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

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

The data management solution is designed to help sponsors and CROs manage data more effectively, increasing cost efficiency and effectiveness.

RESCHEDULED: This event has been rescheduled for November 11-13, 2020. Click here to learn more.

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Informa Connect-CBI’s Patient Support Services Congress
June 16-18, 2020 | The Westin Princeton at Forrestal Village | Princeton, NJ
www.informaconnect.com/patient-support-services-congress

Informa Connect-CBI’s Patient Support Services Congress is a comprehensive meeting for insightful and engaging dialogue around navigating compliance hurdles while strengthening and innovating patient-oriented programs.

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

Download the agenda here and see in-depth coverage on industry trends and next-generation patient services, such as:

• Critical Regulatory Updates and Effective Strategies for Monitoring & Oversight
• Novel Approaches to Services, Program Architecture and Operational Management
• The pros and cons of different support service models
• Measuring the Success of Patient Support Programs
• Innovation, AI, Changing Distribution Models and Market Mergers
• Transparency with Charitable Organizations

Create Your Own Customized Learning Experience for 2020!

Choose from Two In-Depth Tracks

• Legal and Compliance
• Innovation and Operations

Plus! Four Tailored Summits

• Summit A: Patient Adherence – Educate, Engage and Collaborate to Enhance Outcomes
• Summit B: Case Management for Novel and Innovative Therapies
• Summit C: Strategic Planning for Product Launch
• Summit D: Primer Course for Partnering with Patients

Leading Perspectives from Industry Trendsetters:

• Robert Britting, Director, Patient Services and Strategic Solutions, Teva Pharmaceuticals
• Stella Vnook, Chief Executive Officer, Diverse Biotech
• Katherine Chaurette, Vice President healthcare Law and Compliance, Blueprint Medicines
• Kimberly Goldberg, Director, U.S Data Privacy Counsel, Novartis
• Imtiaz Hussain, Senior Director, Patient Services, Bayer
• Cory Potomis, Associate Director, Ethics & Compliance Operations, Novo Nordisk, Inc.
• And so many more!

Visit www.informaconnect.com/patient-support-services-congress for more information. Drug Channels readers will save $500 off the standard registration rate when they use code BNP667*.

*Offer applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Offer not valid on workshop only or academic/non-profit registrations.

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

Today’s guest post comes from Rob Brown, Vice President and General Manager of RxCrossroads by McKesson and Biologics by McKesson.

Rob discusses the importance of access, adherence, and affordability for specialty therapy patients who are uninsured, underinsured, or low-income. He describes three criteria companies should use to evaluate patient assistance program solutions.

Click here to learn more about program pharmacy solutions for biopharma from RxCrossroads by McKesson.

Read on for Rob’s insights.
Read more »

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.

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

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 »

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.

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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.

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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.

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.

Part D reform has faded from the policy debate. This rerun explains why it is still needed. FYI, this is my favorite article from 2020 (so far).

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

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Our high-list-price/high-rebate system remains a fundamental source of warped incentives and cascading problems within the Medicare Part D program.

For proof, check out the previously unpublished data below on market share for products that treat hepatitis C. Despite manufacturers offering products with lower list prices, Medicare Part D plans have rejected the therapeutically identical but lower-priced versions of these drugs.

List prices significantly affect seniors’ out of-pocket costs, so Part D plans are needlessly costing many of them thousands of dollars. The federal government's Medicare spending is also unnecessarily higher.

Anyone concerned about drug prices should pay close attention to this situation. Part D plans and seniors who don’t need specialty medications are benefiting, while seniors who need treatment with specialty medications are ripped off. Just another day inside the gross-to-net bubble!
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.

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.
Read more »

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

-- Read more on ScientificAmerican.com

Pandemic news highlights of the week

-- Read more on ScientificAmerican.com

2018 was a busy and productive year for ACRO’s European Scientific & Regulatory Committee, which meets quarterly in London. While the Committee focused largely on the continuing implementation of the EU Clinical Trial Regulation, there were also opportunities to engage with regulators on other topics ranging from European regulatory strategy to Advanced Therapies to the urgent challenges of Brexit.

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

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...

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

Two companies jointly have capacity to manufacture hundreds of millions of doses

• Coronavirus – latest updates
• See all our coronavirus coverage

Two of the world’s biggest vaccine companies have joined forces in an “unprecedented” collaboration to develop a Covid-19 vaccine.

GlaxoSmithKline and Sanofi, which combined have the largest vaccine manufacturing capability in the world, are working together on a hi-tech vaccine they say could be in human trials within months.

What is Covid-19?

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...

Government bodies, industry and charities to collaborate in research efforts

• Coronavirus – latest updates
• See all our coronavirus coverage
• Coronavirus vaccine – when will we have one?

The government has announced a new vaccines taskforce to help the development of a vaccine for Covid-19 and ensure its rapid production and rollout if one arrives.

The business secretary, Alok Sharma, also gave details of cash grants for work into both vaccines and potential treatments. Among the projects receiving cash is one led by Public Health England (PHE), which hopes to develop an antibody drug, something that has the potential to work as both a prophylactic and a treatment for those infected.

Related: The hunt for a coronavirus vaccine

Hydroxychloroquine, also known by its brand name, Plaquenil, is a drug used to treat malaria. It is a less toxic version of chloroquine, another malaria drug, which itself is related to quinine, an ingredient in tonic water.

Continue reading...

The pressing need to find a solution to the pandemic means risks and shortcuts may have to be taken

• Coronavirus – latest updates
• See all our coronavirus coverage

The stakes could hardly be higher; the prize still tantalisingly out of reach. It is no exaggeration to say that the fate of many millions of people rests on the discovery of a vaccine for Covid-19 – the only sure escape route from the pandemic.

Yet the optimism that accompanied the launch of Oxford University’s human trials this week has to be put in context, and the hurdles facing the scientists need to be understood.

Continue reading...

Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit

• Coronavirus latest updates

• See all our coronavirus coverage

Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna

In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments

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...

The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banks

• Coronavirus latest updates
• See all our coronavirus coverage

There was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.

Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.

The piping through which emergency credit must flow is atrophied and weak

Continue reading...

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.

Scott Morrison, the Australian Prime Minister, has called for an investigation into the origins of the COVID-19 coronavirus, as Australia becomes one of China’s most vocal critics of its response to the pandemic.

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.

A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection.

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.

British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.

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.

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.

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.

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.

AZ has pledged to make the vaccine at cost for the duration of the pandemic

Ramps up capacity for testing across the country

Drug has shown “clinically meaningful responses” for basal cell carcinoma

Two antibody cocktails for COVID-19 could be available as early as this autumn

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 ELAN.

The European medicines regulator has OK’d a label update for AstraZeneca’s Lokelma (sodium zirconium…