Revolutionizing cardiac device data management

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The show was postponed last month because of the COVID-19 pandemic

The former Coronation Street star has sparked envy with her stunning decor

The Coronation Street star is a volunteer during the coronavirus crisis

Iceland has put in a job offer for the Salford comic after Tesco didn't hire him

The Troublemaker singer has spoken out after pranking his girlfriend on TikTok during lockdown

By Suzan Onel and Vanessa Fulton On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a pandemic (“Guidance”).  The Guidance provides recommendations that affect adverse event reporting obligations for drugs, biologics, medical devices, combination products, and dietary supplements. To summarize, FDA states in the Guidance that

The post FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics 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 […]

LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals ECG Remote Monitoring Patch. The patch, integrated with a remote monitoring platform, is designed as a continuous electrocardiography (ECG) and heart rate monitor. The ECG Remote Monitoring Patch is disposable and captures data for up to three days. The device […]

In light of Covid-19, Smithers Thermoplastic and Silicone Elastomers US Summits will now take place in a virtual format.

During Covid-19, magnetic separation, metal detection, and conveying products are essential because they support the plastics processing industry and protect plastic from metal contamination.

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

Roche’s antibody test for Covid-19 has been given the CE mark and has been issued Emergency Use Authorisation from the US Food and Drug Administration.

3D printing company Formlab​s has received emergency use authorisation (EUA) from the U.S. Food and Drug Administration (FDA) to print bi-level positive airway pressure (BiPAP) adapters designed by Northwell Health, a New York healthcare provider.

Engineers from the University of Glasgow are responding to the coronavirus pandemic by producing up to 1,000 pieces of Personal Protective Equipment (PPE) each day.

Experts discuss recent cancellation of first-in-class drug

Get the inside information on what industry does and does NOT want from their academic counterparts: Join us June 16, 3-4 p.m. EDT for Insider’s Guide to Effective Partnering at BIO 2011, a FREE AUTM webinar to help you prepare for the BIO convention in Washington, DC, June 27-30.

Alexion Pharmaceuticals CEO Ludwig Hantson has made no secret that he wants to diversify his company’s drug portfolio and he has shown willingness to open the corporate checkbook to accomplish that goal. Last October, Alexion (NASDAQ: ALXN) struck a $930 million deal to acquire Achillion Pharmaceuticals, a biotech whose lead drug complements the Boston company’s […]

Chief Executive Mike Thompson is to retire from his role at the Association of the British Pharmaceutical Industry (ABPI) by the end of this year.

His decision to leave the association marks the end of a three-year run beginning in March 2016, when stepped in to take up the mantle from Alison Clough, who had served as the acting Chief Executive for much of 2015.

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Chief Executive of Gulf Pharmaceutical Industries, Jerome Carle, is stepping down from his post at the United Arab Emirates drug manufacturer facing mounting pressure.

Julphar, one of the biggest generic drugs manufacturers in the Middle East and North Africa said Jerome Carle has “tendered his resignation” and the board has accepted it. His last working day will be December 8th.

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Sir Mark Walport, Chief Executive of UK Research and Innovation (UKRI), the national funding agency responsible for science and research investment in the UK, has announced he is to retire for the role next year.

The decision to leave the organisation in 2020 will mark the end of a three-year tenure at its helm, beginning in 2017 when Walport was appointed to “create a single, ambitious organisation and provide the UK with a world class funding system to keep it at the forefront of global research and innovation”.

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Pfizer’s executive chairman Ian Read, is to be succeeded by CEO Albert Bourla with a date to start the post being January 1st 2020.

Mr Bourla, who joined Pfizer’s animal health division in 1993, succeeded Mr. Read from Chief Operating Officer as Chief Executive earlier this year in January, and will now go on to serve as Executive Chairman.

Mr Read has spent nine years in the role and has been at the company for a total of 41 years, first arriving in 1978 and becoming CEO in 2010, joining the board the following year.

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The Association of the British Pharmaceutical Industry (ABPI) has appointed Dr Richard Torbett as its new Chief Executive. He will assume the position on 1 January 2020.

The appointment comes after his predecessor, Mike Thompson, stepped down in June. He had served in the role since March 2016. Torbett was unanimously selected by the ABPI board after an external recruitment process with an executive search agency.

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Saniona has announced that Rami Levin will take over as the Chief Executive Officer of the company as it seeks to transition into a fully-fledge biopharmaceuticals company, with a focus on rare diseases.

Levin was appointed by the Board of Directors and the company’s founders. His appointment takes immediate effect.

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Nordic Nanovector has appointed Dr Lars Nieba as the interim Chief Executive Officer. He is currently the company’s Chief Technology Officer and replaces Eduardo Bravo who as of today has left Nordic to pursue other career opportunities.

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The Chief Executive Officer of Immuron, Gary S. Jacob, has resigned as CEO and as a member of the Board due to restructering taking place to prepare the company for a post-coronavirus world.

In a statement, the company said it was the first move to help the “preservation of capital to allow the company to weather the current trading conditions pending strengthening of the travel market. This will involve radical cost-cutting and deferring certain research and development activities.”

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BrainStorm Cell Therapeutics, a firm developing cellular therapies to tackle neurodegenerative diseases, has named industry Big Pharma veteran Dr David Setboun as its new Executive Vice President and Chief Operating Officer.

Dr Setboun has served for two decades at some of the biggest names in pharma. His most recent role was Vice President of Corporate Development, Strategy & Business at Life Biosciences, where he helped drive development of a range of vital commercial, operating and funding milestones.

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A judge ruled recently that a patient, known as MB, who had occupied an NHS bed for over a year, must vacate it and instead receive care in the community.

The post Obtaining a Hospital Bed in the COVID-19 Pandemic: A Legal Perspective appeared first on Bill of Health.

“John, I’m very aware of your family’s journey, Twelve years ago I was one of the producers considering bidding on your life rights.”

The results, if they hold up, are likely to result in many patients getting the medicine, and could upend decades of orthodoxy among cardiologists.

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 launch of the renamed, newly independent company follows its acquisition by Altaris Capital Partners.

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 »

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

-- Read more on ScientificAmerican.com

It’s essential if we’re going to protect our planet

-- Read more on ScientificAmerican.com

What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto...

Coronavirus crisis: Employee safety at the top of the agenda / First DAX company to hold virtual stockholders’ meeting / Strategic and operational targets attained in 2019 / Dividend of 2.80 euros per share proposed / Good start to fiscal 2020 / Winkeljohann to succeed Wenning as Supervisory Board Chairman

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...

Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead

• Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?
• Sign up for Guardian Australia’s daily coronavirus email
• Download the free Guardian app to get the most important news notifications

The US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.

The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”.

Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

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...

NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year.

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.

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.