Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.

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

CAS, a division of the American Chemical Society, has released a dataset of chemical compounds with known or potential antiviral capabilities.

The agency continues to offer guidance about COVID-19 treatments and testsâand issue warnings to companies that fall out of line.

The group will work to rapidly develop guidance on standardizing COVID-19 research data, with the help of several participating member companies.

Led by Medable, the multi-company effort is geared toward ramping up development of treatments, diagnostics and other solutions for the pandemic-causing virus.

The companyâs global analysis from thousands of studies and sites indicates dramatic shifts in enrollment across several countries since the pandemic began.

The agency continues to remain busy overseeing and approving potential treatments and tests for the virus behind the global pandemic.

Informa Connect-CBI’s 22nd Annual Medicaid and Government Pricing Congress
May 19-21, 2020 | Orlando, FL
www.cbinet.com/medicaidandgovernment

Exclusive Offer: Register by April 10th and save $500* (mention promo code MDCDC5).

With a volatile healthcare system combined with an election year upon us, the stakes are incredibly high for life sciences manufacturers. Staying on the pulse of industry trends, policies and regulations has never been more critical. The 22nd Annual Medicaid and Government Pricing Congress delivers critical updates and industry best practices to effectively contract, report and comply with state and federal healthcare programs. Gain timely, up-to-the-minute insights on:

• State Invoicing and Disputes
• GTN Models
• Innovative Contracting Strategies
• State Price Transparency and Reporting Requirements
• 340B Oversight and Compliance
• Preparing, Negotiating and Implementing FSS Contracts
• Bona Fide Service Fees and FMV
• And many other critical topics

Download the complete program agenda.

The 2020 agenda features 75+ speakers and 50+ sessions customizable by company type and size, as well as 10 hours of dedicated networking. Bio/pharma, regulatory and government experts representing HHS, Pfizer, Daiichi Sankyo, Sobi, Maryland Department of Health, BMS, Jazz, Novartis, Amneal, J&J, Sunovion, Gilead, VA, Granard, Insmed, UCB, Alnylam, Louisiana Department of Health, AstraZeneca, CMS, CSL Behring, Astellas, Lilly, Oklahoma Healthcare Authority, Theravance, Indivior, Sandoz, Alvogen, Takeda, OIG, AMAG, Aimmune, Exelixis, South Dakota Department of Healthcare Services, Regeneron, Sun Pharma, Teva and many others are set to drive the dynamic dialogue.

Drug Channels readers can register today and use promo code MDCDC5 to save $500.

*Discount offer valid through 4/10/2020; applies to standard rates only and may not be combined with other offers, categories, promotions or applied to an existing registration. Offer not valid on workshop-only or non-profit registrations.

---

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

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.
Read more »

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.
Read more »

In 2006, I launched the Drug Channels website to explore the economics of the U.S. reimbursement and distribution system for prescription pharmaceuticals. More than 30,000 professionals in the pharmaceutical and related industries rely on Drug Channels for timely analysis and provocative, fact-based insights.

Today, I am pleased to announce the launch of our new delivery platform: Drug Channels Video!

You can look forward to:

• Information and analysis via our new YouTube channel (Never fear. I’ll still be publishing articles on the website every week.)

• Livestream video webinars (Stay tuned next week for an announcement about our first two events.)

• Private, live virtual keynotes and remote presentations (Email me to schedule a safe social distancing event for your team.)

• Online video courses (Coming later in 2020)

Please watch my brief video introduction below. (Click here if you can’t see the video.)


I hope you and your families stay safe and healthy in these challenging times. I look forward to reconnecting with you in person soon.

This May, join Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels, for two live video webinars:

• May 1: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (REPLAY) (12:00 p.m. to 1:15 p.m. ET; $300 per site)

• May 8: Industry Update and COVID-19 Impact: PBMs & Payers (REPLAY) (12:00 p.m. to 1:15 p.m. ET; $300 per site)

• Register for replays both events (May 1 and May 8) ($500 per site for both events)

Dr. Fein will help you navigate this challenging time in U.S. drug channels. These 75-minute live events will be broadcast via Zoom from the new Drug Channels Video studio. See details below.


You can sign up for either one of these crucial educational opportunities for only $300 per site per event. We are offering special pricing of $500 if you sign up for both events.

An unlimited number of people may watch at one location. However, we recognize that it may be difficult to gather your team in one location, so we are offering significant discounts for multiple viewing sites. Please contact Paula Fein (paula@drugchannelsinstitute.com) to get special pricing information for 5 or more locations. If you purchase access for multiple sites, we will contact you for the name and email address of a contact person at each location.

Read on for more information about the events.

---

To help people affected by COVID-19 and the caregivers who are supporting them , DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund. This charity has earned a 4-star Charity Navigator rating and is a trusted philanthropic partner of Google, Coca Cola, UPS, Verizon, and many other organizations. The fund supports preparedness, containment, response, and recovery activities for those affected by the coronavirus and for the responders.

---

WHAT YOU WILL LEARN

We will help you and your team better understand key industry dynamics and how COVID-19 may alter the industry.

Dr. Fein will share DCI’s latest market data and trends from The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.

Topics for Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies:

• The key trends for retail and specialty pharmacy markets
• The new normal for prescription demand
• How COVID-19 will change the U.S. payer mix
• Will the 340B program be disrupted?
• What’s next for specialty pharmacies
• The outlook for prescription profits
• The future for the drugstores’ front-end profits
• New opportunities for pharmacists as providers
• My reflections on life in a pandemic world and beyond

Topics for Industry Update and COVID-19 Impact: PBMs & Payers:

• The key trends for PBMs
• An update on the latest prescription data
• What the changing U.S. payer mix means for PBMs and insurers
• The outlook for benefit design
• PBMs' role in Managed Medicaid
• More on the 340B Drug Pricing Program
• Disruption to the buy-and-bill channel
• Promise and perils of vertical diversification
• Further reflections on life in a pandemic world

PLUS: Dr. Fein will take your questions during the event. CLICK HERE to submit questions to Dr. Fein in advance of the events.

IMPORTANT STUFF TO KNOW

• After you register, you will receive an email with the information you will need to access our live video webinar and add it to your calendar. We will also send you reminder emails one day and one hour before the event.

• Watch and listen via any device with a web browser (computer, iPad, iPhone/Android, etc.)

• We will use Zoom technology for this webinar. You will be able to watch the live video event with your browser or by downloading the Zoom client software/app.
  

• After each event, you’ll receive a downloadable PDF with the event slides.

• If your plans change and you can’t make it on May 1 or May 8, we will provide an opportunity to watch a replay of the live video events. Unfortunately, we are unable to offer refunds.

• Pembroke Consulting clients receive free access to the webinar. Contact Tamra Feldman (admin@drugchannels.net) for details. We will automatically refund payments from anyone at a Pembroke client who purchases access using their corporate email account.

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.

Read more »

Will home infusion growth be a long-overdue correction for the buy -and-bill channel or a temporary blip that will soon vanish?

For some time, I have been tracking the evolution of the buy-and-bill system for provider-administered drugs. The data have shown that hospital outpatient departments have been displacing physician offices. Amid this shift, home infusion providers have accounted for a minority of commercial medical benefit spending and a tiny share of Medicare Part B spending.

However, the coronavirus pandemic is triggering new growth in home infusion for buy-and-bill products. Below, I highlight the early signs of a marketplace change. I believe that some of these short-term shifts in the buy-and-bill market will persist even after we have recovered from COVID-19. They may even slow the runaway growth of the 340B Drug Pricing Program.

If not, then I suppose we'll just keep living in a world with limited home infusion over and over.

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. Watch my video invitation below.

Read more »

Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
Read more »

Rumor has it that Spring has finally reached our worldwide headquarters here in beautiful downtown Philadelphia. (See photo at right.) While we wait to go outside, please enjoy this month’s selection of noteworthy news:

• The outlook for drug prices

• A outstanding (and free!) resource for tracking COVID-19 daily data

• What’s up with community oncology practices?

Plus, I share my favorite chart of 2020 (so far).

P.S. Join the more than 9,200 followers of my curated links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted: Prime Therapeutics new gene therapy offering, AmerisourceBergen’s laudable deal with the Justice Department, the Costco/Instacart deal, Rite Aid’s new CEO, clinical trial trends, vaccine pricing, and much more! I have also been tweeting under-the-radar stories about how the coronavirus is affecting drug channels.

Tomorrow (May 1), Drug Channels Institute will host the first of two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies. We'll host the second video webinar—Industry Update and COVID-19 Impact: PBMs & Payers—on 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.

Read more »

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.

---

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?
Read more »

An astrophysicist traces genealogy and art history to discover the origin of the famous motto

-- Read more on ScientificAmerican.com

The agency fell well short of its goal of evaluating local flood control efforts every five years

-- Read more on ScientificAmerican.com

I’m an astrophysicist, but that doesn’t mean I have a motivation to debunk them

-- Read more on ScientificAmerican.com

Antigen-based assays could be used in the home, but critics say their error rates are still an issue

-- Read more on ScientificAmerican.com

To build trust with traditionally underserved groups, health officials need to craft their messaging in a much more culturally sensitive way

-- Read more on ScientificAmerican.com

The pandemic is amplifying nearly every disadvantage that women in STEM already face. But institutions and the scientific community can help

-- Read more on ScientificAmerican.com

With cars off the roads, scientists can study how smog and other types of pollution change  

-- Read more on ScientificAmerican.com

Originally published in February 1967

-- Read more on ScientificAmerican.com

Events with extreme temperatures and humidity are occurring twice as often now as they were 40 years ago

-- Read more on ScientificAmerican.com

The Association of Clinical Research Organizations (ACRO) convenes discussion series that seeks to advance an industry with important health and economic impacts...

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

Investigation of combination therapies including Bayer’s chloroquine and interferon beta-1b to foster much needed solutions for patients in fight against coronavirus pandemic / Bayer Canada to make CAD 1.5 million (approximately 1 million euros) financial commitment and to supply products in support of the research / Plans to include more than 60 contributing research locations involving 6.000 patients

Employee safety and business continuity are top priorities / Wide-ranging humanitarian and social engagement / Group sales increase by 6.0 percent (Fx & portfolio adj.) to 12.845 billion euros / EBITDA before special items up by 10.2 percent to 4.391 billion euros / All divisions report higher sales and earnings – strong demand at Consumer Health / Net income advances by 20.0 percent to 1.489 billion euros / Core earnings per share increase by 9.9 percent to 2.67 euros / Outlook for 2020: impact of COVID-19 not yet reliably quantifiable

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.

Continue reading...

Pharmaceutical giants will bury treatments in a thicket of patents, making them unaffordable to the world’s poorest

• Coronavirus – latest updates
• See all our coronavirus coverage

How will the Covid-19 pandemic end? According to conventional wisdom, the crisis may ease in a few months, when some of the antiviral medicines on trial succeed. In a few years’ time, when a vaccine becomes available, we may eradicate the virus altogether.

Yet it’s unlikely that this is how the pandemic will actually play out. Although there is every indication that treatments for coronavirus may soon emerge, the mere fact of their existence is no guarantee that people will be able to access them. In fact, Covid-19 is more likely to end in the same way that every pandemic ends: treatments and vaccines will be buried in a thicket of patents – and pharmaceutical companies will ultimately make the decisions about who lives and who dies.

Related: The race to find a coronavirus treatment has one major obstacle: big pharma | Ara Darzi

Continue reading...

Stock index up more than 3% in early trading on the back of hopes for remdesivir treatment

Optimism about a potential treatment for Covid-19 gave a shot in the arm to stock markets around the world, amid claims that a drug called remdesivir has spurred rapid recovery in 113 patients.

A University of Chicago hospital participating in a study of the antiviral medication, made by US firm Gilead Sciences, found that nearly all patients suffering severe fever and respiratory symptoms were discharged within a week. A report of the study, issued by specialist healthcare publication Stat News shortly after Wall Street closed on Thursday night, spurred hopes among investors that lockdowns around the world could soon be eased.

Continue reading...

Patients were used as guinea pigs but denied access to resulting therapies. This time, Big Pharma must be held to account

• Coronavirus – latest updates
• See all our coronavirus coverage

The year I turned 11, my uncle Josiah Ssesanga was admitted to a hospital in Uganda with meningitis. It was 1994, and he was HIV positive. Between him and death stood a tattered post-civil war health system.

Treatments for HIV and Aids existed in other parts of the world, but in Uganda they were mostly limited to those used in clinical trials. For my uncle’s particular infection – cryptococcal meningitis – there was a drug called Fluconazole. But he didn’t know it existed; regardless, he wouldn’t have been able to afford it. and even among patients who took it, only 12% survived beyond six months.

Related: Macron calls for clinical trials of controversial coronavirus 'cure'

Related: Fear, bigotry and misinformation – this reminds me of the 1980s Aids pandemic | Edmund White

Continue reading...

ICI executive who helped turn its bioscience business into the pharmaceuticals giant AstraZeneca

Sir David Barnes, who has died aged 84, was the self-effacing but determined and clear-sighted chief executive who turned the bioscience interests of ICI into one of the world’s major pharmaceutical corporations, AstraZeneca.

Teased at its launch in 1993 that Zeneca sounded like a Czechoslovakian camera, Barnes responded that its performance would define its brand – and was vindicated. The first suggested name had been Zenica, but then Barnes, tracking the Bosnian conflict days before the launch, found to his horror that hostilities were threatening to spread to a previously unremarked town of that name. Alarmed that it “could become as notorious as Guernica”, he changed the spelling and held his breath.

Continue reading...

Video meeting seen as global endorsement of WHO and sign of Trump’s isolation on world stage

• Coronavirus – latest updates
• See all our coronavirus coverage

Global leaders have pledged to accelerate cooperation on a coronavirus vaccine and to share research, treatment and medicines across the globe. But the United States did not take part in the World Health Organization initiative, in a sign of Donald Trump’s increasing isolation on the global stage.

The cooperation pledge, made at a virtual meeting, was designed to show that wealthy countries will not keep the results of research from developing countries.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

Related: ‘Please don’t inject bleach’: Trump’s wild coronavirus claims prompt disbelief

Provide access to new treatments, technologies and vaccines across the world.

Commit to an unprecedented level of international partnership on research and coordinate efforts to tackle the pandemic and reduce infections.

Reach collective decisions on responding to the pandemic, recognising that the virus’s spread in one country can affect all countries.

Learn from experience and adapt the global response.

Be accountable, to the most vulnerable communities and the whole world.

Continue reading...

With substandard medicines already in wide circulation, fears are growing that coronavirus could create a lethal ‘parallel crisis’

When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.

She bought medication from a pharmacy in Ghana’s capital, Accra; when Anna’s fever didn’t subside she took her to a hospital, where they ran some tests.

The current focus on curbing Covid-19 spread means there is less focus on routine market surveillance

Related: Fight the fakes: how to beat the $200bn medicine counterfeiters | Helen Lock

Continue reading...

Trial of remdesivir shows fewer deaths and shorter hospital stays

• Coronavirus – latest updates
• See all our coronavirus coverage

The first drug against Covid-19 to show promise in trials, reducing the time seriously ill people take to recover in hospital, is unlikely to be available widely in the UK soon, it has emerged.

Forty-six people in the UK have received remdesivir as part of the European arm of an international trial. Researchers would like to have given the drug to more patients but did not have the supplies.

Related: Coronavirus: what do scientists know about Covid-19 so far?

Continue reading...

Drugmaker will manufacture and distribute vaccine if human trials are successful

• Coronavirus – latest updates
• See all our coronavirus coverage

AstraZeneca, the Cambridge-based pharmaceutical group, is teaming up with Oxford University to manufacture and distribute a coronavirus vaccine if clinical trials currently under way show it is effective.

News of the partnership boosted AstraZeneca’s share price, helping it to become Britain’s most valuable company by market capitalisation.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

Continue reading...

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine.

Italy has outlined its plans to ease the lockdown restrictions that were implemented across the country 7 weeks ago to combat the COVID-19 coronavirus pandemic.

12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19.

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.

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 Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.

Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms.

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.