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.

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.

Initial roll-out will see key workers utilise the app

It is hoped that the drug may prevent COVID-19

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

Positive top-line data for a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo (cemiplimab)…

Shares of US biotech Akebia Therapeutics were up more than 35% at $11.72 by early afternoon today, after…

The Department announced today that it has filed a lawsuit on behalf of Kevin Stenger, an Indiana National Guard member, against Wagner Industrial Electric Inc. (Wagner), alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA). USERRA was enacted in 1994 to protect service members from being disadvantaged in their civilian careers due to serving in the uniformed services.

A Middlesex, N.J., industrial pipes, valves and fittings supply company and its co-owner pleaded guilty today to participating in a fraud conspiracy at two U.S. Environmental Protection Agency (EPA)-designated Superfund sites in New Jersey. The sites are Federal Creosote, located in Manville, N.J., and Diamond Alkali, located in Newark, N.J.

The Department has entered into a consent decree with Wagner Industrial Electric Inc. that, if approved by the court, will resolve the Department’s complaint the company failed to properly reemploy Indiana Army National Guard Reservist Kevin Stenger in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).

Michael Fisher, owner of Fisher Sand & Gravel Co. Inc. (FSG), based in Dickinson, N.D., today pleaded guilty to nine felony counts of tax fraud.

Donald Sikma, a businessman from Dyer, Ind., has pleaded guilty to filing a false tax return. Sikma, whose trial was scheduled to begin today, entered his guilty plea Monday before Judge Theresa L. Springmann in Fort Wayne, Ind.

Haji Bagcho, aka Haji Bagh Chagul, an Afghan national, was ordered detained today by Magistrate Judge John M. Facciola in U.S. District Court for the District of Columbia while he awaits trial on U.S. narcotics charges.

Bradley C. Brennecke, a resident of Pleasant Plain, Ohio, and Bruce A. Mrusek, a resident of Maineville, Ohio, pleaded guilty late Tuesday to conspiracy and tax evasion charges before District Court Judge Michael R. Barrett in Cincinnati.

The United States filed two major Clean Air Act settlements to reduce air emissions from container glass and Portland cement plants throughout the country.

Jose Garcia, 55, who has been a fugitive since 2008, was taken into federal custody yesterday at Miami International Airport.

"It’s a special honor for me to address the American College of Trial Lawyers, and to share the stage today with such impressive and distinguished speakers as Justice Cromwell, Justice Kirby, Judge Sparks, and Professor Coffee."

After more than two years of legal proceedings, alleged international arms dealer Viktor Bout has been extradited to the Southern District of New York from Thailand to stand trial on terrorism charges.

GWC Valve International Inc., a company headquartered in Bakersfield, Calif., and its chief executive officer, David Meador, 52, were sentenced today in the Eastern District of California for conspiracy to export services related to industrial valves to Iran.

"Each of you has been invited because of your experience, your expertise, and your influence within your constituencies. What we have in this room today is a gathering of many of the most influential criminal justice stakeholders in the nation and we’re going to really try to leverage that influence."

"As we rededicate ourselves to this work, I can’t help but feel optimistic about where we’ll arrive – and what we will achieve – together. Not only do I look forward to hearing about the discussions that you will have – and the recommendations that you will develop – during this symposium, I look forward to our continued partnership, our continued progress, and our continued pursuit of security, opportunity, and justice for all."

"This evidence-based approach to public safety issues is important across the criminal justice spectrum. I’ve made it a top priority at OJP. Shortly after taking office in 2009, I launched my Evidence Integration Initiative – we call it E2I, for short. Our goal is to both improve the quantity and quality of research and other evidence that we generate and get that information out to the field in a useable format."

The Justice Department today reached a settlement with Brand Energy and Infrastructure Services and its subsidiary, Industrial Services LLC, resolving allegations that ISI, which provides craft services to industry, engaged in a pattern or practice of discrimination against non-citizens in the hiring and employment eligibility verification process.

A federal jury in Montgomery, Ala., convicted Nacretia Lewis today of perjury and lying to a federal agent, the Justice Department and the Internal Revenue Service (IRS) announced.

The Department of Justice and the U.S. Environmental Protection Agency (EPA) today announced an innovative environmental agreement with Ohio-based Marathon Petroleum Company that already has significantly reduced air pollution from all six of the company’s petroleum refineries.

Nacretia Lewis was sentenced today to 15 months in federal prison for perjury and lying to a federal agent, the Justice Department and Internal Revenue Service (IRS) announced. She was also ordered to serve one year of supervised release following her release from prison.

Eight individuals and a Miami-based corporation were convicted by a federal jury for their participation in a Medicare fraud scheme involving the submission of more than $50 million in fraudulent billings to Medicare.

An owner and sole operator of an environmental laboratory has been charged in U.S. District Court for the Southern District of Mississippi with falsification of records and obstructing a federal criminal investigation.

A Maryland man was found guilty by a federal jury yesterday and sentenced today to serve 30 years in prison for his participation in a global online child pornography conspiracy.

Louis Daniel Smith, 42, and Karis Delong, 38, both of Ashland, Ore., were charged with defrauding regulators and suppliers in a scheme to manufacture and sell industrial bleach as a cure for numerous illnesses, including arthritis, cancer and the seasonal flu.

At a hearing today in federal court in the Eastern District of North Carolina, Hysen Sherifi, 29, of Raleigh, N.C., was sentenced by Senior U.S. District Judge W. Earl Britt to life in prison. Sherifi’s co-defendants, Shkumbin Sherifi, 23, and Nevine Aly Elshiekh, 48, were also sentenced to 36 months and 42 months in prison, respectively, both followed by three years of supervised release.

The owner and sole operator of an environmental laboratory was found guilty yesterday in U.S. District Court for the Southern District of Mississippi of all counts of a federal indictment charging falsification of records and obstructing a federal criminal investigation.

The United States has extradited Sulejman Mujagic, a citizen of Bosnia and Herzegovina and a resident of Utica, N.Y., to stand trial in Bosnia for charges relating to the torture and murder of one prisoner of war and the torture of another during the armed conflict in Bosnia.

The Justice Department announced today that a federal grand jury in Baton Rouge, La., returned an indictment yesterday charging Anthony Williams and Bobby Riley with conspiring to threaten to retaliate against a witness in a federal trial, threatening to retaliate against a witness in a federal trial and making false statements to federal agents.

Tennie White, the owner and operator of an environmental laboratory located in Jackson, Miss., was sentenced in federal court late yesterday to 40 months in prison in connection with her conviction for faking laboratory testing results and lying to federal investigators, announced Gregory K. Davis, U.S. Attorney for the Southern District of Mississippi, and Robert G. Dreher, Acting Assistant Attorney General for the Justice Department’s Environment and Natural Resources Division.

The Justice Department announced today that Anthony Williams, a resident of Baton Rouge, La., pleaded guilty today to one count of threatening to retaliate against a witness in a federal criminal tax trial.

An unlicensed nurse who fled after being charged in 2008 and was captured this year was sentenced today to serve 108 months in prison.

Anthony Williams, of Baton Rouge, La., was sentenced to serve 24 months in prison followed by two years of supervised release, the Justice Department, the Internal Revenue Service (IRS) and the Treasury Inspector General for Tax Administration (TIGTA) announced today.

A co-owner of a Middlesex, N.J., industrial pipes, valves and fittings supply company pleaded guilty today to one count of making a false statement.

A California investment manager was found guilty in federal district court in Salt Lake City, Utah for his role in a $33 million investment fraud scheme

A Detroit-area man was indicted today for obstruction of justice in connection with his alleged attempts to conceal evidence relevant to his upcoming trial for an alleged health care fraud scheme with estimated losses exceeding $30 million.

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

Continue reading »

The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.

Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis.

Avadel Pharmaceuticals plc's (AVDL) pivotal phase III trial evaluating FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy has met its three co-primary efficacy endpoints at all three doses.

Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space.

Organicell Regenerative Medicine Inc. (BPSR.OB) has received FDA clearance to initiate a phase I/II multi-center clinical trial of Organicell Flow in patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection.