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 […]

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 […]

Virtually unknown just a few months ago, the COVID-19 pandemic has already resulted in over 239,000 deaths worldwide—including over 67,000 in the United States alone. Now, emerging reports suggest that as many as one third of patients with severe COVID-19 infection requiring intensive care may also be battling another life-threatening infection: invasive aspergillosis, a deadly […]

RESCHEDULED: This event has been rescheduled for November 11-13, 2020. Click here to learn more.

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Informa Connect-CBI’s Patient Support Services Congress
June 16-18, 2020 | The Westin Princeton at Forrestal Village | Princeton, NJ
www.informaconnect.com/patient-support-services-congress

Informa Connect-CBI’s Patient Support Services Congress is a comprehensive meeting for insightful and engaging dialogue around navigating compliance hurdles while strengthening and innovating patient-oriented programs.

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

Download the agenda here and see in-depth coverage on industry trends and next-generation patient services, such as:

• Critical Regulatory Updates and Effective Strategies for Monitoring & Oversight
• Novel Approaches to Services, Program Architecture and Operational Management
• The pros and cons of different support service models
• Measuring the Success of Patient Support Programs
• Innovation, AI, Changing Distribution Models and Market Mergers
• Transparency with Charitable Organizations

Create Your Own Customized Learning Experience for 2020!

Choose from Two In-Depth Tracks

• Legal and Compliance
• Innovation and Operations

Plus! Four Tailored Summits

• Summit A: Patient Adherence – Educate, Engage and Collaborate to Enhance Outcomes
• Summit B: Case Management for Novel and Innovative Therapies
• Summit C: Strategic Planning for Product Launch
• Summit D: Primer Course for Partnering with Patients

Leading Perspectives from Industry Trendsetters:

• Robert Britting, Director, Patient Services and Strategic Solutions, Teva Pharmaceuticals
• Stella Vnook, Chief Executive Officer, Diverse Biotech
• Katherine Chaurette, Vice President healthcare Law and Compliance, Blueprint Medicines
• Kimberly Goldberg, Director, U.S Data Privacy Counsel, Novartis
• Imtiaz Hussain, Senior Director, Patient Services, Bayer
• Cory Potomis, Associate Director, Ethics & Compliance Operations, Novo Nordisk, Inc.
• And so many more!

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

*Offer applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Offer not valid on workshop only or academic/non-profit registrations.

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The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.

Pharmacists will be allowed to give out medication to patients who have already been receiving it

Pharmacists are to be allowed to hand out a range of super-strength medicines, including the heroin substitute methadone, without prescription during the Covid-19 crisis, under emergency measures that official drug policy advisers have warned could trigger a spike in drug misuse.

The Advisory Council for Misuse of Drugs (ACMD), which makes recommendations to the government on the control of dangerous drugs, was asked by the home secretary to consider the risks of lifting restrictions on certain substances controlled under the Misuse of Drugs Act.

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The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.

Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,…

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. 

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.

An employee of a Sewell, N.J., company that provided temporary electrical utilities pleaded guilty today to participating in a fraud conspiracy at an Environmental Protection Agency (EPA)-designated Superfund site in New Jersey.

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.

An Iranian citizen and his Tehran business have been charged with purchasing helicopter engines and advanced aerial cameras for fighter bombers from U.S. firms and illegally exporting them to Iran using companies in Malaysia, Ireland and the Netherlands. Among the alleged recipients of these U.S. goods was an Iranian military firm that has since been designated by the United States for being owned or controlled by entities involved in Iran’s nuclear and ballistic missile program.

An Irish trading company and three of its officers have been charged with purchasing helicopter engines and other aircraft components from U.S. firms and illegally exporting them to Iran using companies in Malaysia and the United Arab Emirates. Among the alleged recipients of these U.S. goods was an Iranian military firm that has since been designated by the United States for being owned or controlled by entities involved in Iran’s nuclear and ballistic missile program.

A 32-year-old Colombian citizen, Luz Mery Gutierrez Vergara, who was extradited from the Republic of Colombia on Thursday, made her initial appearance today in federal court in Washington, D.C., to face charges for allegedly participating in a conspiracy to provide material support to the Fuerzas Armadas Revolucionarias de Colombia, commonly known as the “FARC.”

Christopher Neil Gauntt, the former supervisor of the Fort Gibson Water Treatment Plant in Fort Gibson, Okla., pleaded guilty today in U.S. District Court in Muskogee, Okla., to falsifying a monthly operating report that certified the safety of drinking water from the facility.

The United States has intervened in a civil lawsuit against two former suppliers to the National School Lunch Program – Hallmark Meat Packing Company and Westland Meat Company Inc. – for submitting false and fraudulent claims to the Agricultural Marketing Service (AMS), a division of the U.S. Department of Agriculture (USDA). All ground beef containing defendants’ products was recalled by USDA as of Feb. 16, 2008, and defendants no longer supply beef to the National School Lunch Program or AMS.

Georgia-Pacific, a manufacturing company headquartered in Atlanta, has agreed to perform remedial work at an estimated cost of nearly $13 million to contain two former disposal areas within the Kalamazoo River Superfund site in Allegan and Kalamazoo Counties, Mich.

Mohammed Abdullah Warsame, a 35-year-old resident of Minneapolis, has pleaded guilty to one count of conspiring to provide material support and resources to al-Qaeda.

Thirty-six companies allegedly responsible for hazardous contamination of soil and groundwater at the Breslube-Penn Superfund Site in Coraopolis, Pa., have agreed to cleanup up the site. According to the settlement filed in U.S. District Court in the Western District of Pennsylvania, the companies have agreed to fund and/or complete a $12 million cleanup at the seven-acre site.

A Grand Rapids, Mich., grand jury returned a two-count indictment charging a former school superintendent with engaging in a conspiracy to accept a bribe from a vendor and to deprive his former employer and the citizens of Michigan of his honest services in connection with the Federal Communications Commission’s (FCC) E-Rate Program.

After a bench trial held last week in the Northern District of Georgia, U.S. District Judge William S. Duffey, Jr., announced today that Syed Haris Ahmed, 24, has been found guilty of conspiracy to provide material support to terrorists.

The city of Duluth, Minn., and the Western Lake Superior Sanitary District have agreed to make improvements to the area’s sewer system, estimated to cost about $130 million, to eliminate sanitary sewer overflows in an agreement filed today in U.S. District Court in Minneapolis, Minn.

Herbert L. Corn, the former superintendent of the city of Rochester Wastewater Treatment Plant in Rochester, Ind., pleaded guilty today in U.S. District Court in South Bend, Ind., to falsifying monthly discharge monitoring reports that concealed violations of the Clean Water Act at the Rochester plant.

Additional charges and defendants have been added to a federal case arising from the abduction of a boy from his Las Vegas home in October 2008.

A former executive of Bennett Environmental Inc. (BEI), a Canadian-based company that treats and disposes of contaminated soil, pleaded guilty to participating in a conspiracy to pay kickbacks and commit fraud at the U.S. Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J. The former executive also pleaded guilty to participating in a money laundering conspiracy and impeding a proceeding before the U.S. Securities and Exchange Commission.

A 35-year-old Minneapolis man was sentenced today in federal court on one count of conspiring to provide material support and resources to al-Qaeda. In Minneapolis, U.S. District Court Judge John Tunheim sentenced Mohammed Abdullah Warsame to 92 months in prison and three years of supervised release.

Attorney General Eric Holder today announced more than $8.7 million in Recovery Act funds for three communities in California to use in fighting crime and drug trafficking as part of the Justice Department’s Southwest Border Strategy.

A federal jury in Los Angeles convicted the owners and operators of a Los Angeles-area durable medical equipment company of Medicare fraud. After a one-week trial in federal court in Los Angeles, the jury found Gevork Kartashyan, 45, guilty of conspiracy to commit health care fraud and health care fraud; and Eliza Shurabalyan, 42, guilty of health care fraud. U.S. District Judge Stephen V. Wilson of the Central District of Los Angeles scheduled sentencing for Oct. 5, 2009.

A federal jury has found Ehsanul Islam Sadequee, 23, of Roswell, Ga., guilty on all four counts of an indictment charging him with supporting terrorists and a foreign terrorist organization, after a trial that lasted seven days.

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.

Jacques Monsieur, a Belgian national and resident of France suspected of international arms dealing for decades, has been arrested on charges alleging that he conspired to illegally export F-5 fighter jet engines and parts from the United States to Iran.

A Newark grand jury indicted three individuals for their participation in fraud and kickback conspiracies related to contracts at a U.S. Environmental Protection Agency (EPA)-designated Superfund site, Federal Creosote, located in Manville, N.J.

The former superintendent of a wastewater treatment facility in Rochester, Ind., was sentenced today in U.S. District Court in South Bend, Ind., to serve one year in prison for falsifying discharge monitoring reports that concealed violations of the Clean Water Act.

Today, a federal grand jury returned a superseding criminal indictment in the Daniel Patrick Boyd matter. While the superseding indictment returned today includes all of the charges alleged in the original indictment of July 22, 2009, it also includes new charges against three defendants, Daniel Patrick Boyd, aka "Saifullah," Hysen Sherifi, and Zakariya Boyd, aka "Zak."

A federal grand jury in Oklahoma City returned a superseding indictment against a former manager of a U.S. Department of Defense (DOD) contractor in Iraq, charging him with conspiracy to commit bribery, bribery and failing to appear in court.

“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.

James E. Haas Jr. pleaded guilty in the U.S. District Court of New Jersey, to charges that he engaged in a kickback and fraud conspiracy at the Federal Creosote Superfund site in Manville, N.J.

Noel Wayne Jhagroo, 47, pleaded guilty to conspiracy to commit health care fraud before U.S. District Judge Vanessa Gilmore in the U.S. District Court in Houston. 

Two companies and the city of St. Maries, Idaho, have agreed to clean up a superfund site in St. Maries at a cost estimated more than $12 million.

The lawsuit, which was filed in the U.S. District Court for the Northern District of Georgia, alleges that since 2003, defendants have violated the False Claims Act.

Kristine Lafoe was sentenced to serve one year in prison and two years of supervised release for her role in covering up systematic detainee abuse.

Jacques Monsieur, a Belgian national and resident of France suspected of international arms dealing for decades, pleaded guilty today in U.S. District Court for the Southern District of Alabama to conspiracy to illegally export F-5 fighter jet engines and parts from the Untied States to Iran.

Ten individuals were indicted today, charged with, among other things, conspiring to export weapons from Philadelphia to the Port of Latakia, Syria.

John L. Cockerham, 43, a major in the U.S. Army, was sentenced to 210 months in prison.

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.

A settlement estimated worth more than $30 million will ensure that cleanup of the Sutton Brook Disposal Area Superfund Site in Tewksbury, Mass., will move forward, the Justice Department and U.S. Environmental Protection Agency and the Massachusetts Department of Environmental Protection announced today.

Manual Deluna has pleaded guilty to one count of conspiracy to commit health care fraud in connection with his role in Memorial Medical Supply, a Houston durable medical equipment company.

Former military contractor Terry Hall, 43, of Snellville, Ga., pleaded guilty today to conspiracy to pay more than $3 million in bribes to U.S. Army contracting officials stationed at Camp Arifjan, an Army base in Kuwait, and to money laundering conspiracy.

Among other things, Zazi admitted that he brought TATP [Triacetone Triperoxide] explosives to New York on Sept. 10, 2009, as part of plan to attack the New York subway system.