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By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.

The Advanced Medical Association (AdvaMed) has requested the United States Trade Representative (USTR) provides additional tariff exclusions for medical devices, components and supplies coming from China which are necessary to help with Covid-19.

Mitsubishi Chemical America has entered into a definitive agreement to acquire all of the issued and outstanding shares of Gelest Intermediate Holdings, the parent of Gelest, and a portfolio company of New Mountain Capital.

AdvaMed has announced the launch of a new platform, which will attempt to connect ventilator companies with component suppliers to ensure quick scale production and distribution of these devices during the Covid-19 pandemic.

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 […]

Dr Mike England joins as medical director for UK & ROI

The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. He will assume the position on 1 January 2020.

The appointment comes after his predecessor, Mike Thompson, stepped down in June. He had served in the role since March 2016. Torbett was unanimously selected by the ABPI board after an external recruitment process with an executive search agency.

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Eli Lilly veteran Enrique Conterno has been revealed as the new Chief Executive Officer of FibroGen following the unexpected death of its previous long-term Chief Thomas Neff in August last year.

Neff passing took the company off-guard, bringing a sad and abrupt end to his 26 years of service. In the wake of the loss, FibroGen appointed Board member James Schoeneck to lead the company until a permanent replacement could be found.

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Data science firm Genomics Plc, which lays claim to “the world’s largest genomic database”, has welcomed Mitchell Harris to the company and its senior leadership team as its Chief Strategy Officer.

Joining from his previous role as Global Head, Emerging Business Lines at Abcam, Harris’ career has given him ample experience in commercial strategy and operations. Prior to his most recent role at Abcam, he acted as the company’s Head of Proteins Portfolio Commercial and Business Development.

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This week, I’m rerunning some popular posts while I prepare for today’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Click here to see the original post and comments from January 2020.

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Manufacturers recently announced list price increases for many brand-name drugs. The typical increase was about 5%. Judging by recent history, these moderately higher list prices will translate into another year of falling brand-name drug prices in 2020.

This surprising conclusion comes from our analysis of SSR Health data on prices for more than 1,000 drugs. Details below.

SSR Health data reveal that list prices for brand-name drugs rose by about 5% in 2019. However, net prices (after rebates and discounts) decreased by -3.1%. Drug makers discounted their brand-name drug list prices by an average of 45%.

Too many journalists and politicians remain committed to the false narrative of “skyrocketing drug prices.” In 2020, Congress may again take up drug price legislation. Let’s all hope that our country builds its public policies based upon accurate facts and reliable data. Hope has to triumph over experience eventually.
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WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials....

Almost half of Americans believe that the coronavirus was created in a lab, according to an April survey of 6,300 people.

President Donald Trump has vowed to cut the US’s reliance on foreign drugs, singling out China and Ireland as countries he wants to stop buying pharmaceuticals from.

Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said.

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.

Five defendants, all members or associates of an extended family, face potential life sentences after being found guilty of sex trafficking for participating in a scheme that lured young Central American women and girls into the Los Angeles area and forced them into prostitution. The defendants, four Guatemalan nationals and one Mexican citizen, were convicted on Feb. 11, 2009, of conspiracy; sex trafficking by force, fraud or coercion; and importation of aliens for purposes of prostitution.

The United States has sued a Sacramento, Calif., tax preparer, Chris Elmer, his firm – Associated Tax Planners Inc. (ATP) – and several members of his family associated with ATP, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Sacramento with the U.S. District Court for the Eastern District of California.

An Iraqi-born Dutch citizen today pleaded guilty to conspiring with others to murder Americans overseas, including by planting roadside bombs targeting U.S. soldiers in Fallujah, Iraq, and by demonstrating on video how these explosives would be detonated to destroy American vehicles and their occupants.

The Department announced today that it has entered into a consent decree with the city of Dayton that, if approved by the court, will resolve the Department’s complaint that Dayton has been engaged in a pattern or practice of discrimination against African-Americans in its hiring of entry-level police officers and firefighters, in violation of Title VII of the Civil Rights Act of 1964 (Title VII).

The Department today filed a lawsuit on behalf of David D. Sweatt, a Michigan Army National Guard member currently serving in Iraq, against Americraft Carton Inc. (Americraft), alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).

The Department has entered into a consent decree with the City of Portsmouth, Va., that, if approved by the court, will resolve the Department’s complaint that the City of Portsmouth engaged in a pattern or practice of employment discrimination against African Americans in its hiring of entry-level firefighters, in violation of Title VII of the Civil Rights Act of 1964 (Title VII).

An Iraqi-born Dutch citizen was sentenced to 25 years in prison today for conspiring to murder Americans overseas, including by planting roadside bombs targeting U.S. soldiers in Fallujah, Iraq, and by demonstrating on video how these explosives would be detonated to destroy American vehicles and their occupants.

The Department’s Antitrust Division today announced the appointment of its new leadership team including the Chief of Staff, four Deputy Assistant Attorneys General, and a Special Counsel for Competition Policy. Two Deputies will oversee civil matters, one Deputy will oversee economic analysis and one Deputy will oversee international, policy and appellate issues.

Justin Hanson, 21, of Mason City, Iowa, pleaded guilty today in federal court in Cedar Rapids to violating the civil rights of an African-American family.

The Department announced a settlement that, if approved by the court, will resolve its lawsuit filed on behalf of David D. Sweatt, a Michigan Army National Guard member currently serving in Iraq, against his former employer, Americraft Carton Inc. (Americraft).

"To ensure that the Department holds itself to the highest standards during discovery -- as in every stage of litigation -- in our criminal cases, and also in our civil litigation, we have taken both short-term and long-term action."

Special Litigation Counsel Kristy Parker, a senior attorney in the Civil Rights Division’s Criminal Section, has been selected to receive the 2009 Top Prosecutor Award from the Women in Federal Law Enforcement (WIFLE).

The U.S. Court of Appeals for the Fifth Circuit today rejected a challenge to the conviction of James Ford Seale, a former member of the White Knights of the Ku Klux Klan of Mississippi. Seale was convicted by a federal jury in Mississippi in 2007 and sentenced to three life terms in prison.

The Department announced that it has moved to intervene in a lawsuit filed in federal court in Jackson, Miss., challenging inaccessibility in Jackson’s public transportation system. The pending lawsuit, filed by 11 residents of Jackson with disabilities and two non-profit organizations that work on behalf of people with disabilities, alleges violations of the Americans with Disabilities Act and the Rehabilitation Act of 1973 (ADA).

A former executive of Philadelphia-based Nexus Technologies Inc. pleaded guilty today in connection with his participation in a conspiracy to bribe Vietnamese government officials in exchange for lucrative contracts to supply equipment and technology to Vietnamese government agencies, in violation of the Foreign Corrupt Practices Act (FCPA).

Helmerich & Payne Inc. (H&P) has entered into an agreement with the Department of Justice to resolve improper payments by H&P to government officials in Argentina and Venezuela in violation of the Foreign Corrupt Practices Act (FCPA).

“We are extremely disappointed with the Scottish Executive's decision to release Abdel Basset Mohamed al-Megrahi. The interests of justice have not been served by this decision. There is simply no justification for releasing this convicted terrorist whose actions took the lives of 270 individuals, including 189 Americans. Megrahi did not show and has not shown compassion for innocent human life, and as we communicated to the Scottish authorities and the UK government, it continues to be our position that he should have been required to serve the entire sentence handed down for his crimes. Our deepest sympathies go out to the families of those whose loved ones were killed in 1988 due to Megrahi's vicious actions.”

Former UBS banker, Bradley Birkenfeld of Weymouth, Mass., has been sentenced to 40 months incarceration by Judge William J. Zloch in Fort Lauderdale, Fla. On June 19, 2008, Birkenfeld pleaded guilty to conspiring to defraud the United States.

Three Ohio residents, Mohammad Zaki Amawi, 29, Marwan Othman El-Hindi, 46, and Wassim I. Mazloum, 28, have been sentenced to prison terms ranging from more than 8 years to 20 years for conspiring to commit terrorist acts against Americans overseas, including U.S. military personnel in Iraq, and other terrorism-related violations.

The Department said that the deal as originally proposed would substantially lessen competition in the manufacture of refinery desalters in the United States.

The lawsuit alleges that Terence Flanagan refused to rent a single-family house he owns in Orland Park, Ill., to Kamal Alex Majeid, who is African-American, because of his race.

The department announced a settlement agreement under the Americans with Disabilities Act (ADA) with Intellitec Colleges in Colorado Springs, Grand Junction, and Pueblo, Colo., to ensure access to its technical colleges for individuals with disabilities.

The Department filed a lawsuit against the state of New Jersey and the New Jersey Civil Service Commission alleging a pattern or practice of employment discrimination against African-Americans and Hispanics, in violation of Title VII of the Civil Rights Act of 1964

The Department announced separate agreements under the Americans with Disabilities Act (ADA) with Case Western Reserve University in Cleveland, Pace University in New York City and Reed College in Portland, Ore., regarding the use in a classroom setting of the electronic book reader, the Kindle DX, a hand-held technological device that simulates the experience of reading a book.

Paul Schlesselman pleaded guilty to one count of conspiracy, one count of threatening to kill and inflict bodily harm upon a presidential candidate, and one count of possessing a firearm in furtherance of a crime of violence.

The Department has reached a settlement agreement with the Alameda County, Calif., Sheriff’s Office, under which it will provide sign language interpreters and other auxiliary aids and services to arrestees, detainees, suspects, victims, witnesses, complainants and visitors who are deaf, hard of hearing or deaf-blind at two jails.

The Department said that despite the substantial progress reflected in the proposed amended settlement agreement in The Authors Guild Inc. et al. v. Google Inc., class certification, copyright and antitrust issues remain.

Without the divestitures, the department said the acquisition would lead to higher prices, lower quality, less favorable supply-chain options, reduced technical support and less innovation.

The former acting executive director of U’una’i Legal Services Corporation pleaded guilty today to stealing $31,292 from the federally-funded organization in American Samoa.

Nexus Technologies Inc., a Philadelphia-based export company, pleaded guilty today in connection with a conspiracy to bribe officials of the Vietnamese government in exchange for lucrative contracts to supply equipment and technology to Vietnamese government agencies, in violation of the Foreign Corrupt Practices Act (FCPA).

The Department announced a comprehensive settlement agreement under the Americans with Disabilities Act (ADA) with HRB Businesses of Florida Inc., to ensure effective communication with individuals who are deaf or hard of hearing in the provision of tax preparation services and courses.

The United States has reached a comprehensive settlement agreement with the city of Jackson, Miss., to improve access to public transportation for individuals with disabilities.

Daniel Cowart pleaded guilty today to eight counts in a federal indictment charging him with crimes related to a racially-motivated plot to murder dozens of people.