Deji Sotona turned 17 in December but hasn't yet been tied down to a professional deal at United, despite the club's senior stars being impressed by him

Notre sélection des sorties du mois sur Club illico

(MedPage Today) -- A "hybrid convergent" surgical-plus-transcatheter procedure was better than endocardial catheter ablation alone for treating refractory atrial fibrillation (Afib) in the CONVERGE randomized trial. Additional ablation of the...

But if he wants to avoid being the target of their protests both before and—if he’s elected—after November, he’ll need to earn more than just their votes.

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.

Over the course of four days of football, the new AFL season went from being totally surreal to almost normal — then back to flat-out weird, writes Al Nicholson.

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.

It's usually a glamorous event in front of a packed arena, but this year's NFL draft will be broadcast from nearly 200 locations to sports-starved fans.

The experienced Test batsman is left without a Cricket Australia men's contract, while Tahlia McGrath is added to the women's list following a lengthy absence from the national team.

All members of CNN anchor Chris Cuomo's family are healthy again, according to a recent Instagram update from his wife, Purist founder Cristina Cuomo.

President Trump toured an N95 mask manufacturing plant Tuesday, with Guns N' Roses' "Live and Let Die" playing loudly in the background.

New York Gov. Andrew Cuomo acknowledged frustration with coronavirus stay-at-home orders but compared them with past sacrifices during national crises.

As more states reopen, an army of contact tracers will have to be enlisted to join the effort to stop the coronavirus.

The United States wants Mexico to reopen its border factories, even as the coronavirus spreads and worker deaths rise.

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

Jason Hehir speaks to the BBC about interviewing Michael Jordan and why the documentary series has had such an impact.

The star gave his support to five-year-old Christian Kilduff, who is raising money for the NHS

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA).  This law

The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

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.

Researchers at the National University of Singapore have developed a soft sensor and actuator to monitor bladder volume and help empty it on-demand. The device is intended to be implanted on the bladder surface during a surgical procedure to treat patients who cannot completely empty their bladders voluntarily. Patients can suffer from an underactive bladder […]

Prisym ID, a provider of data-led label and artwork management solutions, is offering instant access to its Prisym 360 SaaS medical devices labelling solution, to support medtech manufacturers’ response to Covid-19.

Stephen Sanderson, group inspection product manager and Guven Turemen, group metrology product manager, both from manufacturer Vision Engineering, discusses how manufacturers can ensure the quality of plastic components.

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.

Small to medium-sized (SME) manufacturers are calling for greater and faster financial support from the government as they confront plummeting sales, production volumes, and the prospect of job cuts amid the ongoing Covid-19 pandemic.

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

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.

Manufacturer and designer, Placon, has introduced the Face Shield Alliance to provide healthcare workers and first responders with adequate Personal Protective Equipment (PPE) during the Covid-19 pandemic.

To help with the increased demand for Personal Protective Equipment (PPE), Suffolk based manufacturer Broadwater Mouldings have turned over its 3D printer to produce protective shield frames for healthcare workers.

Manufacturer Atermit has begun producing face shields to protect users from Covid-19 using Expanded Polypropylene Particle (EPP) foam - Arpro.

First up: monthly depot formulation from Indivior

Braeburn Pharmaceuticals' CAM2038 gets positive FDA review

by Stephanie D. Fischer BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act.  The letter is posted on our website and the text is below: “On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment […]

Farxiga is the first sodium glucose co-transporter 2 inhibitor cleared by the FDA to treat heart failure with reduced ejection fraction

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) today announced that the Full Committee will hold a teleconference forum on Friday, May 8, at 12 pm (EDT) on COVID-19 testing, contact tracing and surveillance. “Our nation cannot effectively combat this terrible pandemic in the weeks and months ahead without significant testing, contact tracing and surveillance,” Pallone and Walden said.  “We look forward to hearing from health experts about what actions they believe are necessary to ensure our communities have the resources they need to fight this pandemic and to confidently reopen their local economies.” During the forum, the Committee will hear from three health experts:  Andy Slavitt, former Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) from 2015-2017.  Mark McClellan, M.D., Ph.D., former Administrator of CMS from 2004-2006 and former Commissioner of the Food and Drug Administration (FDA) from 2002-2004.  Avik Roy,Co-founder and President of the Foundation for Research on Equal Opportunity. This forum is open to the press.  Credentialed reporters interested in listening to the forum live should RSVP to cj.young@mail.house.gov by 4 pm today, Thursday, May 7. ###

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 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 »

With a few dollars, researchers replicated an instrument that typically costs thousands 

-- Read more on ScientificAmerican.com

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.

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