proof vests purchased by the United States for federal, state, local and tribal law enforcement agencies.

Ohio Edison Company, a subsidiary of FirstEnergy Corp., has agreed in a consent decree to repower one of its coal-fired power plants using primarily renewable biomass fuels.

Robert Jeffery, 55, was convicted today by a federal jury in Alexandria, Va., for his role in a scheme to steal fuel worth approximately $39.6 million from the U.S. Army in Iraq.