uBiome, a San Francisco startup that sells commercial tests that use DNA sequencing to identify what microbes are in a person's stool or, for one test, in the vagina, has raised $83 million from venture capitalists to fund an entrée into drug development.

The pharmaceutical analysis firm is continuing its contract analytical laboratory services running, with changes designed to keep people and products safe.

First, let me say thank you to all of the healthcare workers who are putting themselves at risk during this crisis.

As I noted last week, many of the crucial issues for our healthcare system will remain after we all get through this challenging period. In that regard, here’s a look at some noteworthy news from the past month:

• Sanofi discloses new data about insulin prices

• Excellent new academic research on list vs. net drug prices

• Three notable researchers overturn their earlier research on drug costs

• Amazon switches PBM vendors for some of its employees

Plus, we unveil the teaser trailer for Drug Channels Video!

P.S. Join the more than 9,000 followers of my daily links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted such topics as:

• How GoodRx shares patients’ prescription data
• 2019 drug trend at Prime Therapeutics
• Controversy about the independent pharmacy market
• A new $5 generic mail order program, Medicare Part D reform
• Retail pharmacy’s future
• Job openings at Amazon 
• Frozen cookie dough
• And much more!

I have also been tweeting many under-the-radar stories about how the coronavirus affects drug channels.
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This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

I suspect this deal will remain profitable for the participating companies even as COVID-19 alters the US. prescription payer mix. Click here to see the original post and comments from January 2020. National market shares for the largest PBMs in 2019 appears as Exhibit 88 of our 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.

P.S. Sorry that today's meme is one day too late for Star Wars day.

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Just before the holidays, Cigna’s Express Scripts business announced a market-changing deal with Prime Therapeutics. Click here to read the press release.

There's been very little written about this transaction, though it has potentially major implications. Below, I share my thoughts on the following topics arising from the deal:

• Implications for manufacturers and pharmacies

• The role of the secretive Ascent Health Services

• What this all means for Walgreens

• Why the Federal Trade Commission won’t challenge the deal

A few weeks ago, I explained why integrated insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels. The Express Scripts / Prime deal signals that the channel will continue its amazing pace of reinvention.

The scale, scope, and interconnectedness of today’s market participants make the system increasingly resistant to massive disruption from either external players like Amazon or a government takeover. Like it or not, the channel will continue to gain power and extract profit. Read on and see if you agree.
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This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Today's rerun highlights one of the most effective tactics that PBMs have developed to extract deeper discounts from brand-name drug makers. COVID-19 seems likely shift the U.S. payer mix away from commercial health plans. Expect even tighter formulary management and more restrictions as PBMs work even harder to cut costs for their plan sponsor clients.

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

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For 2020, the two largest pharmacy benefit managers (PBMs)—Express Scripts and the Caremark business of CVS Health—have again increased the number of drugs they have excluded from their standard formularies. The 2020 formulary exclusion lists are available below for your downloading pleasure.

Below, I highlight my key takeaways from the 2020 lists:

• The number of exclusions

• Management of specialty drugs

• Indication-based formularies

• The slow adoption of biosimilars

• The PBMs’ patient-unfriendly exclusions in the hepatitis C category

Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are therefore a key factor behind falling brand-name net drug prices.

Read on for a look at this year’s exclusions along with some closing thoughts on what exclusions mean for patients.
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Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of...

WASHINGTON – November 14, 2017 – As the Senate begins debate on a tax reform bill, the clinical research industry hopes that...

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected John Ratliff, CEO of Covance Drug...

In May of 2017 the Board of Directors of the Association of Clinical Research Organizations, which represents the world’s leading clinical research...

ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers Clinical trials have an enormous number of inter-related,...

What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto...

Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Dr. Cynthia Verst,...

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

The Association of Clinical Research Organizations (ACRO) is pleased to announce the expansion of its membership to include ERT, Oracle and Veeva. These new ACRO member companies, with their focus on digital technologies that enable global clinical trials, characterize the ongoing innovation and evolution of contemporary clinical research. ACRO now has 12 member companies.

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.

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development...

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...

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 South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.

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

Researchers studying malaria in Kenya have discovered a microbe that blocks transmission of malaria from mosquitoes which could pave the way to eradicating the disease.

Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based…

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…

A federal jury in Jacksonville, Fla., found Paul Tillis, a former Florida Department of Corrections officer, guilty on Jan. 16, 2009, of a felony federal civil rights violation for an August 2005 assault on an inmate.

Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats.

Brian Carranza, 21, pleaded guilty today before U.S. District Court Judge Carol B. Amon in Brooklyn, N.Y., to conspiring to assault African-American residents in Staten Island, N.Y., in retaliation for President Barack Obama winning last year’s presidential election.

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 a settlement resolving allegations that the Metropolitan Government of Nashville and Davidson County (Metropolitan Government) violated the Fair Housing Act (FHA) and the Religious Land Use and Institutionalized Persons Act (RLUIPA) by discriminating against Teen Challenge, a Christian substance abuse treatment program.

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.

The Department announced today that it has entered into a settlement agreement with the Washington Metropolitan Area Transit Authority (WMATA) that, if approved by the court, will resolve the complaint of pattern or practice religious discrimination filed by the United States against WMATA under Title VII of the Civil Rights Act of 1964.

Kellogg Brown & Root LLC (KBR), a global engineering, construction and services company based in Houston, pleaded guilty today to charges related to the Foreign Corrupt Practices Act (FCPA) for its participation in a decade-long scheme to bribe Nigerian government officials to obtain engineering, procurement and construction (EPC) contracts. The EPC contracts to build liquefied natural gas (LNG) facilities on Bonny Island, Nigeria, were valued at more than $6 billion.

Tai Khiem Tran, 47, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat casinos across the United States and Canada. Tran admitted that he and his co-conspirators unlawfully obtained up to $1 million during card cheats.

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.

RE/MAX East-West, a real estate firm in Elmhurst, Ill., and one of its former real estate agents, John DeJohn, have agreed to pay $120,000 to settle allegations that they illegally steered prospective homebuyers toward and away from certain neighborhoods based on race and national origin. The consent decree was signed on Feb. 17, 2009, by U.S. District Judge Ruben Castillo.

The Department of Justice today filed a lawsuit against the Board of Education of the City of Chicago (Board), alleging pregnancy discrimination in employment against former elementary school teacher Traci Meziere.

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.

Gary Moss and Devan Klausegger of Medford, Ore., pleaded guilty today to conspiring to interfere with civil rights. According to facts stipulated in their plea agreements and set forth in the indictment, on May 26, 2008, Moss poured a flammable liquid on the front lawn of the victims’ residence in the shape of a cross and the letters “KKK”.

The Department announced today that it has reached a settlement that, if approved by the court, will resolve a lawsuit filed by the Department against the Administrative Office of the Courts of the State of North Carolina and the Honorable Jerry Braswell, Senior Resident Superior Court Judge for North Carolina Judicial District 8-B, in his official capacity.

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 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).

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.

Two citizens of the United Kingdom have been charged in an indictment unsealed today in the United States for their alleged participation in a decade-long scheme to bribe Nigerian government officials to obtain engineering, procurement and construction (EPC) contracts. The EPC contracts to build liquefied natural gas (LNG) facilities on Bonny Island, Nigeria, were valued at more than $6 billion.

The 60th felony conviction from Operation Fastlink, a major Department of Justice initiative to combat online piracy worldwide. Bryan Thomas Black, 30, of Waterloo, Ill., pleaded guilty today to one count of conspiracy to commit criminal infringement of a copyright for his involvement in a multinational software piracy organization that was targeted by investigators as part of “Operation Fastlink,” an internationally coordinated 18-month investigation.

An indictment was unsealed today charging Clark Alan Roberts, 46, and Sean Edward Howley, 38, both engineers with Wyko Tire Technology Inc., located in Greenback, Tenn., with conspiring to steal trade secrets from the Goodyear Tire and Rubber Company and scheming to defraud Goodyear of confidential and proprietary information.

Holy House Shipping AB, a Swedish corporation, was sentenced today in U.S. District Court in Camden, N.J., to pay a $1 million fine, a special assessment of $400,000 in community service payments and serve three years of probation for failing to maintain an accurate oil record book in an attempt to conceal illegal discharges of oil-contaminated waste directly into the ocean from one of its ships.

Building upon the successes of earlier efforts, the Department today announced the opening in Bangkok of a regional conference of approximately 100 key law enforcement and industry officials from more than a dozen nations with the goal of strengthening international cooperation in fighting large-scale intellectual property crimes.