Lumos Pharma, Inc. has promoted Dr John McKew to the position of Chief Operating Officer effective 1 April 2020.

McKew is already Chief Scientific Officer and he will do both roles simultaneously. With his new role, he will lead Lumos’s clinical development plan as the company looks toward adding additional assets to its pipeline.

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These policies restricting abortion are unlikely to conserve PPE, and more importantly, they mischaracterize the nature and importance of abortions.

The post The Harms of Abortion Restrictions During the COVID-19 Pandemic appeared first on Bill of Health.

Topics include off-label and compassionate drug use for COVID-19 and utilization and cost of naloxone for patients at high risk of opioid overdose.

The post Monthly Round-Up of What to Read on Pharma Law and Policy appeared first on Bill of Health.

Miami’s Phillip Frost, who built a $2.8 billion fortune in the generic drug business, was allegedly involved in a tawdry stock promotion scheme, the Securities and Exchange Commission says.

The company has incorporated electronic trial master file document storage capabilities to its Engility clinical trial management platform.

I am pleased to announce our new 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, available for purchase and immediate download.

• Click here to download a free report overview (including the Table of Contents and a List of Exhibits)

• Pharmacy Industry Revenues Hit Record High—Amid Profit Pressures and Amazon Threat, Says New Drug Channels Institute Study (press release)

We’re offering special discounted pricing if you order before March 22, 2020.

The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers is a truly unique resource. With 203 proprietary charts, exhibits, and data tables, this 11th edition provides a comprehensive, fact-based, and non-partisan tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system.

The full document clocks in at 374 pages. I can safely say there is nothing else available that comes close to this report.

The chart below illustrates the depth and breadth of the 2020 edition. The numbers indicate the report chapter that corresponds to, explains, and analyzes each channel flow.


Below, you can read more info and some behind-the-scenes tidbits.

P.S. If you would like to pay by corporate purchase order or check, please email Tamra Feldman. If you preordered the report, you should have already received an email with download instructions. Please contact us if you did not receive the email.
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I hope you are staying healthy and are managing to navigate your work-at-home mandates.

Last week, I tapped the collective insights of the Drug Channels’ audience. Nearly 700 readers shared their perspectives and projections for how the coronavirus pandemic could ultimately affect behavior, policy, and industry structure. Thank you to everyone who took the time to respond.

I will share the results over three articles this week:

• Today, in Part 1, I will review the responses relating to patient behavior, pharmacies, and wholesalers. 
• In Part 2 (tomorrow), I’ll focus on expectations for pharmaceutical manufacturers and third-party payment. 
• In Part 3 (Thursday), I’ll examine how the coronavirus may affect the public perception of the industry’s participants.

P.S. A special shout out to the respondent who hoped that the coronavirus would not impact the quality of Drug Channels memes. Never fear, dear readers: Drug Channels will remain the internet’s top destination for pharmaceutical-related humor!
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The U.S. economy is in a medically-induced coma. Unemployment is soaring. Companies are teetering on the brink of bankruptcy. It is unclear when our lives will return to their pre-pandemic state.

One thing seems apparent: As people lose jobs and health insurance, Medicaid enrollment will jump, perhaps by as much as 20% to 30%. This will have profound implications for the drug channel.

Today, I focus on how this increase will affect retail pharmacies and pharmacy benefit managers (PBMs). Below, I review Medicaid enrollment trends, how states manage prescriptions, and the factors driving the coming boom in Medicaid enrollment.

As I explain, many (but not all) retail pharmacies will benefit from Medicaid growth. PBMs, however, will not fare as well. Read on and see if you agree.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

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In Drug Channels Institute's list of the top 15 pharmacies of 2019, we show that many of the largest U.S. pharmacies are now central-fill mail and specialty pharmacies operated by PBMs and insurers.

To complement that broader ranking, we present below our exclusive list of the top 15 pharmacies based on specialty drug dispensing revenues. Consistent with our previous analyses, PBMs and insurers have retained their dominance over specialty drug channels, while smaller pharmacies are facing increased competition and profit pressures.

I see upside for specialty pharmacies in the aftermath of the pandemic. This growth will come at the expense of provider-administered drug channels. I expect the top companies’ share will increase in 2020, due to mergers and business transitions among the largest PBMs. However, the increasing role of government payers may create opportunities for smaller pharmacies.

This Friday, I’ll discuss how COVID-19 will affect the specialty pharmacy market during the first of my two live video webinars.

Over the next two weeks, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. Contact Paula Fein (paula@drugchannelsinstitute.com) for our special promo codes for multiple viewing sites. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

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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.

Life was very different when I originally published today’s article. 2020 is not turning out to be quite what any of us expected. However, the pandemic has exposed some intriguing pros and cons of vertical consolidation. Click here to see the original post and comments from December 2019.

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The largest insurers, PBMs, and specialty pharmacies have now combined into vertically-integrated organizations. As I explain below, these companies have also been rapidly integrating with healthcare providers.

I also provide an updated look at these companies and highlight strategies that they are using—or could use—to control the channel. I believe that these insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels by exerting greater control over patient access, sites of care/dispensing, and pricing.

If they can effectively coordinate their sprawling business operations, they will pose a substantial threat of disruption to the existing commercial strategies of pharma companies.

Will they succeed by better managing care and costs, or merely by extracting higher profits from our convoluted system?
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Higher temperatures and wetter weather may spur soil microbes to release more carbon into the atmosphere

-- Read more on ScientificAmerican.com

COVID-19 continues to dominate the news cycle as we all try to maintain business as usual under the shadow of the pandemic. Just about every area of society and business has been hit and Life Sciences is no exception; the impact of the virus has been felt in every corner of the industry and our monthly issues aim to cut through the confusion to shed a light on that impact.

Hydroxychloroquine continues to feature in coronavirus news. Rick Bright, the Director of BARDA, alleges he was pushed out of his position due to his pushback to the administration focusing on the use of hydroxychloroquine in COVID-19 patients. This came after the National Institutes of Health said coronavirus patients should not take the drug due to potential “toxicities.”

The search for a COVID-19 treatment has ramped up this week, with two new studies detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with coronavirus, while researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential drug to help alleviate symptoms of the virus.

A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the pandemic disease.

Vaccines and treatments for COVID-19 continue to dominate the news, as two studies reveal "positive" data for Gilead's remdesivir in hospitalised coronavirus patients while Lonza and Moderna have entered an agreement to mass produce a vaccine.

Alexion has announced it is to acquire Boston-based blood disorder specialist Portola Pharmaceuticals in a transaction to the value of $1.41 billion in cash.

Danish drugmaker Acesion Pharma, which is focused on novel treatments for atrial fibrillation (AF), has…

Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…

In another strategic M&A deal announced so far this month, PTC Therapeutics has entered into an agreement…

Canada-based BetterLife Pharma, previously known as Pivot Pharmaceuticals, has entered into an agreement…

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.

The owner and operator of HME Solutions Inc., dba Lifecare Medical (Lifecare Medical), a licensed pharmaceutical wholesale company in Miami, pleaded guilty today to defrauding the Medicare program in connection with a $5.3 million HIV-infusion fraud scheme.

The Department today filed a lawsuit on behalf of Suzanne L. Halverson, an Army National Guard member, against Grand Forks County, N.D., alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), which prohibits employers from discriminating against service-members because of their past, current or future military service obligations.

A federal jury in Memphis, Tenn., today found Arthur Sease IV, a former Memphis Police Department officer, guilty on forty-four counts of civil rights, narcotics, robbery and firearms offenses. The evidence at trial showed that from November 2003 through April 2006, Sease conspired with other Memphis police officers to use their authority as law enforcement officers, including their service weapons, to rob suspected drug dealers of cash, cocaine and marijuana. Sease and his co-conspirators would then resell the stolen drugs for their own profit.

A former member of the U.S. armed services pleaded guilty today in the U.S. District Court for the District of Arizona in Tucson for his role in a widespread bribery and extortion conspiracy. The charges arise from Operation Lively Green, an undercover investigation conducted by the FBI that began in December 2001. To date, 56 additional defendants have been sentenced for their roles in the conspiracy.

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.

The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs. At the same time, KV agreed to the injunction in a consent decree.

The Department announced today that it has entered into a consent decree with Ecolab Inc. (Ecolab) that will resolve the Department’s complaint, which was filed today, that Ecolab failed to reemploy Michigan veteran Stephen Alasin in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994, as amended (USERRA). The consent decree was approved by the court today as well.

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 today filed a lawsuit in U.S. District Court in Indianapolis on behalf of Mathew B. Jeffries, an Indiana National Guard member, against the Indianapolis law firm of Mike Norris & Associates, alleging that the law firm refused to promptly reemploy Jeffries in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).

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 Department today filed a lawsuit in U.S. District Court in Philadelphia on behalf of Frantz Julien, a New York Army National Guard member, against the Symphony Diagnostic Services Inc., doing business as MobilexUSA (Mobilex), alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).

A former contract employee of the U.S. Army Corps of Engineers and a dirt, sand and gravel subcontractor were both convicted on charges of conspiracy and bribery in connection with a $16 million hurricane protection project for the reconstruction of the Lake Cataouatche Levee, south of New Orleans.

The Department has reached a settlement that will resolve its lawsuit filed against Grand Forks County, N.D., on behalf of Suzanne L. Halverson in accordance with the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), if approved by the U.S. District Court in Fargo. USERRA prohibits employment discrimination against individuals because of their service in the uniformed services.

A federal grand jury returned an indictment today charging Robert Jeffery, 55, with conspiracy and theft of government property in connection with a scheme to steal large quantities of fuel from the U.S. Army in Iraq.

The Department today has reached a settlement that, if approved by the U.S. District Court in Philadelphia, will resolve its lawsuit filed on behalf of Frantz Julien against Symphony Diagnostic Services Inc., doing business as MobilexUSA (Mobilex).

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).

U.S. District Judge Deborah K. Chasanow today sentenced Victor Ramirez, a/k/a “Mousey,” age 30, a native of El Salvador who resided in Hyattsville, Md., to 60 years in prison, followed by five years of supervised release.

A 23-count indictment unsealed today alleges that a civilian contractor paid more than $2.8 million in bribes to a U.S. Army contracting official stationed at Camp Arifjan, an Army base in Kuwait, and the official’s wife, and that the three individuals committed honest services fraud and money laundering offenses in connection with the same conduct.

Elbert Westley George III, 36, a U.S. Army captain who was stationed in Iraq, pleaded guilty today to participating in a scheme to steal U.S. government equipment and sell it to a local Iraqi businessman.

The United States and 16 states have joined in two whistleblower suits filed in the District of Massachusetts against the drug manufacturer, Wyeth, alleging that the company knowingly failed to give the government the same discounts it provided to private purchasers of its drugs, as required by laws governing the Medicaid program.

A federal grand jury returned a superseding indictment today charging Robert Young, 56, a former captain in the U.S. Army, and Robert Jeffery, 55, a former master chief petty officer in the U.S. Navy, with conspiracy and theft of government property in connection with a scheme to steal large quantities of fuel from the U.S. Army in Iraq.

Aventis Pharmaceutical Inc., a wholly owned subsidiary of sanofi-aventis U.S. LLC, has agreed to pay the United States $95.5 million to settle allegations that it violated the False Claims Act by misreporting drug prices in order to reduce its Medicaid Drug Rebate obligations. The settlement resolves allegations that between 1995 and 2000, Aventis and its corporate predecessors knowingly misreported best prices for the steroid-based anti-inflammatory nasal sprays Azmacort, Nasacort and Nasacort AQ.

The Department today filed a lawsuit against the state of Nevada and its Office of the State Controller alleging it violated the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA) by refusing to promptly reemploy Arthur Ingram when he returned from active military duty and then by firing him after he filed a USERRA complaint.

Raschad L. "Sean" Lewis, a former fuel section employee of Kellogg Brown and Root Inc. (KBR), assigned to Bagram Airfield in Afghanistan, was found guilty yesterday by a federal jury of conspiracy, false writing, bribery of a public official, and false claims stemming from a bribery and a fuel diversion scheme.

"Keeping guns out of the hands of the Mexican drug warlords is a top priority for the Department. It is a priority that the President and the Attorney General have promised to address quickly and aggressively."

John Reece Roth, 72, of Knoxville, Tenn., was sentenced to 48 months in prison for violating the Arms Export Control Act by conspiring to illegally export, and actually exporting, technical information relating to a U.S. Air Force (USAF) research and development contract.

Arthur Sease IV, a former Memphis Police Department officer, was sentenced today to a prison term of life plus 255 years by Chief Judge Jon P. McCalla in Memphis, Tenn. A jury convicted Sease in February 2009 of 44 counts of civil rights, narcotics, robbery, and firearms offenses.

Robert Young, 56, a former captain in the U.S. Army, pleaded guilty today to participating in a scheme to steal fuel worth approximately $39.6 million from the U.S. Army in Iraq.