The Trump-Biden fight is already underway, and it's totally online. What it's like to spend seven days following their whirlwind all-digital faceoff.

The impact of coronavirus is not just being felt in the NRL, as community and junior rugby league clubs struggle to stay afloat because of the current health crisis.

The NRL is being hit hard by the financial effect of coronavirus, which is why one of the game's greatest players wants the league to consider reducing its number of teams from 16 to 12.

In what it describes as a "relief", the AFL receives a line of credit with two major banks that will help the league continue operating during the coronavirus pandemic.

On a recent podcast, actor Kevin Spacey saw parallels between the coronavirus crisis and his Hollywood downfall after being accused of sexual misconduct.

L.A.-based live music video streaming service LiveXLive said it plans to acquire PodcastOne, a Beverly Hills-based podcast production company. The all-stock transaction is the latest sign of growth in the podcast industry.

The U.S. death toll from the coronavirus outbreak has surpassed that of 9/11, even the Vietnam War. Here's a look at COVID-19's place in history.

Most presidents act as consoler-in-chief in times of national crisis. Trump has struggled to show any empathy with victims or survivors of COVID-19.

With imports slowing, many African nations are learning the importance of local manufacturing.

Join Kleinfeld, Kaplan & Becker, LLP and Vicente Sederberg on Tuesday, April 7 at 2:15 p.m. ET for a live webinar on Hemp and CBD – FDA Update and the Impact of COVID-19. Since 2015, KKB and VS have worked closely together in advising clients on the ever-evolving legal landscape for hemp-derived products. During this

The post LIVE WEBINAR: Hemp & CBD: FDA Update and the Impact of COVID-19 appeared first on Kleinfeld Kaplan & Becker LLP.

Thermoformed packaging company Lacerta has managed to ship over three million Personal Protective Equipment (PPE) face shields to healthcare and frontline workers, in response to the coronavirus pandemic.

Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.

Maurits Lugard, a partner, Josefine Sommer, a senior associate, and Anouchka Hoffman, an associate, at Sidley Austin, examines the consequences that come with the delay of the application of EU Medical Devices Regulation by one year.

Munich-based software start-up Climedo Health has published a whitepaper assessing the "Impact of Covid-19 on the medtech industry".

HealthBeacon, a medication adherence technology company, has launched a new Covid-19 support offering for patients on injectable therapies.

Adhesives specialist Intertronics has launched a new campaign to highlight the ways that assembly companies can simplify processes, improve output and reduce waste.

Chemicals company Lubrizol is helping with the pandemic by making materials used in Personal Protection Equipment (PPE) as well as hand sanitiser and products to help treat patients who are fighting the virus.

Dr Archana Nagarajan, a freelance scientist specialising in medical devices at Kolabtree, the online freelance platform for scientists, explains the changes made to the European medical device market in light of the pandemic.

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

It’s a unique and troubling time. We are all of course concerned about the coronavirus and its disruption to our personal and professional lives.

I presume that life will return to normal later this year. But what happens then? Will there be long-term changes to how the drug channel operates? Will we see permanent changes in behavior, policy, and industry structure?

To answer these questions, I want to tap the collective insights of Drug Channels’ 30,000+ audience.


This survey should take 10 minutes or less. I will provide a full review of the results next week on Drug Channels. The survey will close on March 20.

You can respond anonymously. Any information you provide will be kept confidential. Per Drug Channels' long-standing policy, I never publish, release, or disclose any personal data without your permission.

Thanks in advance for sharing your insights.

Regards,
Adam

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!
Read more »

Today’s post is the second in our three-part investigation of the ultimate impact of the coronavirus on the drug channel. Here is a link to the first part of our survey analysis: Coronavirus Industry Impact: Patients, Pharmacies, and Wholesalers (Part 1). That article includes details about the methodology and respondents.

Today, I review how people in the industry think coronavirus will affect:

• Federal drug pricing legislation

• FDA new drug approvals

• Public support for single-payer health insurance

• Third-party payment for prescription drugs

I also highlight survey respondents’ comments on whether the current situation will bring overseas pharmaceutical manufacturing back to the United States.

Tomorrow, I’ll examine survey responses that address how the coronavirus may affect the public’s perception of the industry’s participants. In the meantime, remember that every day is no pants day when you work from home.
Read more »

Today is the final installment of our three-part investigation into the coronavirus’ ultimate impact on the drug channel.

Below, I examine expectations about how the coronavirus will affect the public’s perception of various industry participants. We explore what our survey respondents said about:

• Pharmacies
• Pharmaceutical manufacturers
• Hospitals
• Wholesalers
• Pharmacy benefit managers and plan sponsors
• Insurance companies.

In these early stages of this crisis, my crystal ball is as cloudy as yours. Let’s hope that the country will stabilize within a few months. I may then rerun the survey to determine how (if at all) everyone’s perspective has changed.
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.

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 »

They don’t stand on one leg around just anybody but often prefer certain members of the flock.

-- Read more on ScientificAmerican.com

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.

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

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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:

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Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb,…

The fallout from the COVID-19 pandemic has been challenging for many life sciences companies due to a…

A multi-year collaboration between China’s Innovent Biologics and USA-based Eli Lilly is bearing fruit,…

Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist…

Barrday Inc. and two related companies have agreed to pay the United States more than $1 million to resolve allegations that they violated the False Claims Act in connection with their role in the weaving of Zylon fabric used in the manufacture and sale of defective Zylon bullet-proof vests. Barrday, headquartered in Cambridge, Ontario, Canada, is a weaver of ballistic fabrics and designs and produces specialty industrial textiles.

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 former finance director of an Orange County, Calif.-based valve company pleaded guilty today in connection with his role in a conspiracy to pay approximately $628,000 in bribes to numerous foreign government officials.

A fish wholesaler, its owner and an employee have all pleaded guilty in U.S. District Court for the District of Columbia for the illegal purchase and sale of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.

Four individuals have been arrested and charged with carrying out a racially-motivated beating and conspiring to interfere with the civil rights of an African-American man in Nampa, Idaho.

A federal grand jury in Newark, N.J., has returned an eight-count indictment charging a Liberian company that manages an oceangoing bulk carrier vessel, M/V Myron N, along with the ship’s chief engineer and second engineer for covering up discharges of oil-contaminated waste at sea.

An employee of a Sewell, N.J., company that provided temporary electrical utilities pleaded guilty today to participating in a fraud conspiracy at an Environmental Protection Agency (EPA)-designated Superfund site in New Jersey.

A Middlesex, N.J., industrial pipes, valves and fittings supply company and its co-owner pleaded guilty today to participating in a fraud conspiracy at two U.S. Environmental Protection Agency (EPA)-designated Superfund sites in New Jersey. The sites are Federal Creosote, located in Manville, N.J., and Diamond Alkali, located in Newark, N.J.

The Department announced today that it has entered into a consent decree with Stimson Lumber Company (Stimson) that, if approved by the court, will resolve the Department’s complaint, also filed today, that Oregon-based Stimson failed to reemploy Oregon reservist David Eckhardt in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).

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.

An Iranian citizen and his Tehran business have been charged with purchasing helicopter engines and advanced aerial cameras for fighter bombers from U.S. firms and illegally exporting them to Iran using companies in Malaysia, Ireland and the Netherlands. Among the alleged recipients of these U.S. goods was an Iranian military firm that has since been designated by the United States for being owned or controlled by entities involved in Iran’s nuclear and ballistic missile program.

Edward B. Bartoli, a Clearwater, Fla., resident and former attorney, was sentenced to 10 years in prison by U.S. District Judge Charles R. Norgle of Chicago. Bartoli is the last of six defendants to be sentenced after they were convicted of various tax crimes in May 2008. Prior to his conviction, Bartoli was a founder of Aegis and its legal director.

The Department is making grant funding available for public education programs concerning immigration-related employment discrimination. The Office of Special Counsel for Immigration Related Unfair Employment Practices (OSC), a section of the Department’s Civil Rights Division, announced the availability of funds for public education programs regarding employees’ rights and employers’ obligations under the anti-discrimination provision of the Immigration and Nationality Act (INA).

Six former executives of an Orange County, Calif.-based valve company were charged today in connection with a conspiracy to secure contracts by paying bribes to officials of foreign state-owned companies as well as officers and employees of foreign and domestic private companies. The contracts resulted in net profits to the company of approximately $46.5 million. According to the indictment, the defendants allegedly engaged in a bribery conspiracy from approximately 1998 through 2007.

Three international airline companies—Luxembourg-based Cargolux Airlines International S.A., Japan-based Nippon Cargo Airlines Co. Ltd. (NCA), and Korea-based Asiana Airlines Inc.—have each agreed to plead guilty and pay criminal fines totaling $214 million for conspiring to fix prices in the air cargo industry. In addition, Asiana was charged with fixing the passenger fares charged on flights from the United States to Korea.

Texas Oil and Gathering Inc., its owner John Kessel and its operations manager Edgar Pettijohn pleaded guilty today in U.S. District Court in Houston to criminal violations related to the disposal of refinery wastes at an underground injection well in violation of the Safe Drinking Water Act.