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 charity's Centre for Drug Development will sponsor and fund a future Phase I clinical trial for CB213

Chief Executive Mike Thompson is to retire from his role at the Association of the British Pharmaceutical Industry (ABPI) by the end of this year.

His decision to leave the association marks the end of a three-year run beginning in March 2016, when stepped in to take up the mantle from Alison Clough, who had served as the acting Chief Executive for much of 2015.

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ICYMI, the boffins at the Centers for Medicare & Medicaid Services (CMS) recently released their new projections for U.S. National Health Expenditures (NHE). Unfortunately, the coronavirus almost immediately made these predictions obsolete.

It’s still useful to analyze these forecasts for a pre-pandemic examination of U.S. healthcare spending. A few highlights of the 2024 outlook:

• Total U.S. spending on healthcare was projected to grow, from $3.6 trillion in 2018 to $5.0 trillion in 2024.

• Spending on hospitals and professional services was expected to grow by a combined $800 billion—more than 60% of CMS’s projected $1.4 trillion increase in U.S. healthcare spending. That’s consistent with historical trends.

• Net spending on outpatient prescription drugs in 2024 was projected to shrink to less than 9% of total U.S. spending. That would be its lowest level since 2000.

As usual, the actual facts run counter to the popular narrative that drug spending is skyrocketing relative to any other aspect of U.S. healthcare. Of course, the coronavirus will alter these projections. Below, I speculate how COVID-19 and its aftermath will affect healthcare and prescription drug spending.

Prediction is very difficult, especially if it's about the future. Feel free to add your own outlook in the comment section below.
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Today’s guest post comes from Trygve Anderson, Vice President of Commercial Pharmacy at Elsevier.

Trygve discusses trends and challenges to watch in 2020, including drug pricing transparency, the approval and interchangeability of biosimilars, and stakeholder access to timely and accurate data.

Learn more about Elsevier’s information analytics capabilities from its video: Evaluating Drug Data Yields Business Value.

Read on for Trygve’s insights.
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Safeguarding public health requires rethinking our relationship to the environment and the inequities that drive its destruction

-- Read more on ScientificAmerican.com

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....

Nearly half of US states will have their ‘stay-at-home’ orders expire this week, paving the way for much of the US to relax its lockdowns.

A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.

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.

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.

Click to view a price quote on AGN.

As you may know, I maintain an extensive list of book recommendations for the biotech enthusiast on a "Amazon Influencer" page. After the latest update there are well over 100 titles! I recently analyzed the data to come up with the most popular titles among my followers (perhaps the full list is a bit intimidating):​Genentech: The Birth of BiotechThe Biotech Trader HandbookThe Pharmagellan Guide to Biotech Forecasting & ValuationValuation in Life Sciences: A Practical GuideThe Antidot [...]

Hassan Saied Keshari and his corporation, Kesh Air International, pleaded guilty this morning in the Southern District of Florida to charges of conspiring to illegally export military and commercial aircraft parts to Iran. 

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.

Jimmy “Jimbo” Sullivan, the former chief of police in Mendenhall, Miss., pleaded guilty today to a felony civil rights violation, admitting that he used excessive force when he repeatedly stomped on the head of an arrestee.

Two Florida homeland security vendor employees were sentenced today for conspiracy to commit wire fraud and honest services fraud by depriving their employers of money and the right of honest services, the Department of Justice announced today.

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.

Kentucky Utilities (KU), a coal-fired electric utility, has agreed to pay a $1.4 million civil penalty and spend approximately $135 million on pollution controls to resolve violations of the Clean Air Act.

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.

Five U.S. defendants convicted for their activity in a global child pornography trafficking enterprise were sentenced today in the Northern District of Florida. The defendants had pled to multiple charges, including engaging in a child exploitation enterprise; conspiracy to advertise, transport, ship, receive and possess child pornography; advertising child pornography; transporting child pornography; and receiving child pornography.

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.

The city of Independence, Mo., has agreed to make major improvements to its sanitary sewer system, at an estimated cost of more than $35 million, to eliminate unauthorized overflows of untreated sewage into the Missouri River each year. Under the terms of the consent decree, lodged in Kansas City, Mo., Independence will also pay a civil penalty of $255,000 and will spend an additional $450,000 on supplemental environmental projects designed to enhance Missouri River watershed by improving storm water detention basins and stabilizing stream banks.

Traian Bujduveanu has pleaded guilty in the Southern District of Florida to a charge of conspiring to illegally export military and dual use aircraft parts to Iran. Bujduveanu appeared on behalf of himself and his now defunct corporation, Orion Aviation, in federal court in Miami today to announce his guilty plea.

Three defendants were sentenced to prison today after pleading guilty in January 2008 to federal charges of running an “advance-fee” scheme that targeted U.S. victims with promises of millions of dollars.

The Justice Department today announced the filing of a lawsuit and the settlement of its claims against Fort Bend County, Texas, alleging violations of the Voting Rights Act of 1965, as amended, and the Help America Vote Act (HAVA).

WASHINGTON and PENSACOLA, Fla. – Six U.S. defendants convicted for their activity in a global child pornography trafficking enterprise were sentenced today in the Northern District of Florida, Acting Assistant Attorney General of the Criminal Division Rita M. Glavin, U.S. Attorney for the Northern District of Florida Thomas F. Kirwin and FBI Executive Assistant Director J. Stephen Tidwell announced.

A federal judge today sentenced Jimmy “Jimbo” Sullivan, the former chief of police in Mendenhall, Miss., to 30 months in prison for using excessive force when he repeatedly stomped on the head of an arrestee. At his guilty plea hearing on Jan. 30, 2009, Sullivan admitted that he used excessive force on July 22, 2005, after joining other law enforcement officials in the apprehension of a man who led police on a car chase.

James Freeman of Santa Rosa Beach, Fla., was sentenced to life in prison today for his activity in a global child pornography trafficking enterprise. Freeman, a registered sex offender, was found guilty following a six-day trial in January 2009 of six counts relating to his criminal activities as a member of the child exploitation enterprise.

The remaining two men convicted of plotting to kill members of the U.S. military during an armed attack on a military base were sentenced today to federal prison terms of life for one defendant and 33 years for the other for conspiring to kill members of the U.S. military. U.S. District Judge Robert B. Kugler sentenced Mohamad Ibrahim Shnewer to a term of life in prison plus an additional, consecutive 30 years. Judge Kugler sentenced Serdar Tatar to 33 years in prison.

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 today has entered into a consent decree that, if approved by the U.S District Court in Fort Myers, Fla., will resolve its complaint against the Sheriff of Hendry County, Fla., and the Hendry County Board of County Commissioners.

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.

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.

The Department filed suit against California mortgage lender Capmark Finance Inc., charging that Capmark violated the False Claims Act by making false statements on applications for federal mortgage insurance covering residential nursing homes.

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.

Traian Bujduveanu was sentenced in Miami federal court for his role in a conspiracy to illegally export military and dual use aircraft parts to Iran.

A Tampa federal grand jury has charged a Florida man with criminal contempt of a federal court order in connection with the operation of a fraudulent vending machine business opportunity. The criminal charges form part of the government’s continued nationwide crackdown on business opportunity fraud.

The Dallas Independent School District (DISD) has agreed to settle claims that the school district violated the False Claims Act in connection with the Federal Communications Commission’s E-Rate program. Under the terms of the settlement, the DISD will relinquish more than $150 million in requests for federal funds, and will pay a total of $750,000.

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.

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.

Beazer Homes USA Inc. has agreed to pay the United States $5 million dollars, plus contingent payments of up to $48 million dollars to be shared with victimized private homeowners, to resolve allegations that it, and Beazer Mortgage Corp., were involved in fraudulent mortgage origination activities in connection with federally insured mortgages.

Endoscopic Technologies Inc. (Estech), a medical device manufacturer, has agreed to pay the United States $1.4 million to resolve civil claims in connection with the alleged promotion of its surgical ablation devices. Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.

Warren Mumpower of Spokane, Wash., was sentenced to life in prison today for his activity in a global child pornography trafficking enterprise.

The Justice Department today announced an agreement with the city of Wendell, Idaho, to improve access to all aspects of civic life for persons with disabilities. The agreement was reached under the Department’s Project Civic Access initiative, which aims to bring state and local governments into compliance with the Americans with Disabilities Act (ADA).

Miami physician Keith Russell, 65, and physician’s assistant Jorge Luis Pacheco, 50, were each sentenced to 97 months in prison, and physician’s assistant Eda Marietta Milanes, 43, was sentenced to 63 months in prison, for their roles in fraud schemes that involved billing Medicare for $10,903,509 worth of unnecessary HIV infusion treatments.